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Hygienic Sleeves 3D Bite Block

by Carestream Dental LLC

Hygienic Sleeves 3D Bite Block (BDA16) is a Class I device made by Carestream Dental LLC, listed in FDA GUDID since 15 Jan 2018 (UDI-DI 60192155008184), registry data as of 19 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 19 Oct 2026.

Regulatory status

as of registry sync 19 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number60192155008184 UDI-DI Date15 Jan 2018ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic name
Cable/lead/sensor/probe cover, sterile
Model / Ref / Catalog
Hygienic Sleeves 3D Bite Block, BDA16
Primary DI / UDI-DI
60192155008184
FDA product code
KQM
GMDN term
Cable/lead/sensor/probe cover, sterile
Device class
Class I
Regulation number
878.4160
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cable/lead/sensor/probe cover, sterile

Other devices from Carestream Dental LLC

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Properties

  • Single use
  • Premarket exempt
  • Serial number
Other properties (12, all answered No)