Cleared Traditional

K884391 - PREMET

K884391 is the FDA 510(k) clearance for PREMET by Scientific Pharmaceuticals, Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K884391 · Scientific Pharmaceuticals, Inc. · Dental device
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Jan 1989
Decision
77d
Days
Class 2
Risk

K884391 is an FDA 510(k) clearance for the PREMET, METAL PRIMER. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Scientific Pharmaceuticals, Inc. (Duarte, US). The FDA issued a Cleared decision on January 3, 1989 after a review of 77 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 K884391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1988
Decision Date January 03, 1989
Days to Decision 77 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
50d faster than avg
Panel avg: 127d · This submission: 77d
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 K884391.
ADHERENCE M5 MULTI-CURE COMPOSITE CEMENT SYSTEM
K891463 · Confi-Dental Products Co. · May 1989
PHOSPHORIC-ACID ETCHING GEL
K890140 · Centrix, Inc. · Mar 1989
UNIREST COMPOSITE RESTORATIVE, SELF CURED
K884350 · Scientific Pharmaceuticals, Inc. · Jan 1989
UNIREST LC PAINT-ON RESTORATIVE & VENEER CEMENT
K884681 · Scientific Pharmaceuticals, Inc. · Jan 1989
UNIREST PL, ANTE./POST. RESTORATIVE, PASTE/LIQUID
K884351 · Scientific Pharmaceuticals, Inc. · Dec 1988
SMILE-DENT ANTE./POST. RESTORATIVE, LIGHT-CURED
K884352 · Scientific Pharmaceuticals, Inc. · Dec 1988