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Unitite UCM 4313N

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

Ref UCM 4313NModel DENTAL IMPLANTS WITH HYDROXYAPATITE

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

CE MDR

Valid until

No date given

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 Number999520000002JJ Basic UDI-DI 07899995215734UDI-DIDate18 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07899995215734 UDI-DI Date30 Jun 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  • Withdrawn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
Imp. Unitite Prime CM11.5° Ø4.3x13mm EUDAMED
Unitite GUDID
Generic name
Screw endosteal dental implant, one-piece
Device name
Implant Strong Sw Plus | Implant Unitite | Implant Epikut Plus
Model / Ref / Catalog
UCM 4313N, DENTAL IMPLANTS WITH HYDROXYAPATITE
Primary DI / UDI-DI
07899995215734
Basic UDI-DI
999520000002JJ
510(k) Number
FDA product code
DZE
EMDN code
P01020101 Dental implants
GMDN term
Screw endosteal dental implant, one-piece
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.3640
EU registration type
Standard device
EU market of registration
Portugal
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Screw endosteal dental implant, one-piece

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

  • Supplied sterile
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date

Other properties (17)

  • Sterilise before use: 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