Cleared Traditional

K853447 - POLYCARB WATER SET

K853447 is the FDA 510(k) clearance for POLYCARB WATER SET by Pulpdent Corp. of America. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K853447 · Pulpdent Corp. of America · Dental device
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Oct 1985
Decision
61d
Days
Class 2
Risk

K853447 is an FDA 510(k) clearance for the POLYCARB WATER SET. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Pulpdent Corp. of America (Brookline, US). The FDA issued a Cleared decision on October 16, 1985 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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. of America devices

Submission Details

510(k) Number K853447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1985
Decision Date October 16, 1985
Days to Decision 61 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 127d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EMA Cement, Dental

All 285
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K853447.
KULZER GLASS IONOMER LINER
K863141 · Shofu Dental Corp. · Aug 1986
SHOFU LINING CEMENT
K862280 · Shofu Dental Corp. · Jun 1986
GLASIONOMER BASE CEMENT
K861005 · Shofu Dental Corp. · Apr 1986
GLAS IONOMER CEMENT
K850913 · Shofu Dental Corp. · Apr 1985
ESPE KETAC-CEM RADIOPAQUE
K844846 · Espe GmbH (Us) · Mar 1985
KETAC-SILVER
K843566 · Espe GmbH (Us) · Dec 1984