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Proform

FDA UDI

Class I (US FDA UDI)

by Keystone Industries

Identity

Trade Name
Proform FDA UDI
Generic Name
Dental appliance fabrication material, thermoplastic FDA UDI
Device Name
.030 S Clear Retainer 25Ea 125mm Round FDA UDI
Model / Reference
9615025R1 FDA UDI
Description
.030 S Clear Retainer 25Ea 125mm Round FDA UDI

Identifiers

Catalog Number
9615025R1 FDA UDI
Primary DI / UDI-DI
H6689615025R11 FDA UDI
FDA Product Code
KMY FDA UDI
GMDN Term
Dental appliance fabrication material, thermoplastic FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.5525 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental appliance fabrication material, thermoplastic

Proform by Keystone Industries — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental appliance fabrication material, thermoplastic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Keystone Industries

Sources (1)

  • FDA UDI 0215d65c-a1f9-4832-984d-3a28ff29741d 36 fields · synced Jun 9, 2026