Embrace Wetbond Resin Cement

FDA UDI

Class II (US FDA UDI)

by Pulpdent Corporation

Identity

Trade Name: EMBRACE WETBOND RESIN CEMENT FDA UDI
Generic Name: Dental composite resin FDA UDI
Device Name: Low Viscosity Automix Syringe Refill: 3.5 gm cement, 10 automix tips Dual Cure, Fluoride Releasing, Radiopaque FDA UDI
Model / Reference: EMCAR2 FDA UDI
Description: Low Viscosity Automix Syringe Refill: 3.5 gm cement, 10 automix tips Dual Cure, Fluoride Releasing, Radiopaque FDA UDI

Identifiers

Primary DI / UDI-DI: D701EMCAR22 FDA UDI
FDA Product Code: EMA FDA UDI
GMDN Term: Dental composite resin FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3275 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Weight — 3.5 Gram FDA UDI

Category: Dental composite resin

Embrace Wetbond Resin Cement by Pulpdent Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Llis — Dentscare Ltda · Class II
Capo Universal, 6 g — Schütz Dental GmbH · Class II
OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Pulpdent Corporation

Sources (1)

FDA UDI 33f14549-3dc8-44d2-8b5e-ed536e7d2e9a 34 fields · synced Jun 9, 2026