Cleared Traditional

K911284 - PULPDENT DIAMOND POLISH

K911284 is the FDA 510(k) clearance for PULPDENT DIAMOND POLISH by Pulpdent Corp.. It is a Class 1 Dental device (product code EJR) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K911284 · Pulpdent Corp. · Dental device
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May 1991
Decision
90d
Days
Class 1
Risk

K911284 is an FDA 510(k) clearance for the PULPDENT DIAMOND POLISH. Classified as Agent, Polishing, Abrasive, Oral Cavity (product code EJR), Class I - General Controls.

Submitted by Pulpdent Corp. (Watertown, US). The FDA issued a Cleared decision on May 30, 1991 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Pulpdent Corp. devices

Submission Details

510(k) Number K911284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1991
Decision Date May 30, 1991
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
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.

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

All 26
Devices cleared under the same product code (EJR) and FDA review panel - the closest regulatory comparables to K911284.
NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN
K000169 · Dentsply Intl. · Mar 2000
NUPRO PROPHYLAXIS PASTE WITH FLOURIDE AND TRICLOSAN
K983966 · Dentsply Intl. · Jan 1999
SATIN PROPHYLAXIS PASTE
K912945 · Dentsply Intl. · Sep 1991
PROPHY PASTE
K901580 · Dentsply Intl. · Sep 1990
ULTRA II PORCELAIN POLISHING PASTE
K896071 · Shofu Dental Corp. · Aug 1990
DEGUFILL (R) POLISHING GEL
K901873 · Degussa AG · Aug 1990