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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 128d · 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.

Regulatory Consultant

Denterprise International, Inc.
Joyce St. Germain

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.