Cleared Traditional

K896661 - KEN'S PROPHY GEL - REGULAR

K896661 is the FDA 510(k) clearance for KEN'S PROPHY GEL - REGULAR by Pulpdent Corp.. It is a Class 1 Dental device (product code EJR) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K896661 · Pulpdent Corp. · Dental device

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Feb 1990

Decision

82d

Days

Class 1

Risk

K896661 is an FDA 510(k) clearance for the KEN'S PROPHY GEL - REGULAR. 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 February 14, 1990 after a review of 82 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 Pulpdent Corp. devices

Submission Details

510(k) Number	K896661 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 24, 1989
Decision Date	February 14, 1990
Days to Decision	82 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

45d faster than avg

Panel avg: 127d · This submission: 82d

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 K896661.

ULTRA II PORCELAIN POLISHING PASTE

K896071 · Shofu Dental Corp. · Aug 1990

DEGUFILL (R) POLISHING GEL

K901873 · Degussa AG · Aug 1990

PULPDENT OIL FREE SURFACE PREPARATION PASTE

K901052 · Pulpdent Corp. · Apr 1990

ENAMEL MICROABRASION COMPOUND

K891536 · Premier Dental Products Co. · Jun 1989

DIAMOND-LUSTER DENTAL POLISHING PASTE

K873686 · Scientific Pharmaceuticals, Inc. · Nov 1987

ABRASIVE DISC - POLISHING WHEEL

K872251 · Dentsply Intl. · Jul 1987

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K896661

Pulpdent Corp.

Watertown, MA · US

KENNETH J BERK

Regulatory profile

78 submissions 78 cleared

100% clearance rate · Active in Dental

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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