SciPharm Pit & Fissure Sealer Bonding Agent

FDA UDI

Class II (US FDA UDI)

by Scientific Pharmaceuticals, Inc.

Identity

Trade Name: SciPharm Pit & Fissure Sealer Bonding Agent FDA UDI
Generic Name: Dental pit/fissure sealant FDA UDI
Device Name: Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etched Enamel. Clear, Untinted. Spanish FDA UDI
Model / Reference: SP 51-01 S FDA UDI
Description: Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etched Enamel. Clear, Untinted. Spanish FDA UDI

Identifiers

Catalog Number: 51-01 FDA UDI
Primary DI / UDI-DI: D801SP5101S1 FDA UDI
510(k) Number: K790788 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

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 pit/fissure sealant

SciPharm Pit & Fissure Sealer Bonding Agent by Scientific Pharmaceuticals, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K790788 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: Scientific Pharmaceuticals, Inc.

Sources (1)

FDA UDI 55d55c00-057a-419a-a71e-6116ba084574 37 fields · synced Jun 8, 2026