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GBR System SDS-140-060

by Surgident

Ref SDS-140-060

GBR System SDS-140-060 is a device classified as Class IIb in the EU and Class II in the US made by Surgident, registered in EUDAMED on 30 Sep 2026 (Basic UDI-DI B-08800041000043), cleared under FDA 510(k) K170697 on 24 May 2018 and listed in FDA GUDID since 31 Aug 2018 (UDI-DI 08800041000043), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K170697

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800041000043 Basic UDI-DI 08800041000043UDI-DIDate30 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800041000043 UDI-DI Date31 Aug 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK170697 Date24 May 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08800041000043 registered 30 Sep 2026 Active
  • FDA 510(k) K170697 decided 24 May 2018 Active
  • FDA GUDID UDI-DI 08800041000043 listed 31 Aug 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K170697
  2. Listed FDA GUDID 08800041000043
  3. Registered EUDAMED B-08800041000043

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
GBR System
Generic name
Craniofacial bone screw, non-bioabsorbable, non-sterile
Device name
Bone Screw of GBR System
Model / reference
SDS-140-060
Primary DI / UDI-DI
08800041000043
Basic UDI-DI
B-08800041000043
510(k) Number
FDA product code
DZL
EMDN code
Q010302 Dental graft devices
GMDN term
Craniofacial bone screw, non-bioabsorbable, non-sterile
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.4880
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Craniofacial bone screw, non-bioabsorbable, non-sterile

Cleared under the same submission (K170697)

and 8 more cleared under K170697

Similar devices in this category

Other devices filed under DENTAL GRAFT DEVICES.

Other devices from Surgident

See all devices from Surgident →

Properties

  • Sterilise before use
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)