Cleared Traditional

K982915 - SCI-PHARM DFV VARNISH

K982915 is an FDA 510(k) clearance for SCI-PHARM DFV VARNISH, manufactured by Scientific Pharmaceuticals, Inc.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K982915

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.

LBH Device Classification - Class 2, Special Controls

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 107
Devices cleared under the same product code (LBH) and FDA review panel - the closest regulatory comparables to K982915.
HEMASEAL & CIDE
K990779 · Advantage Dental Products, Inc. · Nov 1999
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