Dental Glass Ceramics Blocks

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.

Trade Name

Dental Glass Ceramics

Model / Reference

40×15×15-HT, 18×13×15-HT, 12.5×10-LT

Primary DI / UDI-DI

06979046190362, 06975209754389, 06975367004005, 06975164779595, 06975209755584, 06976087538993, 06975164779601, 06975367005484, 06975784826167, 06975209750589, 06975367004104, 06934906630372, 06970469232844, 06975164779557, 06975209754334, 06975367004739, 06975209754358, 06976087538948, 06970469232837, 06975784826143, 06975164779625, 06975209755546, 06970469232738

Basic UDI-DI

B-06979046190362, B-06975209754389, B-06975367004005, B-06975164779595, B-06975209755584, B-06976087538993, B-06975164779601, B-06975367005484, B-06975784826167, B-06975209750589, B-06975367004104, B-06934906630372, B-06970469232844, B-06975164779557, B-06975209754334, B-06975367004739, B-06975209754358, B-06976087538948, B-06970469232837, B-06975784826143, B-06975164779625, B-06975209755546, B-06970469232738

510(k) Number

K192231 ↗

FDA Product Code

EIH

EMDN Code

Q01010199 Dental restoration devices - other

Device Class

Class IIa EUDAMED

Class II 510(k)

Regulation

21 CFR Part 872.6660

EU market of registration

Germany

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Dental Crystallized Ceramics

  Class IIa

  CE/MDR

• Dental Glass Ceramics

  Class IIa

  CE/MDD

• Coloring Liquid Specialized for Aidite Zirconia Material

  Class IIa

  CE/MDD

• Dental Zirconia Ceramic

  Class IIa

  CE/MDD

• PMMA blocks for dental use

  Class IIa

  CE/MDD

• Denture Base Resin

  Class IIa

  CE/MDR CN26/00001383 Active Valid to Mar 2031

See all devices from Aidite (Qinhuangdao) Technology Co., Ltd. →

• What types of dental restorations can these glass ceramics blocks be used to create, and how are they processed?

  These Dental Glass Ceramics Blocks are specifically designed for fabricating high-strength, aesthetic dental prosthetics such as crowns, bridges, and inlays/onlays. They are processed using computer-aided design and computer-aided manufacturing (CAD/CAM) systems, where the blocks are milled or ground to achieve the precise shape required for the restoration.

• Are these blocks intended for reuse in a clinical setting, and if not, what does that mean for dental labs?

  No, these Dental Glass Ceramics Blocks are explicitly intended for single-use in dental laboratories or clinics equipped with CAD/CAM milling machines. This means each block is meant to be milled into a single restoration, ensuring material integrity and precision without risk of cross-contamination or degradation from repeated use.

• What hardness variants are available, and how might a clinician or lab choose between them?

  The blocks come in three hardness variants: HT (High-Toughness), LT (Low-Toughness), and ST (Standard-Toughness). The choice depends on the clinical need—HT for high-stress areas like molars, ST for general use, and LT for less demanding applications. Hardness affects wear resistance and milling efficiency, so the variant aligns with the restoration’s functional demands.

• How are these blocks supplied, and what should a dental lab consider when storing them?

  The blocks are supplied as porcelain powder-based ceramics in a format compatible with CAD/CAM systems, though specific packaging details (e.g., sterility, moisture barriers) aren’t provided. Labs should store them in a controlled environment—protected from humidity, temperature fluctuations, and physical damage—to preserve material integrity and ensure accurate milling results.

• What regulatory pathways have these blocks undergone, and how does that affect their use in the U.S.?

  The blocks received FDA 510(k) clearance under 21 CFR 872.6660, classified as substantially equivalent to a predicate device, and comply with the Medical Device Directive (MDD). This means they’re legally marketable in the U.S. for their intended CAD/CAM dental applications, though clinicians should confirm compliance with local state dental board requirements for material use.