510(k) K242740

Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO) by Liaoning Rachcera Material Technology Co., Ltd. — Product Code EIH

K242740 is an FDA 510(k) premarket notification submitted by Liaoning Rachcera Material Technology Co., Ltd. for the device "Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO)". The FDA issued a decision of Substantially Equivalent on December 5, 2024. The device falls under product code EIH (Powder, Porcelain), a Class II device regulated under 21 CFR 872.6660.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2024
Date Received
September 11, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Powder, Porcelain
Device Class
Class II
Regulation Number
872.6660
Review Panel
DE
Submission Type