Cleared Traditional

K854106 - BAYSILEX

K854106 is an FDA 510(k) clearance for BAYSILEX, manufactured by Cutter Laboratories, Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K854106 · Cutter Laboratories, Inc. · Dental device
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Mar 1986
Decision
160d
Days
Class 2
Risk

K854106 is an FDA 510(k) clearance for the BAYSILEX. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Cutter Laboratories, Inc. (Berkeley, US). The FDA issued a Cleared decision on March 17, 1986 after a review of 160 days - an extended review cycle.

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. 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.

View all Cutter Laboratories, Inc. devices

FDA 510(k) Submission Details - K854106

510(k) Number K854106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1985
Decision Date March 17, 1986
Days to Decision 160 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
33d slower than avg
Panel avg: 127d · This submission: 160d
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 171
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K854106.
NEW LIGHT-CURING IMPRESSION MATERIAL
K862879 · Dentsply Intl. · Sep 1986
KERR POL-E-LASTIC DENTAL IMPRESSION MATERIAL
K860532 · Kerr Corporation (Danbury) · Mar 1986
IMPREGUM-F
K853529 · Espe GmbH (Us) · Mar 1986
POLYJEL N.F. (NEW FORMULA)
K860146 · Dentsply Intl. · Mar 1986
PROOF ALGINATE IMPRESSION MATERIAL
K854855 · Sybron Corp. · Jan 1986
PERFOURM
K842324 · Cutter Laboratories, Inc. · Nov 1984