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Bl-Osc-H

by Z-Systems AG

Ref BL-OSC-H

Bl-Osc-H is a device classified as Class IIb in the EU and Class II in the US made by Z-Systems AG, registered in EUDAMED on 29 Apr 2026 (Basic UDI-DI B-07640166760870), cleared under FDA 510(k) K190243 on 3 Jan 2020 and listed in FDA GUDID since 5 Apr 2024 (UDI-DI 07640166760870), active as of 12 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 12 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K190243

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Oct 2026.

Regulatory status

as of registry sync 12 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07640166760870 Basic UDI-DI 07640166760870UDI-DIDate29 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07640166760870 UDI-DI Date5 Apr 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK190243 Date3 Jan 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07640166760870 registered 29 Apr 2026 Active
  • FDA 510(k) K190243 decided 3 Jan 2020 Active
  • FDA GUDID UDI-DI 07640166760870 listed 5 Apr 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K190243
  2. Listed FDA GUDID 07640166760870
  3. Registered EUDAMED B-07640166760870

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  • Withdrawn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

Generic name
Dental prosthesis/implant abutment screw
Model / Ref / Catalog
BL-OSC-H
Primary DI / UDI-DI
07640166760870
Basic UDI-DI
B-07640166760870
510(k) Number
FDA product code
DZE
EMDN code
P01020101 Dental implants
GMDN term
Dental prosthesis/implant abutment screw
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.3640
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 · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

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: Dental prosthesis/implant abutment screw

Cleared under the same submission (K190243)

and 4 more cleared under K190243

Similar devices in this category

Other devices filed under DENTAL IMPLANTS.

Other devices from Z-Systems AG

See all devices from Z-Systems AG →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (17, all answered No)