Cleared Traditional

K172398 - DENTCA DENTURE Teeth

K172398 is an FDA 510(k) clearance for DENTCA DENTURE Teeth, manufactured by Dentca, Inc.. The device is a Class 2 Dental device with product code PZY cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K172398 · Dentca, Inc. · Dental device
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Nov 2017
Decision
106d
Days
Class 2
Risk

K172398 is an FDA 510(k) clearance for the DENTCA DENTURE Teeth. Classified as Additively Manufactured, Preformed, Resin Denture Tooth (product code PZY), Class II - Special Controls.

Submitted by Dentca, Inc. (Torrance, US). The FDA issued a Cleared decision on November 22, 2017 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3590 - 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 Dentca, Inc. devices

FDA 510(k) Submission Details - K172398

510(k) Number K172398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2017
Decision Date November 22, 2017
Days to Decision 106 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 127d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PZY Device Classification - Class 2, Special Controls

Product Code PZY Additively Manufactured, Preformed, Resin Denture Tooth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3590
Definition For The Fabrication Of Preformed Denture Teeth For Use In A Denture Base
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.