Cleared Traditional

K170423 - DentureID Microchip (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K170423 · Cmp Industries, LLC · General Hospital
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Oct 2017
Decision
254d
Days
Class 2
Risk

K170423 is an FDA 510(k) clearance for the DentureID Microchip. Classified as Rfid Chip For Dental Appliance (product code PYQ), Class II - Special Controls.

Submitted by Cmp Industries, LLC (Albany, US). The FDA issued a Cleared decision on October 25, 2017 after a review of 254 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6300 - the FDA general hospital device 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K170423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2017
Decision Date October 25, 2017
Days to Decision 254 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 128d · This submission: 254d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PYQ Rfid Chip For Dental Appliance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6300
Definition The Device Is Intended To Enable Access To Secure Patient Identification And Device Information When Used With Complete Dentures, Partial Dentures, And Other Removable Oral Appliances.
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 General Hospital devices follow this clearance model.