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Enamelize

FDA UDI

Class I (US FDA UDI)

by Cosmedent, Inc.

Identity

Trade Name
Enamelize FDA UDI
Generic Name
Professional dental abrasive material FDA UDI
Model / Reference
906000 FDA UDI

Identifiers

Catalog Number
906000 FDA UDI
Primary DI / UDI-DI
D7799060000 FDA UDI
510(k) Number
K862912 FDA UDI
FDA Product Code
EJR FDA UDI
GMDN Term
Professional dental abrasive material FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.6030 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Professional dental abrasive material

Enamelize by Cosmedent, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Professional dental abrasive material.

Cleared under the same submission

K862912 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cosmedent, Inc.

Sources (1)

  • FDA UDI aa283c5c-66f2-4c0a-8063-e152ebda69e3 34 fields · synced May 31, 2026