Cleared Traditional

K172764 - Keymill

K172764 is an FDA 510(k) clearance for Keymill, manufactured by Mycone Dental Supply Company, Inc. (Aka Keystone Industries). The device is a Class 2 Dental device with 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.

FDA 510(k) Submission Details - K172764

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
98d slower than avg
Panel avg: 128d · This submission: 226d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBI Device Classification - Class 2, Special Controls

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 305
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K172764.
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K172407 · The Myerson Company Limited · Nov 2017
Nobilplast Denture Resin
K170375 · Cmp Industries, LLC · Oct 2017
K172764 · Keymill
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