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OneGuide SS Implant Driver

Surgical Instrument System

Class IMDR 2017/745On the marketReusable

Manufacturer: OSSTEM IMPLANT Co., Ltd.
Manufacturer SRN: KR-MF-000020006
UDI-DI: 08809917108272
Basic UDI-DI: 88000406CLASSIBS25V
Reference: OGFDR57S
EMDN: L159099
EMDN description: ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 06.08.2026 03:51

Manufacturer products Authorised representative products Authorised representative actors View details

Composite Spreader Fig. D11TS Ø 0.25 mm Stainless Steel

Probes & Dilators

Class IMDR 2017/745On the marketReusable

Manufacturer: Surtex Instruments Ltd
Manufacturer SRN: GB-MF-000023183
UDI-DI: 05055445997199
Basic UDI-DI: 50554459PROBEDILATE56
Reference: DE-565-11 C
EMDN: L159012
EMDN description: ENDODONTIC SPREADERS AND PLUGGERS, REUSABLE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 03:45

Manufacturer products Authorised representative products Authorised representative actors View details

ACT® Drills

Non-Sterile powered surgically invasive instrument

Class IIaMDR 2017/745On the marketCMR substanceReusable

Manufacturer: ZimVie US Corp LLC
Manufacturer SRN: US-MF-000048255
UDI-DI: 00844868000402
Basic UDI-DI: 844868AEHY
Reference: ACT4818
EMDN: L159099
EMDN description: ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER
First on market country: Spain
Authorised representative: ZimVie Spain S.L.U.
Last updated: 06.08.2026 03:43

Manufacturer products Authorised representative products Authorised representative actors View details

Resin Marker

Surgical Instrument System

Class IMDR 2017/745On the marketReusable

Manufacturer: OSSTEM IMPLANT Co., Ltd.
Manufacturer SRN: KR-MF-000020006
UDI-DI: 08809917100733
Basic UDI-DI: 88000406CLASSIBS25V
Reference: RSMRKS
EMDN: L159099
EMDN description: ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 06.08.2026 03:37

Manufacturer products Authorised representative products Authorised representative actors View details

Spreader Fig. D11TS Ø 0.20 mm / 21 mm Stainless Steel

Probes & Dilators

Class IMDR 2017/745On the marketReusable

Manufacturer: Surtex Instruments Ltd
Manufacturer SRN: GB-MF-000023183
UDI-DI: 05055445997182
Basic UDI-DI: 50554459PROBEDILATE56
Reference: DE-565-11
EMDN: L159012
EMDN description: ENDODONTIC SPREADERS AND PLUGGERS, REUSABLE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 03:30

Manufacturer products Authorised representative products Authorised representative actors View details

ACT® Drills

Non-Sterile powered surgically invasive instrument

Class IIaMDR 2017/745On the marketCMR substanceReusableSterile

Manufacturer: ZimVie US Corp LLC
Manufacturer SRN: US-MF-000048255
UDI-DI: 00844868000396
Basic UDI-DI: 844868AEHY
Reference: ACT4813
EMDN: L159099
EMDN description: ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER
First on market country: Spain
Authorised representative: ZimVie Spain S.L.U.
Last updated: 06.08.2026 03:27

Manufacturer products Authorised representative products Authorised representative actors View details

OneGuide SS NoMount Driver

Surgical Instrument System

Class IMDR 2017/745On the marketReusable

Manufacturer: OSSTEM IMPLANT Co., Ltd.
Manufacturer SRN: KR-MF-000020006
UDI-DI: 08809917098900
Basic UDI-DI: 88000406CLASSIBS25V
Reference: OGNMDW67S
EMDN: L159099
EMDN description: ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 06.08.2026 03:23

Manufacturer products Authorised representative products Authorised representative actors View details

ACT® Drills

Non-Sterile powered surgically invasive instrument

Class IIaMDR 2017/745On the marketCMR substanceReusable

Manufacturer: ZimVie US Corp LLC
Manufacturer SRN: US-MF-000048255
UDI-DI: 00844868000389
Basic UDI-DI: 844868AEHY
Reference: ACT4285
EMDN: L159099
EMDN description: ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER
First on market country: Spain
Authorised representative: ZimVie Spain S.L.U.
Last updated: 06.08.2026 03:21

Manufacturer products Authorised representative products Authorised representative actors View details

OneGuide SS NoMount Driver

Surgical Instrument System

Class IMDR 2017/745On the marketReusable

Manufacturer: OSSTEM IMPLANT Co., Ltd.
Manufacturer SRN: KR-MF-000020006
UDI-DI: 08809917098887
Basic UDI-DI: 88000406CLASSIBS25V
Reference: OGNMDR57S
EMDN: L159099
EMDN description: ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 06.08.2026 03:19

Manufacturer products Authorised representative products Authorised representative actors View details

Spreader Fig. D11T Ø 0.23 mm / 23 mm Stainless Steel

Probes & Dilators

Class IMDR 2017/745On the marketReusable

Manufacturer: Surtex Instruments Ltd
Manufacturer SRN: GB-MF-000023183
UDI-DI: 05055445997175
Basic UDI-DI: 50554459PROBEDILATE56
Reference: DE-563-11
EMDN: L159012
EMDN description: ENDODONTIC SPREADERS AND PLUGGERS, REUSABLE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 03:13

Manufacturer products Authorised representative products Authorised representative actors View details

ACT® Drills

Non-Sterile powered surgically invasive instrument

Class IIaMDR 2017/745On the marketCMR substanceReusable

Manufacturer: ZimVie US Corp LLC
Manufacturer SRN: US-MF-000048255
UDI-DI: 00844868000372
Basic UDI-DI: 844868AEHY
Reference: ACT4218
EMDN: L159099
EMDN description: ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER
First on market country: Spain
Authorised representative: ZimVie Spain S.L.U.
Last updated: 06.08.2026 03:11

Manufacturer products Authorised representative products Authorised representative actors View details

Composite¬ô Spreader Fig. D11S Ø 0.23 mm Stainless Steel

Probes & Dilators

Class IMDR 2017/745On the marketReusable

Manufacturer: Surtex Instruments Ltd
Manufacturer SRN: GB-MF-000023183
UDI-DI: 05055445997168
Basic UDI-DI: 50554459PROBEDILATE56
Reference: DE-561-11 C
EMDN: L159012
EMDN description: ENDODONTIC SPREADERS AND PLUGGERS, REUSABLE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 03:01

Manufacturer products Authorised representative products Authorised representative actors View details

Spreader Fig. D11S Ø 0.35 mm / 23 mm Stainless Steel

Probes & Dilators

Class IMDR 2017/745On the marketReusable

Manufacturer: Surtex Instruments Ltd
Manufacturer SRN: GB-MF-000023183
UDI-DI: 05055445997151
Basic UDI-DI: 50554459PROBEDILATE56
Reference: DE-561-11
EMDN: L159012
EMDN description: ENDODONTIC SPREADERS AND PLUGGERS, REUSABLE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 02:49

Manufacturer products Authorised representative products Authorised representative actors View details

OneGuide KS NoMount Driver

Surgical Instrument System

Class IMDR 2017/745On the marketReusable

Manufacturer: OSSTEM IMPLANT Co., Ltd.
Manufacturer SRN: KR-MF-000020006
UDI-DI: 08809917098870
Basic UDI-DI: 88000406CLASSIBS25V
Reference: OGNMDR57K
EMDN: L159099
EMDN description: ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 06.08.2026 02:43

Manufacturer products Authorised representative products Authorised representative actors View details

ACT® Drills

Non-Sterile powered surgically invasive instrument

Class IIaMDR 2017/745On the marketCMR substanceReusable

Manufacturer: ZimVie US Corp LLC
Manufacturer SRN: US-MF-000048255
UDI-DI: 00844868000365
Basic UDI-DI: 844868AEHY
Reference: ACT4213
EMDN: L159099
EMDN description: ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER
First on market country: Spain
Authorised representative: ZimVie Spain S.L.U.
Last updated: 06.08.2026 02:42

Manufacturer products Authorised representative products Authorised representative actors View details

Composite¬ô Spreader Fig. D11 Ø 0.30 mm Stainless Steel

Probes & Dilators

Class IMDR 2017/745On the marketReusable

Manufacturer: Surtex Instruments Ltd
Manufacturer SRN: GB-MF-000023183
UDI-DI: 05055445997144
Basic UDI-DI: 50554459PROBEDILATE56
Reference: DE-559-11 C
EMDN: L159012
EMDN description: ENDODONTIC SPREADERS AND PLUGGERS, REUSABLE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 02:34

Manufacturer products Authorised representative products Authorised representative actors View details

Spreader Fig. D11 Ø 0.40 mm - Tip Length 23 mm Stainless Steel

Probes & Dilators

Class IMDR 2017/745On the marketReusable

Manufacturer: Surtex Instruments Ltd
Manufacturer SRN: GB-MF-000023183
UDI-DI: 05055445997137
Basic UDI-DI: 50554459PROBEDILATE56
Reference: DE-559-11
EMDN: L159012
EMDN description: ENDODONTIC SPREADERS AND PLUGGERS, REUSABLE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.08.2026 02:24

Manufacturer products Authorised representative products Authorised representative actors View details

OneGuide US NoMount Driver

Surgical Instrument System

Class IMDR 2017/745On the marketReusable

Manufacturer: OSSTEM IMPLANT Co., Ltd.
Manufacturer SRN: KR-MF-000020006
UDI-DI: 08809917098863
Basic UDI-DI: 88000406CLASSIBS25V
Reference: OGNMDR50U
EMDN: L159099
EMDN description: ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 06.08.2026 02:17

Manufacturer products Authorised representative products Authorised representative actors View details

ACT® Drills

Non-Sterile powered surgically invasive instrument

Class IIaMDR 2017/745On the marketCMR substanceReusable

Manufacturer: ZimVie US Corp LLC
Manufacturer SRN: US-MF-000048255
UDI-DI: 00844868000358
Basic UDI-DI: 844868AEHY
Reference: ACT3820
EMDN: L159099
EMDN description: ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER
First on market country: Spain
Authorised representative: ZimVie Spain S.L.U.
Last updated: 06.08.2026 02:15

Manufacturer products Authorised representative products Authorised representative actors View details

OneGuide SS NoMount Driver

Surgical Instrument System

Class IMDR 2017/745On the marketReusable

Manufacturer: OSSTEM IMPLANT Co., Ltd.
Manufacturer SRN: KR-MF-000020006
UDI-DI: 08809917098856
Basic UDI-DI: 88000406CLASSIBS25V
Reference: OGNMDR50S
EMDN: L159099
EMDN description: ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER
First on market country: Czechia
Authorised representative: Obelis s.a.
Last updated: 06.08.2026 02:11

Manufacturer products Authorised representative products Authorised representative actors View details