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Plastic Abutment CPM 4800-3

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

Ref CPM 4800-3Model PROSTHETIC COMPONENT - NON-STERILE LABORATORY DEVICE PLASTIC ABUTMENT

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number999520000016JV Basic UDI-DI 07899995206763UDI-DIDate8 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07899995206763 UDI-DI Date1 Jul 2022ListedStatusListed GUDID: in commercial distribution

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 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Cilinder Cast. Mini Abut. C/ Prh 30 EUDAMED
Plastic Abutment GUDID
Generic Name
Dental implant suprastructure, permanent, preformed
Model / Ref / Catalog
CPM 4800-3, PROSTHETIC COMPONENT - NON-STERILE LABORATORY DEVICE PLASTIC ABUTMENT
Primary DI / UDI-DI
07899995206763
Basic UDI-DI
999520000016JV
510(k) Number
FDA Product Code
NHA
EMDN Code
P010299 Odontological prostheses - other
GMDN Term
Dental implant suprastructure, permanent, preformed
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
872.3630
EU market of registration
Portugal
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II
ImplantableEUDAMED
No
GUDID
Yes

Related devices

Category: Dental implant suprastructure, permanent, preformed

Cleared under the same submission (K051859)

Show all (12)

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

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Properties

  • Single Use
  • Implantable NoEUDAMEDYesGUDID
  • Reusable
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (17)

  • Sterile: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No