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i-Clean Temporary Abutment Set DIPT10NS

by Dentis Co., Ltd

Ref DIPT10NS

i-Clean Temporary Abutment Set DIPT10NS 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-08800053080910), cleared under FDA 510(k) K111364 on 1 Feb 2012 and listed in FDA GUDID since 9 Dec 2022 (UDI-DI 08800053080910), 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) K111364

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-08800053080910 Basic UDI-DI 08800053080910UDI-DIDate8 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800053080910 UDI-DI Date9 Dec 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK111364 Date1 Feb 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08800053080910 registered 8 Oct 2026 Active
  • FDA 510(k) K111364 decided 1 Feb 2012 Active
  • FDA GUDID UDI-DI 08800053080910 listed 9 Dec 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K111364
  2. Listed FDA GUDID 08800053080910
  3. Registered EUDAMED B-08800053080910

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  • Withdrawn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
i-Clean Temporary Abutment EUDAMED
i-Clean Temporary Abutment Set GUDID
Generic name
Dental implant suprastructure, temporary, preformed, single-use
Model / reference
DIPT10NS
Primary DI / UDI-DI
08800053080910
Basic UDI-DI
B-08800053080910
510(k) Number
FDA product code
NHA
EMDN code
P01020101 Dental implants
GMDN term
Dental implant suprastructure, temporary, preformed, single-use
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
Supplied sterileEUDAMED
Yes
GUDID
No
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

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

  • Supplied sterile UDI-DI 08800053080910: EUDAMED states Yes, FDA GUDID states No.
  • Sterilise before use UDI-DI 08800053080910: 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, temporary, preformed, single-use

Cleared under the same submission (K111364)

and 8 more cleared under K111364

Similar devices in this category

Other devices filed under DENTAL IMPLANTS.

Other devices from Dentis Co., Ltd

See all devices from Dentis Co., Ltd →

Properties

  • Supplied sterile YesEUDAMEDNoGUDID
  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (18, all answered No)