Cleared Traditional

K810907 - COLTENE ORALLY

K810907 is the FDA 510(k) clearance for COLTENE ORALLY by Coltene, Inc.. It is a Class 2 Dental device (product code EJJ) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K810907 · Coltene, Inc. · Dental device
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Apr 1981
Decision
20d
Days
Class 2
Risk

K810907 is an FDA 510(k) clearance for the COLTENE ORALLY. Classified as Alloy, Amalgam (product code EJJ), Class II - Special Controls.

Submitted by Coltene, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 23, 1981 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3070 - 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

Submission Details

510(k) Number K810907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1981
Decision Date April 23, 1981
Days to Decision 20 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 127d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EJJ Alloy, Amalgam
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3070
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 - EJJ Alloy, Amalgam

All 24
Devices cleared under the same product code (EJJ) and FDA review panel - the closest regulatory comparables to K810907.
A DENTAL AMALGAM ALLOY (UNNAMED
K820389 · Dentsply Intl. · Mar 1982
SYBRON/KERR CONTOUR
K820181 · Sybron Corp. · Feb 1982
ORBIC* SPHERICAL ALLOY
K812827 · Johnson & Johnson Professionals, Inc. · Nov 1981
ALLOY, AMALGAM, DISP. CAPSULE
K781242 · Lee Pharmaceuticals · Aug 1978
LEE-ALLOY
K780967 · Lee Pharmaceuticals · Jun 1978
ALLOY DISPOS-A-CAP DENTAL SCHOOL CAP
K771383 · Johnson & Johnson Professionals, Inc. · Aug 1977