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One Gloss PS Sample Pack

FDA UDI

Class I (US FDA UDI)

by Shofu Dental Corp.

Identity

Trade Name
One Gloss PS Sample Pack FDA UDI
Generic Name
Dental polishing cup, single-use FDA UDI
Device Name
Contains DIs: E23501770; E23501760; E23501780 FDA UDI
Model / Reference
001 FDA UDI
Description
Contains DIs: E23501770; E23501760; E23501780 FDA UDI

Identifiers

Catalog Number
OGPS/SAMPLE FDA UDI
Primary DI / UDI-DI
E235OGPSSAMPLE0 FDA UDI
FDA Product Code
EHL FDA UDI
GMDN Term
Dental polishing cup, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.6010 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dental polishing cup, single-use

One Gloss PS Sample Pack by Shofu Dental Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental polishing cup, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shofu Dental Corp.

Sources (1)

  • FDA UDI 87cef698-c9e5-4ed7-94c7-a95b466893f9 36 fields · synced May 30, 2026