Cleared Traditional

K850036 - COLTENE PRECISE

K850036 is an FDA 510(k) clearance for COLTENE PRECISE, manufactured by Coltene, Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K850036 · Coltene, Inc. · Dental device
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Feb 1985
Decision
32d
Days
Class 2
Risk

K850036 is an FDA 510(k) clearance for the COLTENE PRECISE. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Coltene, Inc. (Chicago, US). The FDA issued a Cleared decision on February 8, 1985 after a review of 32 days - a notably fast clearance 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: 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 Coltene, Inc. devices

FDA 510(k) Submission Details - K850036

510(k) Number K850036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1985
Decision Date February 08, 1985
Days to Decision 32 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 127d · This submission: 32d
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 330
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K850036.
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
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