Cleared Traditional

K220042 - Dentca Base Premium

K220042 is an FDA 510(k) clearance for Dentca Base Premium, 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 316-day FDA review.

K220042 · Dentca, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2022
Decision
316d
Days
Class 2
Risk

K220042 is an FDA 510(k) clearance for the Dentca Base Premium, Dentca Base Hi-Impact. 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 November 17, 2022 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K220042

510(k) Number K220042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2022
Decision Date November 17, 2022
Days to Decision 316 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
189d slower than avg
Panel avg: 127d · This submission: 316d
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 156
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K220042.
Trusana™
K230098 · Myerson, LLC · Apr 2023
ACRIFIX
K230341 · Deltamed GmbH · Apr 2023
Denture Base Resin
K230115 · Aidite (Qinhuangdao) Technology Co., Ltd. · Mar 2023
SprintRay High Impact Denture Base
K221678 · Sprintray, Inc. · Nov 2022
V-Print dentbase
K220236 · Voco GmbH · Sep 2022
SprintRay Denture Base
K220979 · Sprintray, Inc. · Sep 2022