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

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.

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