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Instrument Frctv 38

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

Part of a family of 196 devices: see the family page

Ref FRCTV 38Model DRILLS WITH DLC

Instrument Frctv 38 is a device classified as Class IIa in the EU and Class I in the US made by S.I.N. - Sistema DE Implante Nacional S.A., registered in EUDAMED on 30 May 2026 (Basic UDI-DI 999520000070K3) and listed in FDA GUDID since 15 Aug 2025 (UDI-DI 07899995239259), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number999520000070K3 Basic UDI-DI 07899995239259UDI-DIDate30 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07899995239259 UDI-DI Date15 Aug 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 999520000070K3 registered 30 May 2026 Active
  • FDA GUDID UDI-DI 07899995239259 listed 15 Aug 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07899995239259
  2. Registered EUDAMED 999520000070K3

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  • Withdrawn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
Drill Countersink Ø3.8mm EUDAMED
Instrument GUDID
Generic name
Fixture/appliance dental drill bit, reusable
Device name
Drills
Model / reference
FRCTV 38, DRILLS WITH DLC
Primary DI / UDI-DI
07899995239259
Basic UDI-DI
999520000070K3
FDA product code
NDP
EMDN code
L159099 Odontostomatology instruments, reusable - other
GMDN term
Fixture/appliance dental drill bit, reusable
Device class
Class IIa EUDAMED
Class I GUDID
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
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Fixture/appliance dental drill bit, reusable

Similar devices in this category

Other devices filed under ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - 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
  • Reusable
  • Reprocessed single-use device
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)