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Hex Grooved Kls Osteotome Epker, Straight, 4mm, 18cm 91-9604

by W.H. Holden, Inc.

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD9289196040 UDI-DI Date14 Aug 2024ListedStatusListed 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  • Withdrawn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
Hex Grooved Kls Osteotome Epker, Straight, 4mm, 18cm
Generic Name
Dental osteotome
Model / Ref / Catalog
91-9604
Primary DI / UDI-DI
D9289196040
FDA Product Code
GFI
GMDN Term
Dental osteotome
Device Class
Class I
Regulation Number
878.4800
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Dental osteotome

Other devices from W.H. Holden, Inc.

See all devices from W.H. Holden, Inc. →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

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