Cleared Traditional

Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, UT-C, UT-ML, Pro- ML) (K240772) - FDA 510(k) Clearance

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

K240772 · Hunan Ceramaster Material Technology Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
60d
Days
Class 2
Risk

K240772 is an FDA 510(k) clearance for the Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, UT-C, UT-ML, Pro.... Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Hunan Ceramaster Material Technology Co., Ltd. (Changsha, CN). The FDA issued a Cleared decision on May 20, 2024 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - 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 Hunan Ceramaster Material Technology Co., Ltd. devices

Submission Details

510(k) Number K240772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2024
Decision Date May 20, 2024
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 EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
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 - EIH Powder, Porcelain

All 184
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K240772.
Copra Smile, Copra Supreme Hyperion
K233158 · Whitepeaks Dental Solutions GmbH · Jun 2024
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ( ZD-HT-PLUS, ZD-ST, ZD-SHT, ZD-HT-C, ZD-ST-C, ZD-SHT-C, ZD-UT-C, ZD-ST-ML, ZD-SHT-ML, ZD-UT-ML, ZD-3D-Pro-ML, ZD-4D-Pro-ML)
K240672 · Zhejiang Zahndent Biotechnology Co., Ltd. · Jun 2024
Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro)
K240912 · Anhui Miisen Intelligence Technology Co., Ltd. · May 2024
BruxZir® Esthetic
K240882 · Prismatik Dentalcraft, Inc. · May 2024
UltraThineer Zirconia Slurry (5Y-B)
K240419 · Boston Micro Fabrication · Apr 2024
BruxZir® Radiant
K240574 · Prismatik Dentalcraft, Inc. · Mar 2024