Cleared Traditional

Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO) (K242740) - FDA 510(k) Clearance

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

K242740 · Liaoning Rachcera Material Technology Co., Ltd. · Dental device
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Dec 2024
Decision
85d
Days
Class 2
Risk

K242740 is an FDA 510(k) clearance for the Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO). Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Liaoning Rachcera Material Technology Co., Ltd. (Shenyang, CN). The FDA issued a Cleared decision on December 5, 2024 after a review of 85 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 Liaoning Rachcera Material Technology Co., Ltd. devices

Submission Details

510(k) Number K242740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2024
Decision Date December 05, 2024
Days to Decision 85 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
42d faster than avg
Panel avg: 127d · This submission: 85d
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 K242740.
Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid )
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