Cleared Traditional

K800439 - ADR COMPOSITE RESTORATIVE

K800439 is the FDA 510(k) clearance for ADR COMPOSITE RESTORATIVE by Scientific Pharmaceuticals, Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K800439 · Scientific Pharmaceuticals, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1980
Decision
13d
Days
Class 2
Risk

K800439 is an FDA 510(k) clearance for the ADR COMPOSITE RESTORATIVE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Scientific Pharmaceuticals, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 12, 1980 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Scientific Pharmaceuticals, Inc. devices

Submission Details

510(k) Number K800439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1980
Decision Date March 12, 1980
Days to Decision 13 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 127d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 577
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K800439.
COMPOSITE RESTORATIVE, PASTE/PASTE TYPE
K801798 · Scientific Pharmaceuticals, Inc. · Aug 1980
KERR CORE COMPOSITE
K801529 · Sybron Corp. · Aug 1980
PRISMA-FILL
K801092 · Dentsply Intl. · May 1980
COMPOSITE RESTORATIVE, PASTE/TYPE
K792140 · Scientific Pharmaceuticals, Inc. · Nov 1979
SCI-PHARM POLIFIL ANTERIOR RESTORATIVE
K791602 · Scientific Pharmaceuticals, Inc. · Nov 1979
VISIO-DISPERS
K790823 · Espe GmbH (Us) · Oct 1979