Cleared Traditional

K813090 - COMPOSITE DENTAL RESTORATIVE MATERIAL

K813090 is an FDA 510(k) clearance for COMPOSITE DENTAL RESTORATIVE MATERIAL, manufactured by Sci-Pharm, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K813090 · Sci-Pharm, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1981
Decision
22d
Days
Class 2
Risk

K813090 is an FDA 510(k) clearance for the COMPOSITE DENTAL RESTORATIVE MATERIAL. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Sci-Pharm, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 24, 1981 after a review of 22 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 Sci-Pharm, Inc. devices

FDA 510(k) Submission Details - K813090

510(k) Number K813090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1981
Decision Date November 24, 1981
Days to Decision 22 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 128d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

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 821
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K813090.
ESTILUX POSTERIOR XR
K813568 · Kulzer, Inc. · Jan 1982
ZEON COMPOSITE RESIN SYSTEM
K820006 · National Patent Development Corp. · Jan 1982
CAULK OPAQUER
K813357 · Dentsply Intl. · Jan 1982
ESTILUX POSTERIOR
K812889 · Kulzer, Inc. · Nov 1981
ADAPTIC* C.F.S.
K812449 · Johnson & Johnson Professionals, Inc. · Sep 1981
VISIO-FIL
K812169 · Espe GmbH (Us) · Sep 1981