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Strong SW Plus SWCM 3510N

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

Active European Union

Ref SWCM 3510NModel DENTAL IMPLANTS WITH HYDROXYAPATITE

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number999520000002JJ Basic UDI-DIDate18 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07899995271860 UDI-DIDate29 Jun 2022ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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 on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Imp. Strong Sw Plus MT16° Ø3.5x10mm EUDAMED
Strong SW Plus GUDID
Generic Name
Screw endosteal dental implant, one-piece
Device Name
Implant Strong Sw Plus | Implant Unitite | Implant Epikut Plus
Model / Ref / Catalog
SWCM 3510N, DENTAL IMPLANTS WITH HYDROXYAPATITE
Primary DI / UDI-DI
07899995271860
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
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 (K193096)

Show all (12)

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Sutures
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (16)

  • Reusable: 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