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Abutment Screw PT 16

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

Part of a family of 67 devices: see the family page

Ref PT 16Model STERILE COMPONENTS

Abutment Screw PT 16 is a device classified as Class IIb in the EU and Class II in the US made by S.I.N. - Sistema DE Implante Nacional S.A., registered in EUDAMED on 20 Aug 2026 (Basic UDI-DI 999520000006JS), cleared under FDA 510(k) K170392 on 1 Dec 2017 and listed in FDA GUDID since 1 Mar 2021 (UDI-DI 07899995212184), active as of 7 Nov 2026.

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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K170392

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number999520000006JS Basic UDI-DI 07899995212184UDI-DIDate20 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07899995212184 UDI-DI Date1 Mar 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK170392 Date1 Dec 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 999520000006JS registered 20 Aug 2026 Active
  • FDA 510(k) K170392 decided 1 Dec 2017 Active
  • FDA GUDID UDI-DI 07899995212184 listed 1 Mar 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K170392
  2. Listed FDA GUDID 07899995212184
  3. Registered EUDAMED 999520000006JS

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  • Withdrawn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
Fixation Screw MT16° EUDAMED
Abutment Screw GUDID
Generic name
Dental prosthesis/implant abutment screw
Device name
Abutment Acessories Screw
Model / Ref / Catalog
PT 16, STERILE COMPONENTS
Primary DI / UDI-DI
07899995212184
Basic UDI-DI
999520000006JS
510(k) Number
FDA product code
NHA
EMDN code
P01020101 Dental implants
GMDN term
Dental prosthesis/implant abutment screw
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

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

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 prosthesis/implant abutment screw

Cleared under the same submission (K170392)

and 8 more cleared under K170392

Similar devices in this category

Other devices filed under DENTAL IMPLANTS.

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

See all devices from S.I.N. - Sistema DE Implante Nacional S.A. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Sutures
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)