Skip to content

RN Octagon angled Abutment 032160

by BIO CONCEPT Co., Ltd.

Ref 032160

RN Octagon angled Abutment 032160 is a device classified as Class IIb in the EU and Class II in the US made by BIO CONCEPT Co., Ltd., registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI B-06947600301295), cleared under FDA 510(k) K150388 on 12 Nov 2015 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 06947600301295), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K150388

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06947600301295 Basic UDI-DI 06947600301295UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06947600301295 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK150388 Date12 Nov 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-06947600301295 registered 4 Nov 2026 Active
  • FDA 510(k) K150388 decided 12 Nov 2015 Active
  • FDA GUDID UDI-DI 06947600301295 listed 1 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K150388
  2. Listed FDA GUDID 06947600301295
  3. Registered EUDAMED B-06947600301295

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  • Withdrawn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
RN Octagon angled Abutment
Generic name
Dental implant system
Device name
Dental Implant Attachments
Model / reference
032160
Primary DI / UDI-DI
06947600301295
Basic UDI-DI
B-06947600301295
510(k) Number
FDA product code
DZE
EMDN code
P01020180 Dental implants - accessories
GMDN term
Dental implant system
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 · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 06947600301295: EUDAMED states No, FDA GUDID states Yes.

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 implant system

Cleared under the same submission (K150388)

and 8 more cleared under K150388

Similar devices in this category

Other devices filed under DENTAL IMPLANTS - ACCESSORIES.

Other devices from BIO CONCEPT Co., Ltd.

See all devices from BIO CONCEPT Co., Ltd. →

Properties

  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Implantable
  • Serial number
  • Manufacturing date
Other properties (18, all answered No)