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FDA 510(k)

Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO)

K-Number: K242740 · 2024-12-05

ApplicantLiaoning Rachcera Material Technology Co., Ltd.
Decision Date2024-12-05
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO) is a medical device manufactured by Liaoning Rachcera Material Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-12-05 under approval number K242740. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO)?

Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO) is a medical device that received FDA 510(k) clearance on 2024-12-05. It is manufactured by Liaoning Rachcera Material Technology Co., Ltd.. The 510(k) number is K242740.

When was Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO) approved by the FDA?

Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO) received FDA 510(k) clearance on 2024-12-05, under approval number K242740.

What company makes Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO)?

Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO) is manufactured by Liaoning Rachcera Material Technology Co., Ltd..

What is the FDA product code for Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO)?

The FDA product code for Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO) is EIH.

Related Clinical Trials

NCT07261137 Efficacy of Solventum™ Vitrebond™ Pulp Protect Liner/Base Used as a Liner/Base Under Dental Restorations TERMINATED NCT04695899 Zirconia Implants for Replacement of a Single Tooth ACTIVE_NOT_RECRUITING NCT07521501 Clinical Behavior and Patient Satisfaction of Zirconia-reinforced Glass-ceramic Crowns and Ultra-translucent-multilayered Monolithic Zirconia Crowns With a Conservative Marginal Design NOT_YET_RECRUITING NCT07500636 Long-Term Periodontal Tissue Changes Associated With Metal-Ceramic Crowns: An 8-Year Split-Mouth Study COMPLETED NCT07504393 Clinical Performance of Four Restorative Materials in Primary Molars NOT_YET_RECRUITING

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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