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Amelogen Plus

FDA UDI

Class II (US FDA UDI)

by Ultradent Products, Inc.

Identity

Trade Name
Amelogen Plus FDA UDI
Generic Name
Dental composite resin FDA UDI
Device Name
Amelogen Plus Syringe Complete Kit FDA UDI
Model / Reference
3254 FDA UDI
Description
Amelogen Plus Syringe Complete Kit FDA UDI

Identifiers

Catalog Number
3254 FDA UDI
Primary DI / UDI-DI
00883205106667 FDA UDI
510(k) Number
K043119 FDA UDI
FDA Product Code
EBF FDA UDI
GMDN Term
Dental composite resin FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3690 FDA UDI
Commercial Distribution
Not 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Amelogen Plus by Ultradent Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K043119 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ultradent Products, Inc.

Sources (1)

  • FDA UDI c35ef2e9-40e8-4fe1-a100-8bc2e1d45d11 38 fields · synced Jun 8, 2026