Cleared Traditional

DentCare Aligners (K222918) - FDA 510(k) Clearance

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

K222918 · Dentcare Dental Lab Pvt , Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2022
Decision
60d
Days
Class 2
Risk

K222918 is an FDA 510(k) clearance for the DentCare Aligners. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Dentcare Dental Lab Pvt , Ltd. (Ernakulam, IN). The FDA issued a Cleared decision on November 25, 2022 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5470 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dentcare Dental Lab Pvt , Ltd. devices

Submission Details

510(k) Number K222918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2022
Decision Date November 25, 2022
Days to Decision 60 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
67d faster than avg
Panel avg: 127d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NXC Aligner, Sequential
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5470
Definition The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion.
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

Liberty Management Group , Ltd.
Manoj Zacharias

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 - NXC Aligner, Sequential

All 123
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K222918.
Toothsi, Smilealigners
K223338 · Makeo Healthcare Technologies Private Limited · Feb 2023
Invisalign System, Pre-Formed Attachment System
K222894 · Align Technology, Inc. · Dec 2022
Al Smile Aligner
K222308 · Nanjing Jiahe Dental Technology Co., Ltd. · Dec 2022
Tera Harz Clear
K223355 · Graphy, Inc. · Nov 2022
CREOKORREKT Aligners
K211427 · Creodent Prosthetics, Ltd. · Oct 2022
Nuvola
K222418 · Gruppo Europeo Ortodonzia Srl · Oct 2022