Champ

FDA UDI

Class II (US FDA UDI)

by Centrix, Inc.

Identity

Trade Name: Champ FDA UDI
Generic Name: Dental unfilled resin sealant/coating FDA UDI
Device Name: Champ Pit & Fissure Sealant, 64 pk FDA UDI
Model / Reference: 360120 FDA UDI
Description: Champ Pit & Fissure Sealant, 64 pk FDA UDI

Identifiers

Primary DI / UDI-DI: 00817051020341 FDA UDI
FDA Product Code: EBF FDA UDI
EBC FDA UDI
GMDN Term: Dental unfilled resin sealant/coating FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3690 FDA UDI
872.3765 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

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

Yes

FDA UDI

Category: Dental unfilled resin sealant/coating

Champ by Centrix, Inc. — 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
OptiGuard — KERR CORPORATION · Class II
OPTIGLAZE™ — Gc America Inc. · Class II
RE-GEN Pit & Fissure Sealant — Vista Dental · 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: Centrix, Inc.

Sources (1)

FDA UDI 9085a778-98d0-49c6-850e-d9a447e1a46e 33 fields · synced May 30, 2026