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Onegloss

FDA UDI

Class I (US FDA UDI)

by Shofu Dental Corp.

Identity

Trade Name
ONEGLOSS FDA UDI
Generic Name
Dental polishing cup, single-use FDA UDI
Device Name
ONEGLOSS MINI REFILL FDA UDI
Model / Reference
0186 FDA UDI
Description
ONEGLOSS MINI REFILL FDA UDI

Identifiers

Catalog Number
0186 FDA UDI
Primary DI / UDI-DI
E23501860 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

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

No

FDA UDI

Category: Dental polishing cup, single-use

Onegloss 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 0bbe5694-533b-4360-bcba-9864e040803c 35 fields · synced Jun 8, 2026