SciPharm Fluoroseal Cavity Liner

FDA UDI

Class II (US FDA UDI)

by Scientific Pharmaceuticals, Inc.

Identity

Trade Name: SciPharm Fluoroseal Cavity Liner FDA UDI
Generic Name: Dental cavity varnish FDA UDI
Device Name: Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations. Also Provide Protection Against Irritants from Restoratives or Auxiliary Materials. Dentin Shade Syringe. Boxed. Spanish. FDA UDI
Model / Reference: SP 75-035 BS FDA UDI
Description: Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations. Also Provide Protection Against Irritants from Restoratives or Auxiliary Materials. Dentin Shade Syringe. Boxed. Spanish. FDA UDI

Identifiers

Catalog Number: 75-035 FDA UDI
Primary DI / UDI-DI: D801SP75035BS1 FDA UDI
510(k) Number: K860633 FDA UDI
FDA Product Code: LBH FDA UDI
GMDN Term: Dental cavity varnish FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3260 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 cavity varnish

SciPharm Fluoroseal Cavity Liner by Scientific Pharmaceuticals, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental cavity varnish.

NUPRO® — Dentsply Professional · Class II
Fluorodose — CENTRIX, INC. · Class II
NUPRO® — Dentsply Professional · Class II
NUPRO® — Dentsply Professional · Class II
Hydroxyline — Taub Products · Class II
NUPRO® — Dentsply Professional · Class II
NUPRO® — Dentsply Professional · Class II
3M™ — 3M COMPANY · Class II

Cleared under the same submission

K860633 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 3dc4515f-9524-4e42-90ca-7f1f6e9de4e1 37 fields · synced Jun 8, 2026