Cleared Traditional

K891536 - ENAMEL MICROABRASION COMPOUND

K891536 is an FDA 510(k) clearance for ENAMEL MICROABRASION COMPOUND, manufactured by Premier Dental Products Co.. The device is a Class 1 Dental device with product code EJR cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K891536 · Premier Dental Products Co. · Dental device
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Jun 1989
Decision
84d
Days
Class 1
Risk

K891536 is an FDA 510(k) clearance for the ENAMEL MICROABRASION COMPOUND. Classified as Agent, Polishing, Abrasive, Oral Cavity (product code EJR), Class I - General Controls.

Submitted by Premier Dental Products Co. (Norristown, US). The FDA issued a Cleared decision on June 9, 1989 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6030 - 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 Premier Dental Products Co. devices

FDA 510(k) Submission Details - K891536

510(k) Number K891536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1989
Decision Date June 09, 1989
Days to Decision 84 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
43d faster than avg
Panel avg: 127d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

EJR Device Classification - Class 1, General Controls

Product Code EJR Agent, Polishing, Abrasive, Oral Cavity
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6030
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EJR Agent, Polishing, Abrasive, Oral Cavity

All 31
Devices cleared under the same product code (EJR) and FDA review panel - the closest regulatory comparables to K891536.
DEGUFILL (R) POLISHING GEL
K901873 · Degussa AG · Aug 1990
PULPDENT OIL FREE SURFACE PREPARATION PASTE
K901052 · Pulpdent Corp. · Apr 1990
KEN'S PROPHY GEL - REGULAR
K896661 · Pulpdent Corp. · Feb 1990
DIAMOND-LUSTER DENTAL POLISHING PASTE
K873686 · Scientific Pharmaceuticals, Inc. · Nov 1987
ABRASIVE DISC - POLISHING WHEEL
K872251 · Dentsply Intl. · Jul 1987
JOHNSON & JOHNSON STAINING REMOVING COMPOUND
K864226 · Johnson & Johnson Professionals, Inc. · May 1987