Cleared Traditional

K990482 - 3M CLINPRO PROPHY PASTE, MODEL 12611 (FDA 510(k) Clearance)

Class I Dental device.

K990482 · Minnesota Mining and Mfg. Co. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
86d
Days
Class 1
Risk

K990482 is an FDA 510(k) clearance for the 3M CLINPRO PROPHY PASTE, MODEL 12611. Classified as Agent, Polishing, Abrasive, Oral Cavity (product code EJR), Class I - General Controls.

Submitted by Minnesota Mining and Mfg. Co. (St. Paul, US). The FDA issued a Cleared decision on May 13, 1999 after a review of 86 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 Minnesota Mining and Mfg. Co. devices

Submission Details

510(k) Number K990482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1999
Decision Date May 13, 1999
Days to Decision 86 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 127d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.