Skip to content

Screw Laboratory Sw Cm Ptl 16

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

Ref PTL 16Model LABORATORY DEVICE - CLASS I

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number999520000048KA Basic UDI-DI 07899995212245UDI-DIDate13 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07899995212245 UDI-DI Date21 Jul 2023ListedStatusListed 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.

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  • Withdrawn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
Screw Lab. MT16° EUDAMED
Screw Laboratory Sw Cm GUDID
Generic Name
Dental prosthesis/implant abutment screw analog, single-use
Device Name
Screw Laboratory
Model / Reference
PTL 16, LABORATORY DEVICE - CLASS I
Primary DI / UDI-DI
07899995212245
Basic UDI-DI
999520000048KA
FDA Product Code
NDP
EMDN Code
P010299 Odontological prostheses - other
GMDN Term
Dental prosthesis/implant abutment screw analog, single-use
Device Class
Class I
Regulation Number
872.3980
EU market of registration
Portugal
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Dental prosthesis/implant abutment screw analog, single-use

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

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • Sterile: No
  • Implantable: No
  • 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