GoldenDent SM-L

GoldenDent SM-L is a Class I device made by GoldenDent, listed in FDA GUDID since 25 Feb 2021 (UDI-DI 00850028211205), 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	Number00850028211205 UDI-DI	Date25 Feb 2021Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 00850028211205

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: GoldenDent
Generic name: Dental cheek retractor, professional, reusable
Model / Ref / Catalog: SM-L

Primary DI / UDI-DI: 00850028211205
FDA product code: EIG
GMDN term: Dental cheek retractor, professional, reusable

Device class: Class I
Regulation number: 872.4565
GUDID distribution status: In Commercial Distribution

Sterilisation method: High-level Disinfectant

Other devices from GoldenDent

See all devices from GoldenDent →

Properties

Sterilise before use
Premarket exempt
Lot / batch number
Manufacturing date

Other properties (11, all answered No)