Power Dental USA

FDA UDI

Class I (US FDA UDI)

by Power Dental USA, Inc.

Identity

Trade Name: Power Dental USA FDA UDI
Generic Name: Mouth gag, adjustable, reusable FDA UDI
Device Name: MOUTH GAG PEDO SIZE FDA UDI
Model / Reference: 6427S FDA UDI
Description: MOUTH GAG PEDO SIZE FDA UDI

Identifiers

Catalog Number: 6427S FDA UDI
Primary DI / UDI-DI: D9436427S00 FDA UDI
FDA Product Code: KBN FDA UDI
EIG FDA UDI
GMDN Term: Mouth gag, adjustable, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 874.4420 FDA UDI
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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Hand-held dental retractor Mouth gag, adjustable, reusable Dental cheek retractor, professional, reusable

Power Dental USA by Power Dental USA, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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

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Manufacturer

Manufacturer: Power Dental USA, Inc.

Sources (1)

FDA UDI bc4b3752-50cc-4533-8bbb-aaca03357c32 35 fields · synced May 30, 2026