Cleared Traditional

K172764 - Keymill

K172764 is the FDA 510(k) clearance for Keymill by Mycone Dental Supply Company, Inc. (Aka Keystone Industries). It is a Class 2 Dental device (product code EBI) cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K172764 · Mycone Dental Supply Company, Inc. (Aka Keystone Industries) · Dental device
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Apr 2018
Decision
226d
Days
Class 2
Risk

K172764 is an FDA 510(k) clearance for the Keymill. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Mycone Dental Supply Company, Inc. (Aka Keystone Industries) (Gibbstown, US). The FDA issued a Cleared decision on April 27, 2018 after a review of 226 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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 Mycone Dental Supply Company, Inc. (Aka Keystone Industries) devices

Submission Details

510(k) Number K172764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2017
Decision Date April 27, 2018
Days to Decision 226 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 127d · This submission: 226d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 121
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