Embrace Wetbond Seal-N-Shine

FDA UDI

Class II (US FDA UDI)

by Pulpdent Corporation

Identity

Trade Name: EMBRACE WETBOND SEAL-N-SHINE FDA UDI
Generic Name: Dental unfilled resin sealant/coating FDA UDI
Device Name: 6 mL bottle, clear shade, brush handle, 100 brush tips Penetrating Finish and Polishing Resin, Light Cure FDA UDI
Model / Reference: EMSNS FDA UDI
Description: 6 mL bottle, clear shade, brush handle, 100 brush tips Penetrating Finish and Polishing Resin, Light Cure FDA UDI

Identifiers

Primary DI / UDI-DI: D701EMSNS2 FDA UDI
510(k) Number: K020432 FDA UDI
FDA Product Code: KLE FDA UDI
EBF FDA UDI
GMDN Term: Dental unfilled resin sealant/coating FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3200 FDA UDI
872.3690 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: Total Volume — 6 Milliliter FDA UDI

Category: Dental unfilled resin sealant/coating

Embrace Wetbond Seal-N-Shine by Pulpdent Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental unfilled resin sealant/coating.

UltraSeal XT Hydro — ULTRADENT PRODUCTS, INC. · Class II
UltraSeal XT Plus — ULTRADENT PRODUCTS, INC. · Class II
ResinBlend LV Composite Blending Resin — Den-Mat Holdings, LLC · Class II
Ribbon — TULSA DENTAL PRODUCTS LLC · Class II
UltraSeal XT Hydro — ULTRADENT PRODUCTS, INC. · Class II
Champ — CENTRIX, INC. · Class II
OptiGuard — KERR CORPORATION · Class II
OPTIGLAZE™ — Gc America Inc. · Class II

Cleared under the same submission

K020432 also covers:

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 30f67a3a-a582-4e78-9191-0d9ff2894695 35 fields · synced Jun 9, 2026