Cleared Traditional

Zirconia Block (K241316) - FDA 510(k) Clearance

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

K241316 · Hunan Hualian Special Ceramics Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
60d
Days
Class 2
Risk

K241316 is an FDA 510(k) clearance for the Zirconia Block. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Hunan Hualian Special Ceramics Co., Ltd. (Liling, CN). The FDA issued a Cleared decision on July 9, 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 Hualian Special Ceramics Co., Ltd. devices

Submission Details

510(k) Number K241316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2024
Decision Date July 09, 2024
Days to Decision 60 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
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 K241316.
Kingcera Dental Zirconia Blank
K241602 · Hunan Qinghao Puzhong Technology Co., Ltd. · Aug 2024
Cercon® yo ML
K241557 · Dentsply Sirona · Aug 2024
Dental Glass Ceramics Blocks (HT,LT,ST)
K241715 · Aidite (Qinhuangdao) Technology Co., Ltd. · Jul 2024
Copran Zri
K232952 · Whitepeaks Dental Solutions GmbH · Jun 2024
rainbow Paste Stain SE
K233885 · Genoss Co., Ltd. · Jun 2024
Copra Smile, Copra Supreme Hyperion
K233158 · Whitepeaks Dental Solutions GmbH · Jun 2024