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e-Clean Cemented Abutment DECAR638H

by Dentis Co., Ltd

Ref DECAR638H

e-Clean Cemented Abutment DECAR638H is a device classified as Class IIb in the EU and Class II in the US made by Dentis Co., Ltd, registered in EUDAMED on 8 Oct 2026 (Basic UDI-DI B-08806169103512), cleared under FDA 510(k) K171027 on 6 Sep 2017 and listed in FDA GUDID since 31 Aug 2015 (UDI-DI 08806169103512), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K171027

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08806169103512 Basic UDI-DI 08806169103512UDI-DIDate8 Oct 2026RegisteredStatusActive
United StatesFDA 510(k) GUDID from GUDID NumberK171027 Date6 Sep 2017IssuedStatusActive
United StatesGUDID listing GUDID Number08806169103512 UDI-DI Date31 Aug 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08806169103512 registered 8 Oct 2026 Active
  • FDA 510(k) K171027 decided 6 Sep 2017 Active
  • FDA GUDID UDI-DI 08806169103512 listed 31 Aug 2015 Listed

Timeline

3 dated events

  1. Listed FDA GUDID 08806169103512
  2. Cleared FDA 510(k) K171027
  3. Registered EUDAMED B-08806169103512

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  • Withdrawn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
Cemented Abutment EUDAMED
e-Clean Cemented Abutment GUDID
Generic name
Dental implant suprastructure, permanent, preformed
Model / reference
DECAR638H
Primary DI / UDI-DI
08806169103512
Basic UDI-DI
B-08806169103512
510(k) Number
FDA product code
NHA
EMDN code
P01020180 Dental implants - accessories
GMDN term
Dental implant suprastructure, permanent, preformed
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.3630
EU registration type
Legacy device (under a directive)
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes
ImplantableEUDAMED
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 08806169103512: 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 suprastructure, permanent, preformed

Cleared under the same submission (K171027)

and 8 more cleared under K171027

Similar devices in this category

Other devices filed under DENTAL IMPLANTS - ACCESSORIES.

Other devices from Dentis Co., Ltd

See all devices from Dentis Co., Ltd →

Properties

  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Implantable NoEUDAMEDYesGUDID
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)