Cleared Traditional

K911284 - PULPDENT DIAMOND POLISH

K911284 is an FDA 510(k) clearance for PULPDENT DIAMOND POLISH, manufactured by Pulpdent Corp.. The device is a Class 1 Dental device with 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.

FDA 510(k) Submission Details - K911284

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
38d faster than avg
Panel avg: 128d · This submission: 90d
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 76
Devices cleared under the same product code (EJR) and FDA review panel - the closest regulatory comparables to K911284.
CLEANIC
K923020 · Hawe Neos Dental · Sep 1992
SATIN PROPHYLAXIS PASTE
K912945 · Dentsply Intl. · Sep 1991
ABUTMENT GLO
K905303 · Implant Innovations International, Inc. · Jun 1991
SWIRL PROPHYLAXIS PASTE
K903986 · Bio-Medica Concepts · Mar 1991
HORIZON REGULAR ETCHING GEL
K904199 · Horizon Chemical Co. · Dec 1990
PROPHY PASTE
K901580 · Dentsply Intl. · Sep 1990
K911284 · PULPDENT DIAMOND POLISH
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