Skip to content

EZ Bite block BB-3000M

by Dxm Co., Ltd

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800017901817 UDI-DI Date16 Dec 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  • Withdrawn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
EZ Bite block
Generic Name
Dental suction protective mouthpiece
Model / Reference
BB-3000M
Primary DI / UDI-DI
08800017901817
FDA Product Code
BRW
GMDN Term
Dental suction protective mouthpiece
Device Class
Class I
Regulation Number
868.5820
GUDID distribution status
In Commercial Distribution

Other devices from Dxm Co., Ltd

See all devices from Dxm Co., Ltd →

Properties

  • Single Use

Other properties (13)

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