Cleared Traditional

Dental Impression Material (K221668) - FDA 510(k) Clearance

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

K221668 · Chemoment Materials Co.,Ltd · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2022
Decision
61d
Days
Class 2
Risk

K221668 is an FDA 510(k) clearance for the Dental Impression Material. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Chemoment Materials Co.,Ltd (Hefei, CN). The FDA issued a Cleared decision on August 8, 2022 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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 Chemoment Materials Co.,Ltd devices

Submission Details

510(k) Number K221668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2022
Decision Date August 08, 2022
Days to Decision 61 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
66d faster than avg
Panel avg: 127d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
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

Shanghai Sungo Management Consulting Company Limited.
Ivy Wang

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 - ELW Material, Impression

All 84
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K221668.
Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty
K214086 · Genoss Co., Ltd. · Dec 2022
DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)
K222741 · Hdi, Inc. · Nov 2022
Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration)
K213244 · Prevest Denpro Limited · Sep 2022
IMICRYL Impression Materials
K213890 · Imicryl Dis Malzemeleri San. VE Tic. A.S. · Feb 2022
Permadyne
K220257 · 3M Deutschland GmbH · Feb 2022
PRESIDENT The Original
K220097 · Colt?ne/Whaledent AG · Jan 2022