Cleared Traditional

K982915 - SCI-PHARM DFV VARNISH

K982915 is the FDA 510(k) clearance for SCI-PHARM DFV VARNISH by Scientific Pharmaceuticals, Inc.. It is a Class 2 Dental device (product code LBH) cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K982915 · Scientific Pharmaceuticals, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
177d
Days
Class 2
Risk

K982915 is an FDA 510(k) clearance for the SCI-PHARM DFV VARNISH. Classified as Varnish, Cavity (product code LBH), Class II - Special Controls.

Submitted by Scientific Pharmaceuticals, Inc. (Pomona, US). The FDA issued a Cleared decision on February 12, 1999 after a review of 177 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3260 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Scientific Pharmaceuticals, Inc. devices

Submission Details

510(k) Number K982915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1998
Decision Date February 12, 1999
Days to Decision 177 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 127d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LBH Varnish, Cavity
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3260
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - LBH Varnish, Cavity

All 78
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K982915.
PULPDENT CAVITY PREPARATION 1, PULPDENT CAVITY PREPARATION 1 WITH FLUORIDE
K994182 · Pulpdent Corp. · Feb 2000
SEAL & PROTECT PROTECTIVE SEALANT FOR EXPOSED DENTINE
K992822 · Dentsply Intl. · Nov 1999
D/SENSE II (GREEN-OR) DENTIN DESENSITIZER
K992629 · Centrix, Inc. · Oct 1999
SCI-PHARM DESENSITIZING VARNISH
K983305 · Scientific Pharmaceuticals, Inc. · Dec 1998
GREEN-OR DENTIN DESENSITIZER
K981972 · Centrix, Inc. · Dec 1998
PULPDENT CAVITY CLEANSER, PULPDENT CAVITY CLEANSER PLUS
K974202 · Pulpdent Corp. · Mar 1998