ProSeal

FDA UDI

Class II (US FDA UDI)

by Reliance Orthodontic Products, Inc.

Identity

Trade Name: ProSeal FDA UDI
Generic Name: Dental pit/fissure sealant FDA UDI
Device Name: PRO SEAL® and LED PRO SEAL® are intended for use as an enamel surface sealant around orthodontic brackets. 6ml bottle ProSeal FDA UDI
Model / Reference: PRO FDA UDI
Description: PRO SEAL® and LED PRO SEAL® are intended for use as an enamel surface sealant around orthodontic brackets. 6ml bottle ProSeal FDA UDI

Identifiers

Catalog Number: PRO FDA UDI
Primary DI / UDI-DI: D798PRO0 FDA UDI
510(k) Number: K021503 FDA UDI
FDA Product Code: EBD FDA UDI
GMDN Term: Dental pit/fissure sealant FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3310 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

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

ProSeal by Reliance Orthodontic Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental pit/fissure sealant.

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ICE — Sdi , Ltd. · Class II
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AURA — Sdi , Ltd. · Class II
GLACIER — Sdi , Ltd. · Class II
SciPharm Pit & Fissure Sealer Bonding Agent — SCIENTIFIC PHARMACEUTICALS, INC. · Class II
Seal-Rite™ Low Viscosity — Pulpdent Corporation · Class II

Cleared under the same submission

K021503 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: Reliance Orthodontic Products, Inc.

Sources (1)

FDA UDI 21a06a9d-e546-4b21-9dfd-ab46e7596b55 37 fields · synced Jun 6, 2026