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SurgiMac 90003-Bx

by Surgimac LLC

SurgiMac 90003-Bx is a Class II device made by Surgimac LLC, listed in FDA GUDID since 7 Jan 2025 (UDI-DI D90003BX50), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD90003BX50 UDI-DI Date7 Jan 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
SurgiMac
Generic name
Dental coating, tooth-desensitizing, professional
Model / reference
90003-Bx
Primary DI / UDI-DI
D90003BX50
FDA product code
LBH
GMDN term
Dental coating, tooth-desensitizing, professional
Device class
Class II
Regulation number
872.3260
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code LBH (Varnish, Cavity).

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Properties

  • Single use
  • Contains latex
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)