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SciPharm Pit & Fissure Sealer Bonding Agent, Part A

FDA UDI

Class II (US FDA UDI)

by Scientific Pharmaceuticals, Inc.

Identity

Trade Name
SciPharm Pit & Fissure Sealer Bonding Agent, Part A FDA UDI
Generic Name
Dental pit/fissure sealant FDA UDI
Device Name
Self-cured Resin for sealing occlusal fissures and bonding composite. Non-Boxed FDA UDI
Model / Reference
SP 50-116 N FDA UDI
Description
Self-cured Resin for sealing occlusal fissures and bonding composite. Non-Boxed FDA UDI

Identifiers

Catalog Number
50-116 FDA UDI
Primary DI / UDI-DI
D801SP50116N1 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental pit/fissure sealant

SciPharm Pit & Fissure Sealer Bonding Agent, Part A by Scientific Pharmaceuticals, Inc. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Dental pit/fissure sealant.

Cleared under the same submission

K790788 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Scientific Pharmaceuticals, Inc.

Sources (1)

  • FDA UDI ad0dee6a-d510-4143-b855-99d9806a70cc 37 fields · synced May 30, 2026