Cleared Traditional

BISICO SL(PUTTY) BISICO S2(REGULAR) S3 HEAVY ETC. (K844446) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K844446 · Pulpdent Corp. of America · Dental device
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Oct 1985
Decision
347d
Days
Class 2
Risk

K844446 is an FDA 510(k) clearance for the BISICO SL(PUTTY) BISICO S2(REGULAR) S3 HEAVY ETC.. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Pulpdent Corp. of America (Brookline, US). The FDA issued a Cleared decision on October 29, 1985 after a review of 347 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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. Elevated predicate reliance profile. 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. of America devices

Submission Details

510(k) Number K844446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1984
Decision Date October 29, 1985
Days to Decision 347 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
220d slower than avg
Panel avg: 127d · This submission: 347d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
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 - ELW Material, Impression

All 52
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K844446.
HYDROPHILIC REPROSIL
K863288 · Dentsply Intl. · Dec 1986
NEW LIGHT-CURING IMPRESSION MATERIAL
K862879 · Dentsply Intl. · Sep 1986
POLYJEL N.F. (NEW FORMULA)
K860146 · Dentsply Intl. · Mar 1986
ALGINATE IMPRESSION MATERIAL
K802362 · Dentsply Intl. · Oct 1980
ASH BLUEPRINT ALGINATE IMPRESSION MATER.
K801587 · Dentsply Intl. · Jul 1980
VINYL POLYSILOXANE IMPRESSION MATERIAL
K800485 · 3M Company · Mar 1980