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Buffalo Dental 1 Sheet Bleach tray EVA

by Buffalo Dental Manufacturing Co., 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 Number00850043381082 UDI-DI Date25 Mar 2026ListedStatusListed 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  • Withdrawn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
Buffalo Dental
Generic Name
Dental appliance fabrication material, thermoplastic
Model / Reference
1 Sheet Bleach tray EVA
Primary DI / UDI-DI
00850043381082
FDA Product Code
EBH
GMDN Term
Dental appliance fabrication material, thermoplastic
Device Class
Class I
Regulation Number
872.3670
GUDID distribution status
In Commercial Distribution

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Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (11)

  • Sterile: 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
  • Manufacturing Date: No