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Trephine Bur TB5545L

by InnoBioSurg Co., Ltd(IBS implant Co., Ltd) GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08809986620446 UDI-DIDate6 Mar 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Trephine Bur
Generic Name
Fixture/appliance dental drill bit, reusable
Model / Reference
TB5545L
Primary DI / UDI-DI
08809986620446
FDA Product Code
DZA
GMDN Term
Fixture/appliance dental drill bit, reusable
Device Class
Class I
Regulation Number
872.4130
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Safe

Other devices from InnoBioSurg Co., Ltd(IBS implant Co., Ltd)

See all devices from InnoBioSurg Co., Ltd(IBS implant Co., Ltd) →

Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (9)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Expiration Date: No