Cleared Traditional

K864215 - PROPHY CARE SOLUTION

K864215 is an FDA 510(k) clearance for PROPHY CARE SOLUTION, manufactured by Imd, Inc.. The device is a Class 1 Dental device with product code EJR cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K864215 · Imd, Inc. · Dental device
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Nov 1986
Decision
21d
Days
Class 1
Risk

K864215 is an FDA 510(k) clearance for the PROPHY CARE SOLUTION. Classified as Agent, Polishing, Abrasive, Oral Cavity (product code EJR), Class I - General Controls.

Submitted by Imd, Inc. (Franklin Lakes, US). The FDA issued a Cleared decision on November 18, 1986 after a review of 21 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 Imd, Inc. devices

FDA 510(k) Submission Details - K864215

510(k) Number K864215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1986
Decision Date November 18, 1986
Days to Decision 21 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: 127d · This submission: 21d
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 K864215.
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
RENAMELIZE POLISHING PASTE
K862912 · Cosmedent, Inc. · Aug 1986
SCI-PRO, PROPHYLAXIS PASTE
K854828 · Scientific Pharmaceuticals, Inc. · Mar 1986
DENSCO PROPHY PASTE
K854829 · Scientific Pharmaceuticals, Inc. · Mar 1986