GoldenDent

FDA UDI

Class I (US FDA UDI)

by GoldenDent

Identity

Trade Name: GoldenDent FDA UDI
Generic Name: Dental cheek retractor, professional, reusable FDA UDI
Device Name: SeeMore Lip, Check and Tongue Retractor Large FDA UDI
Model / Reference: SM-L FDA UDI
Description: SeeMore Lip, Check and Tongue Retractor Large FDA UDI

Identifiers

Catalog Number: SM-L FDA UDI
Primary DI / UDI-DI: 00850028211205 FDA UDI
FDA Product Code: EIG FDA UDI
GMDN Term: Dental cheek retractor, professional, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

High-level Disinfectant FDA UDI

Category: Dental cheek retractor, professional, reusable

GoldenDent by GoldenDent — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental cheek retractor, professional, reusable.

Power Dental USA — Power Dental USA, Inc. · Class I
RETRACTOR MOZSARY — W.H. Holden, Inc. · Class I
RETRACTOR APFEL — W.H. Holden, Inc. · Class I
STERLING — BENCO DENTAL SUPPLY CO. · Class I
Extraoral Cheek Retractors — ORTHO TECHNOLOGY, INC. · Class I
Extraoral Cheek Retractors — ORTHO TECHNOLOGY, INC. · Class I
Power Dental USA — Power Dental USA, Inc. · Class I
Power Dental USA — Power Dental USA, Inc. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: GoldenDent

Sources (1)

FDA UDI 92b439f3-d418-4019-a488-8758854b02fc 34 fields · synced May 30, 2026