Cleared Traditional

K242407 - Dental Glass Ceramics Blocks (HT, LT, MT) (FDA 510(k) Clearance)

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

K242407 · Hunan Vsmile Biotechnology Co., Ltd. · Dental device
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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

Submission Details

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.

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 478
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K242407.
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