Young Specialties

FDA UDI

Class I (US FDA UDI)

by Young Innovations, Inc.

Identity

Trade Name: Young Specialties FDA UDI
Generic Name: Dental cheek retractor, professional, reusable FDA UDI
Device Name: Cheek-X-Pander, Large FDA UDI
Model / Reference: 615-800 FDA UDI
Description: Cheek-X-Pander, Large FDA UDI

Identifiers

Catalog Number: 615-800 FDA UDI
Primary DI / UDI-DI: 00843471144848 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

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

Moist Heat or Steam Sterilization FDA UDI

Category: Dental cheek retractor, professional, reusable

Young Specialties by Young Innovations, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental cheek retractor, professional, reusable.

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RETRACTOR APFEL — W.H. Holden, Inc. · Class I
STERLING — BENCO DENTAL SUPPLY CO. · Class I
GoldenDent — GoldenDent · 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

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: Young Innovations, Inc.

Sources (1)

FDA UDI b077ddcc-1ed7-43b6-8312-159a871f17e2 35 fields · synced Jun 8, 2026