Dental Lithium Disilicate Glass-Ceramic (K230487)

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Dental Lithium Disilicate Glass-Ceramic

Model / Reference

HT-A1, HT-A2, HT-A3, MT-A1, MT-A2, MT-A3, MT-B1, MT-B2, MT-C1, MT-C2, MT-BL1, MT-BL2, MT-BL3, MT-BL4, LT-A1, LT-A2, LT-A3, LT-A3.5, LT-A4, LT-B1, LT-B2, LT-B3, LT-C1, LT-C2, LT-C3, LT-D2, LT-D3, LT-BL1, LT-BL2, LT-BL3, LT-BL4, MO0, MO1, 0401130

FDA applicant

Fuzhou Rick Brown Biomaterials Co., Ltd.

Primary DI / UDI-DI

06976146411410

Basic UDI-DI

697614641DLDGC01NX

510(k) Number

K230487 ↗

FDA Product Code

EIH

EMDN Code

Q010699 Materials for the preparation of custom-made dental devices - other

Device Class

Class IIa EUDAMED

Class II 510(k)

Regulation

21 CFR Part 872.6660

EU market of registration

Spain

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Dental Lithium Disilicate Glass-Ceramic

  Class IIa

  CE/MDR

• Dental Lithium Disilicate Glass-Ceramic

  Class IIa

  CE/MDR

• Dental Lithium Disilicate Glass-Ceramic

  Class IIa

  CE/MDR

• Dental Lithium Disilicate Glass-Ceramic

  Class IIa

  CE/MDR

• Dental Lithium Disilicate Glass-Ceramic

  Class IIa

  CE/MDR

• Dental Lithium Disilicate Glass-Ceramic

  Class IIa

  CE/MDR

See all devices from Fuzhou Rick Brown Biomaterials Co. Ltd. →

• What types of dental restorations can this lithium disilicate glass-ceramic material be used to create, and how is it processed?

  This material is specifically designed for manufacturing high-strength, translucent restorations such as crowns, inlays, onlays, veneers, and 3-unit anterior bridges. It is supplied as pre-fabricated blocks in cuboid or cylindrical shapes, intended for use in dental laboratories. The blocks are processed via milling or hot-pressing techniques enabled by CAD/CAM technology, allowing for precise fabrication of custom restorations.

• Is this material single-use, and how should it be handled to ensure sterility before processing?

  Yes, each block of this lithium disilicate glass-ceramic is intended for single-use only. Since it requires sterile handling prior to milling or processing, it must be stored and prepared in a manner that maintains its sterility, ensuring a clean and uncontaminated environment before use in dental restorations.

• What regulatory pathways does this dental lithium disilicate glass-ceramic follow, and what does that mean for its use?

  This material is regulated under both FDA 510(k) clearance (K230487) and MDR compliance, meaning it has undergone evaluation to demonstrate substantial equivalence to a predicate device and meets European dental material safety standards. This ensures its suitability for aesthetic and structurally sound dental restorations, adhering to established regulatory requirements for dental ceramics.

• Are there any special storage requirements for this material, and how should it be stored before use?

  While specific storage conditions aren’t detailed in the provided data, as a sterile, single-use dental material, it should be stored in a clean, dry environment protected from contamination, moisture, and extreme temperatures. Proper packaging should remain intact until immediately before use to preserve sterility and integrity.