Skip to content

Prosthetic Kit 1 KP1

by Biotechnology Institute Sl

Ref KP1

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number84353898SURGICAL-BOX-C1DN Basic UDI-DI 08435389805571UDI-DIDate17 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08435389805571 UDI-DI Date9 Jun 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  • Withdrawn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
Prosthetic Kit 1
Generic Name
Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Device Name
Surgical Instruments Kits
Model / Reference
KP1
Primary DI / UDI-DI
08435389805571
Basic UDI-DI
84353898SURGICAL-BOX-C1DN
FDA Product Code
OFY
EMDN Code
L159016 Dental surgery instrument kits, reusable
GMDN Term
Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Device Class
Class I
Regulation Number
872.3980
Medical Purpose
Surgical Instrument Kits intended to support surgical, prosthetic, and regenerative procedures
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable

Other devices from Biotechnology Institute Sl

See all devices from Biotechnology Institute Sl →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No