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Insert tool for PSD

by Implant Protesis Dental 2004 S.L.

Part of a family of 68 devices: see the family page

Ref IPD/LL-PS-01Model LL

Insert tool for PSD (IPD/LL-PS-01) is a Class I device made by Implant Protesis Dental 2004 S.L., registered in EUDAMED on 17 Jan 2023 (Basic UDI-DI 8435566622BU) and listed in FDA GUDID since 13 Jun 2023 (UDI-DI 08435566618192), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08435566618192 UDI-DI Date13 Jun 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number8435566622BU Basic UDI-DI 08435566618192UDI-DIDate17 Jan 2023RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 8435566622BU registered 17 Jan 2023 Active
  • FDA GUDID UDI-DI 08435566618192 listed 13 Jun 2023 Listed

Timeline

2 dated events

  1. Registered EUDAMED 8435566622BU
  2. Listed FDA GUDID 08435566618192

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  • Withdrawn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
Insert tool for PSD EUDAMED
Ipd GUDID
Generic name
Surgical screwdriver, reusable
Device name
Screwdriver
Model / Ref / Catalog
LL, IPD/LL-PS-01
Primary DI / UDI-DI
08435566618192
Basic UDI-DI
8435566622BU
FDA product code
NDP
EMDN code
Q010280 Prosthetic dentistry devices - accessories
GMDN term
Surgical screwdriver, reusable
Device class
Class I
Regulation number
872.3980
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
ES-MF-000002195

Similar devices in this category

Other devices filed under PROSTHETIC DENTISTRY DEVICES - ACCESSORIES.

Other devices from Implant Protesis Dental 2004 S.L.

See all devices from Implant Protesis Dental 2004 S.L. →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)