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Hygenic H00560

by Coltene/Whaledent Inc.

Hygenic H00560 is a rubber dam frame (FDA Class I; FDA product code EJE, Frame, Rubber Dam) made by Coltene/Whaledent Inc., listed in FDA GUDID since 27 Feb 2019 (UDI-DI D661H005600), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD661H005600 UDI-DI Date27 Feb 2019ListedStatusListed 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  • Withdrawn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
Hygenic
Generic name
Rubber dam frame
Model / reference
H00560
Primary DI / UDI-DI
D661H005600
FDA product code
EJE
GMDN term
Rubber dam frame
Device class
Class I
Regulation number
872.6300
GUDID distribution status
In Commercial Distribution

Related devices

Category: Rubber dam frame

Similar devices

Other devices filed under FDA product code EJE (Frame, Rubber Dam).

Other devices from Coltene/Whaledent Inc.

See all devices from Coltene/Whaledent Inc. →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (12, all answered No)