Cleared Traditional

K844446 - BISICO SL(PUTTY) BISICO S2(REGULAR) S3 HEAVY ETC.

K844446 is an FDA 510(k) clearance for BISICO SL(PUTTY) BISICO S2(REGULAR) S3 ..., manufactured by Pulpdent Corp. of America. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 347-day FDA review.

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

FDA 510(k) Submission Details - K844446

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.

ELW Device Classification - Class 2, Special Controls

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 323
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K844446.
BAYSILEX
K854106 · Cutter Laboratories, Inc. · Mar 1986
POLYJEL N.F. (NEW FORMULA)
K860146 · Dentsply Intl. · Mar 1986
PROOF ALGINATE IMPRESSION MATERIAL
K854855 · Sybron Corp. · Jan 1986
SEPTOSIL SILICONE FOR PRECISION IMPRESSION
K851388 · Specialites Septodont · May 1985
76 ELW BITE CHECKER SILICONE
K851469 · G-C Intl. Corp. · May 1985
ABSOLUTE VINYL POLYSILOXANE IMPRESS
K842877 · Coe Laboratories, Inc. · Mar 1985