Cleared Traditional

K842877 - ABSOLUTE VINYL POLYSILOXANE IMPRESS

K842877 is an FDA 510(k) clearance for ABSOLUTE VINYL POLYSILOXANE IMPRESS, manufactured by Coe Laboratories, Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K842877 · Coe Laboratories, Inc. · Dental device
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Mar 1985
Decision
231d
Days
Class 2
Risk

K842877 is an FDA 510(k) clearance for the ABSOLUTE VINYL POLYSILOXANE IMPRESS. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Coe Laboratories, Inc. (Alsip, US). The FDA issued a Cleared decision on March 11, 1985 after a review of 231 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 Coe Laboratories, Inc. devices

FDA 510(k) Submission Details - K842877

510(k) Number K842877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1984
Decision Date March 11, 1985
Days to Decision 231 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
104d slower than avg
Panel avg: 127d · This submission: 231d
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 322
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K842877.
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
SURFLEX F
K844329 · G-C Intl. Corp. · Dec 1984
PERFOURM
K842324 · Cutter Laboratories, Inc. · Nov 1984
TWO COMPONENT RTV VINYL SILICONE MATER
K843145 · Crown Delta Corp. · Oct 1984