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Screw Laboratory Ptmal 01

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

Part of a family of 18 devices: see the family page

Ref PTMAL 01Model LABORATORY DEVICE - CLASS I

Screw Laboratory Ptmal 01 is a Class I device made by S.I.N. - Sistema DE Implante Nacional S.A., registered in EUDAMED on 13 Aug 2026 (Basic UDI-DI 999520000048KA) and listed in FDA GUDID since 21 Jul 2023 (UDI-DI 07899995278333), active as of 24 Oct 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number999520000048KA Basic UDI-DI 07899995278333UDI-DIDate13 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07899995278333 UDI-DI Date21 Jul 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 999520000048KA registered 13 Aug 2026 Active
  • FDA GUDID UDI-DI 07899995278333 listed 21 Jul 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07899995278333
  2. Registered EUDAMED 999520000048KA

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  • Withdrawn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.abut.mult.f/ Transfer.tray Op. EUDAMED
Screw Laboratory GUDID
Generic name
Dental prosthesis/implant abutment screw analog, single-use
Model / reference
PTMAL 01, LABORATORY DEVICE - CLASS I
Primary DI / UDI-DI
07899995278333
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 registration type
Standard device
EU market of registration
Portugal
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 07899995278333: EUDAMED states No, FDA GUDID states Yes.

Related devices

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

Similar devices in this category

Other devices filed under ODONTOLOGICAL PROSTHESES - OTHER.

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

  • Sterilise before use NoEUDAMEDYesGUDID
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)