Cleared Traditional

K162044 - Dentca Denture Base II

K162044 is an FDA 510(k) clearance for Dentca Denture Base II, manufactured by Dentca, Inc.. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K162044 · Dentca, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2017
Decision
221d
Days
Class 2
Risk

K162044 is an FDA 510(k) clearance for the Dentca Denture Base II. Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Dentca, Inc. (Torrance, US). The FDA issued a Cleared decision on March 3, 2017 after a review of 221 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 Dentca, Inc. devices

FDA 510(k) Submission Details - K162044

510(k) Number K162044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2016
Decision Date March 03, 2017
Days to Decision 221 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
93d slower than avg
Panel avg: 128d · This submission: 221d
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 Consultant

Denterprise International, Inc.
Claude Berthoin

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.

Regulatory Peers - EBI Resin, Denture, Relining, Repairing, Rebasing

All 277
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K162044.
NextDent Denture, E-Denture
K162572 · Vertex-Dental B.V. · Jun 2017
Orthodontic Acrylic 2
K163482 · Lang Dental Manufacturing Co., Inc. · May 2017
mollosil plus
K162654 · Detax GmbH & Co. KG · Mar 2017
JUVORA Dental Disc, Ceramill PEEK by JUVORA
K160918 · Juvora · Feb 2017
Pour Acrylic
K161330 · Dentsply Sirona · Oct 2016
PINK CAD/CAM disc
K153546 · Polident D.O.O., Dental Products Industry · Sep 2016