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Single-Use Guiding Instruments

by B.T.I. Biotechnology Institute, S.l 2 variants

Ref S3CG

Single-Use Guiding Instruments (S3CG) is a Class I device made by B.T.I. Biotechnology Institute, S.l, registered in EUDAMED on 2 Jul 2025 (Basic UDI-DI 84353898SINGLE-GUIDEFG) and listed in FDA GUDID since 15 Apr 2025 (UDI-DI 08435389828174), 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
European UnionCE/MDR EUDAMED Number84353898SINGLE-GUIDEFG Basic UDI-DI 08435389828174UDI-DIDate2 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08435389828174 UDI-DI Date15 Apr 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 84353898SINGLE-GUIDEFG registered 2 Jul 2025 Active
  • FDA GUDID UDI-DI 08435389828174 listed 15 Apr 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08435389828174
  2. Registered EUDAMED 84353898SINGLE-GUIDEFG

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  • Withdrawn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
Interna 3.0 Surgical Guide Sleeve Bti
Generic name
Dental implantation drilling template guide-sleeve
Device name
Single-Use Guiding Instruments
Model / reference
S3CG
Primary DI / UDI-DI
08435389828174
Basic UDI-DI
84353898SINGLE-GUIDEFG
FDA product code
NDP
EMDN code
Q010599 Dental instruments, single-use - other
GMDN term
Dental implantation drilling template guide-sleeve
Device class
Class I
Regulation number
872.3980
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
ES-MF-000001701

Similar devices in this category

Other devices filed under DENTAL INSTRUMENTS, SINGLE-USE - OTHER.

Other devices from B.T.I. Biotechnology Institute, S.l

See all devices from B.T.I. Biotechnology Institute, S.l →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)