Cleared Traditional

K242407 - Dental Glass Ceramics Blocks (HT

K242407 is an FDA 510(k) clearance for Dental Glass Ceramics Blocks (HT, manufactured by Hunan Vsmile Biotechnology Co., Ltd.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K242407 · Hunan Vsmile Biotechnology Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2024
Decision
91d
Days
Class 2
Risk

K242407 is an FDA 510(k) clearance for the Dental Glass Ceramics Blocks (HT, LT, MT). Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Hunan Vsmile Biotechnology Co., Ltd. (Hi-Tech Development District Changsha, CN). The FDA issued a Cleared decision on November 13, 2024 after a review of 91 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. 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 Hunan Vsmile Biotechnology Co., Ltd. devices

FDA 510(k) Submission Details - K242407

510(k) Number K242407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2024
Decision Date November 13, 2024
Days to Decision 91 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
36d faster than avg
Panel avg: 127d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EIH Device Classification - Class 2, Special Controls

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 285
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K242407.
VITA YZ Multi Translucent
K243940 · Vita Zahnfabrik H.Rauter GmbH & Co. · Feb 2025
Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO)
K242740 · Liaoning Rachcera Material Technology Co., Ltd. · Dec 2024
Estar-ZE
K242521 · Osstem Implant Co., Ltd. · Nov 2024
ArgenZ MTZ
K242458 · Argen Corporation · Oct 2024
CEREC Cercon 4D CAD/CAM Blocks
K242462 · Dentsply Sirona · Oct 2024
Dental porcelain powder
K242400 · Yilink (Tianjin) Biotechnology Co., Ltd. · Oct 2024