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Nobel Biocare® 35425

by Nobel Biocare AG

Nobel Biocare® 35425 is a Class I device made by Nobel Biocare AG, listed in FDA GUDID since 17 Sep 2016 (UDI-DI 07332747014242), 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 Number07332747014242 UDI-DI Date17 Sep 2016ListedStatusListed 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  • Withdrawn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
Nobel Biocare®
Generic name
Fluted surgical drill bit, single-use
Model / Ref / Catalog
35425
Primary DI / UDI-DI
07332747014242
FDA product code
NDP
GMDN term
Fluted surgical drill bit, single-use
Device class
Class I
Regulation number
872.3980
GUDID distribution status
In Commercial Distribution
Size
Length — 15.000 Millimeter

Related devices

Category: Fluted surgical drill bit, single-use

Similar devices in this category

Other devices filed under Fluted surgical drill bit, single-use.

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)