Hygitech Hy-0921

Hygitech Hy-0921 is a Class I device made by Hygitech, listed in FDA GUDID since 16 Dec 2020 (UDI-DI 03615140005135), 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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number03615140005135 UDI-DI	Date16 Dec 2020Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 03615140005135

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: Hygitech
Generic name: Denture repair kit, professional
Model / Ref / Catalog: HY-0921

Primary DI / UDI-DI: 03615140005135
FDA product code: KDD
GMDN term: Denture repair kit, professional

Device class: Class I
Regulation number: 878.4800
GUDID distribution status: In Commercial Distribution

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Properties

Supplied sterile
Single use
Premarket exempt
Lot / batch number
Expiration date
Manufacturing date

Other properties (9, all answered No)