The Orthodontic Store

FDA UDI

Class I (US FDA UDI)

by Young Innovations, Inc.

Identity

Trade Name: The Orthodontic Store FDA UDI
Generic Name: Dental x-ray film, non-screen FDA UDI
Device Name: PICTURE PERFECT D57 D130 FILM FDA UDI
Model / Reference: PP-I-D57 FDA UDI
Description: PICTURE PERFECT D57 D130 FILM FDA UDI

Identifiers

Catalog Number: PP-I-D57 FDA UDI
Primary DI / UDI-DI: 00840326404010 FDA UDI
FDA Product Code: IWZ FDA UDI
GMDN Term: Dental x-ray film, non-screen FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 892.1840 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

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental x-ray film, non-screen

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

Similar devices

Also classified as Dental x-ray film, non-screen.

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BUTTERFLY BARRIER FILM FSS-58 — Flow X-Ray Corp. · Class I
D-Speed — CARESTREAM HEALTH, INC. · Class II
FILM DSS-58 D ADULT SINGLE FILM BUTTERFLY PACKETS D SPEED — Flow X-Ray Corp. · Class I
Henry Schein — HENRY SCHEIN, INC. · Class I
DV-57 ADULT TWIN VALUE PAK — Flow X-Ray Corp. · Class I
Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
BUTTERFLY BARRIER FILM FSS-54 — Flow X-Ray Corp. · 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 fd157e1b-79d2-4065-b96d-64d6e5003143 35 fields · synced Jun 8, 2026