Sci-Pharm Pit & Fissure Sealer

FDA UDI

Class II (US FDA UDI)

by Scientific Pharmaceuticals, Inc.

Identity

Trade Name: Sci-Pharm Pit & Fissure Sealer 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 FDA UDI
Model / Reference: SP 50-01 FDA UDI
Description: Self-Cured Resin for sealing occlusal fissures and bonding composite restoratives to etched enamel FDA UDI

Identifiers

Catalog Number: 50-01 FDA UDI
Primary DI / UDI-DI: D801SP50011 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

Sci-Pharm Pit & Fissure Sealer by Scientific Pharmaceuticals, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental pit/fissure sealant.

ICE — Sdi , Ltd. · Class II
ICE — Sdi , Ltd. · Class II
Opal Seal — ULTRADENT PRODUCTS, INC. · Class II
PREVENT SEAL — ITENA CLINICAL · Class II
AURA — Sdi , Ltd. · Class II
GLACIER — Sdi , Ltd. · Class II
Seal-Rite™ Low Viscosity — Pulpdent Corporation · Class II
GLACIER — Sdi , Ltd. · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Scientific Pharmaceuticals, Inc.

Sources (1)

FDA UDI fb6fc5f9-3f25-4076-bc67-dd7a61695f50 37 fields · synced May 30, 2026