← Back to catalogue

Pearson

FDA UDI

Class U (US FDA UDI)

by Keystone Industries

Identity

Trade Name
Pearson FDA UDI
Generic Name
Dental appliance fabrication material, thermoplastic FDA UDI
Device Name
Pearson .060 Mouthguard Clear 12Pk FDA UDI
Model / Reference
7000944 FDA UDI
Description
Pearson .060 Mouthguard Clear 12Pk FDA UDI

Identifiers

Catalog Number
7000944 FDA UDI
Primary DI / UDI-DI
H668D6400241 FDA UDI
FDA Product Code
MQC FDA UDI
EBH FDA UDI
GMDN Term
Dental appliance fabrication material, thermoplastic FDA UDI

Classification

Device Class
U FDA UDI
Regulation Number
872.3670 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

Pearson by Keystone Industries — Class U — 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

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

Manufacturer

Manufacturer
Keystone Industries

Sources (1)

  • FDA UDI 9a0e1548-1b58-4a72-af2c-6fbb9cb8fb3d 36 fields · synced Jun 9, 2026