← Back to catalogue

Ambar Universal APS

FDA UDI

Class II (US FDA UDI)

by Dentscare Ltda

Identity

Trade Name
Ambar Universal APS FDA UDI
Generic Name
Dentine bonding agent/set FDA UDI
Device Name
Ambar Universal APS is a single flask self-etch light-curing adhesive system (Seventh Generation) responsible for the union between tooth structure (enamel and dentin) and restorative materials. FDA UDI
Model / Reference
5mL FDA UDI
Description
Ambar Universal APS is a single flask self-etch light-curing adhesive system (Seventh Generation) responsible for the union between tooth structure (enamel and dentin) and restorative materials. FDA UDI

Identifiers

Catalog Number
4000019361 FDA UDI
Primary DI / UDI-DI
07899633815944 FDA UDI
FDA Product Code
KLE FDA UDI
GMDN Term
Dentine bonding agent/set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3200 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

Yes

FDA UDI

Category: Dentine bonding agent/set

Ambar Universal APS by Dentscare Ltda — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dentine bonding agent/set.

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
Dentscare Ltda

Sources (1)

  • FDA UDI b7ebeac1-f381-44df-bc6e-7d62f8c671b3 34 fields · synced May 30, 2026