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DentaSwiss GS-36ZMR53

by Biodenta Swiss AG

DentaSwiss GS-36ZMR53 is a Class I device made by Biodenta Swiss AG, listed in FDA GUDID since 30 Aug 2024 (UDI-DI 07640169735127), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07640169735127 UDI-DI Date30 Aug 2024ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
DentaSwiss
Generic name
Surgical drill guide, single-use
Model / reference
GS-36ZMR53
Primary DI / UDI-DI
07640169735127
FDA product code
NDP
GMDN term
Surgical drill guide, single-use
Device class
Class I
Regulation number
872.3980
GUDID distribution status
In Commercial Distribution

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Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)