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Provisional Abutment CPTM 3503-H

by S.I.N. - Sistema DE Implante Nacional S.A.

Ref CPTM 3503-HModel NON-STERILE COMPONENTS TEMPORARY ABUTMENT

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K170392

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number999520000007JU Basic UDI-DI 07899995206992UDI-DIDate20 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07899995206992 UDI-DI Date30 Jun 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK170392 Date1 Dec 2017DecidedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Temporary Cylinder MT16° Ø3.5x3mm EUDAMED
Provisional Abutment GUDID
Generic name
Dental implant suprastructure, temporary, preformed, single-use
Device name
Temporary Cylinder
Model / Ref / Catalog
CPTM 3503-H, NON-STERILE COMPONENTS TEMPORARY ABUTMENT
Primary DI / UDI-DI
07899995206992
Basic UDI-DI
999520000007JU
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
Standard device
EU market of registration
Portugal
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

Related devices

Category: Dental implant suprastructure, temporary, preformed, single-use

Cleared under the same submission (K170392)

Show all (12)

Other devices from S.I.N. - Sistema DE Implante Nacional S.A.

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Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date

Other properties (18)

  • Supplied sterile: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Expiration date: No