Embrace Wetbond Low Fill

FDA UDI

Class II (US FDA UDI)

by Pulpdent Corporation

Identity

Trade Name: Embrace Wetbond Low Fill FDA UDI
Generic Name: Dental pit/fissure sealant FDA UDI
Device Name: Kit: 4 x 1.2 mL syringes Low Fill sealant, off-white shade 7.9% filled FDA UDI
Model / Reference: EMSWLF FDA UDI
Description: Kit: 4 x 1.2 mL syringes Low Fill sealant, off-white shade 7.9% filled FDA UDI

Identifiers

Primary DI / UDI-DI: D701EMSWLF2 FDA UDI
FDA Product Code: EBC FDA UDI
GMDN Term: Dental pit/fissure sealant FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3765 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

Category: Dental pit/fissure sealant

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

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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 3d39d7a9-9bbd-4344-bee8-54e331a933c7 33 fields · synced Jun 9, 2026