Zolid Lunaris

Zolid Lunaris is a zirconia ceramic blank for CAD/CAM manufacture of fixed dental restorations. The material is shaped into single-tooth or multi-unit prostheses that replace missing or…

Registry build 21.09.26

Zolid Lunaris is a zirconia ceramic blank for CAD/CAM manufacture of fixed dental restorations. The material is shaped into single-tooth or multi-unit prostheses that replace missing or damaged teeth.

Its zirconia structure combines a 3Y-TZP basal zone for mechanical stability with a 4Y-TZP incisal zone for optical properties. This gives different material roles to the base and the visible incisal part of the restoration.

Disc Formats

The nonsterile blanks have a 98 mm diameter and seven height options from 12 to 30 mm. They are classified as Type II, Class 5 dental ceramic under ISO 6872. The restoration made from the blank is intended for single use.

33manufacturers in China registered for this device type
147catalogue numbers in this listing
2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (10), Hunan (6), Hebei (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EIH
Manufacturer City Province Registered as Device types
BMF Tech (Zhuhai) Inc. Zhuhai Guangdong Contract manufacturer 2
Jiangxi Rekonova Dental Materials Co., Ltd. Jiujiang Jiangxi Contract manufacturer 1
Aidite (Qinhuangdao) Technology Co., Ltd. Qinhuangdao Hebei Repacker / relabeller 17
Shandong Huge Dental Material Corporation Rizhao Shandong Manufacturer 17
Chengdu Besmile Medical Technology Co., Ltd. Chengdu Sichuan Manufacturer 14
Qinhuangdao Audental Metal Technology Co., Ltd. Qinhuangdao Hebei Manufacturer 11
Liaoning Upcera Co., Ltd. Benxi Liaoning Contract manufacturer 10
Shenzhen Upcera Digital Dental Technology Co., Ltd. Shenzhen Guangdong Exporter 10
Rizhao Huge Biomaterials Company, Ltd. Rizhao Shandong Manufacturer 7
Shenzhen Yurucheng Dental Materials Co., Ltd. Shenzhen Guangdong Manufacturer 6
Hunan Vsmile Biotechnology Co., Ltd. Changsha Hunan Contract manufacturer 6
Deprag High Tech Materials ( Zhengzhou ) Co., Ltd. Zhangzhou Henan Manufacturer 6

Showing 12 of 33. All 33 manufacturers in China registered for Powder, Porcelain

Record

Regulatory record for Zolid Lunaris
Listed by Amann Girrbach AG, Austria
FDA product code EIH
Device type Powder, Porcelain
Device class Class 2
Regulation 21 CFR 872.6660
Establishment Private-label distributor, Complaint-file establishment, Manufacturer, Exporter
510(k) K260918
Record published 2026-07-02

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date, serial number
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Zolid Lunaris
Catalogue number Size Status
Zolid Lunaris A2 98×20 In distribution
Zolid Lunaris D2 98×12 In distribution
Zolid Lunaris BL0 98×12 In distribution
Zolid Lunaris BL4 98×12 In distribution
Zolid Lunaris BL3 98×16 In distribution
Zolid Lunaris A3,5 98×18 In distribution
Zolid Lunaris A3,5 98×30 In distribution
Zolid Lunaris BL2 98×20 In distribution
Zolid Lunaris BL2 98×14 In distribution
Zolid Lunaris C2 98×12 In distribution
Zolid Lunaris C2 98×18 In distribution
Zolid Lunaris A4 98×20 In distribution
Zolid Lunaris D2 98×25 In distribution
Zolid Lunaris BL0 98×16 In distribution
Zolid Lunaris BL4 98×30 In distribution
Zolid Lunaris A4 98×14 In distribution
Zolid Lunaris C1 98×18 In distribution
Zolid Lunaris C2 98×30 In distribution
Zolid Lunaris A3 98×20 In distribution
Zolid Lunaris D4 98×12 In distribution
Zolid Lunaris D3 98×16 In distribution
Zolid Lunaris A2 98×25 In distribution
Zolid Lunaris B2 98×14 In distribution
Zolid Lunaris BL0 98×14 In distribution
Zolid Lunaris D2 98×20 In distribution
Zolid Lunaris A3 98×12 In distribution
Zolid Lunaris B2 98×25 In distribution
Zolid Lunaris D4 98×20 In distribution
Zolid Lunaris D4 98×14 In distribution
Zolid Lunaris B4 98×16 In distribution
Zolid Lunaris A3,5 98×16 In distribution
Zolid Lunaris BL3 98×12 In distribution
Zolid Lunaris C1 98×14 In distribution
Zolid Lunaris BL2 98×30 In distribution
Zolid Lunaris B1 98×16 In distribution
Zolid Lunaris B2 98×18 In distribution
Zolid Lunaris BL4 98×18 In distribution
Zolid Lunaris C1 98×20 In distribution
Zolid Lunaris A3,5 98×12 In distribution
Zolid Lunaris B4 98×12 In distribution
Zolid Lunaris B3 98×25 In distribution
Zolid Lunaris C3 98×16 In distribution
Zolid Lunaris BL1 98×14 In distribution
Zolid Lunaris A3 98×30 In distribution
Zolid Lunaris D3 98×12 In distribution
Zolid Lunaris C3 98×25 In distribution
Zolid Lunaris BL0 98×18 In distribution
Zolid Lunaris B1 98×25 In distribution
Zolid Lunaris C4 98×25 In distribution
Zolid Lunaris D4 98×30 In distribution
Zolid Lunaris B3 98×20 In distribution
Zolid Lunaris A4 98×12 In distribution
Zolid Lunaris A4 98×16 In distribution
Zolid Lunaris A1 98×14 In distribution
Zolid Lunaris BL4 98×14 In distribution
Zolid Lunaris A4 98×18 In distribution
Zolid Lunaris C4 98×20 In distribution
Zolid Lunaris A2 98×16 In distribution
Zolid Lunaris BL3 98×25 In distribution
Zolid Lunaris B4 98×18 In distribution
Zolid Lunaris D3 98×14 In distribution
Zolid Lunaris A3 98×14 In distribution
Zolid Lunaris C4 98×16 In distribution
Zolid Lunaris BL0 98×25 In distribution
Zolid Lunaris C1 98×12 In distribution
Zolid Lunaris BL0 98×30 In distribution
Zolid Lunaris C1 98×30 In distribution
Zolid Lunaris BL1 98×20 In distribution
Zolid Lunaris B3 98×18 In distribution
Zolid Lunaris D3 98×18 In distribution
Zolid Lunaris C4 98×12 In distribution
Zolid Lunaris A1 98×12 In distribution
Zolid Lunaris A1 98×18 In distribution
Zolid Lunaris BL4 98×20 In distribution
Zolid Lunaris C1 98×25 In distribution
Zolid Lunaris C2 98×16 In distribution
Zolid Lunaris BL0 98×20 In distribution
Zolid Lunaris B4 98×14 In distribution
Zolid Lunaris BL1 98×18 In distribution
Zolid Lunaris A2 98×30 In distribution
Zolid Lunaris BL3 98×18 In distribution
Zolid Lunaris C3 98×30 In distribution
Zolid Lunaris BL3 98×14 In distribution
Zolid Lunaris A1 98×16 In distribution
Zolid Lunaris BL1 98×25 In distribution
Zolid Lunaris A4 98×30 In distribution
Zolid Lunaris B1 98×18 In distribution
Zolid Lunaris B2 98×12 In distribution
Zolid Lunaris C3 98×18 In distribution
Zolid Lunaris A1 98×30 In distribution
Zolid Lunaris B2 98×20 In distribution
Zolid Lunaris C3 98×14 In distribution
Zolid Lunaris D4 98×16 In distribution
Zolid Lunaris C1 98×16 In distribution
Zolid Lunaris B1 98×20 In distribution
Zolid Lunaris BL2 98×16 In distribution
Zolid Lunaris D3 98×20 In distribution
Zolid Lunaris BL1 98×16 In distribution
Zolid Lunaris BL2 98×18 In distribution
Zolid Lunaris BL3 98×30 In distribution
Zolid Lunaris D2 98×30 In distribution
Zolid Lunaris BL2 98×25 In distribution
Zolid Lunaris BL3 98×20 In distribution
Zolid Lunaris A3 98×16 In distribution
Zolid Lunaris C2 98×25 In distribution
Zolid Lunaris B4 98×30 In distribution
Zolid Lunaris BL4 98×16 In distribution
Zolid Lunaris B1 98×14 In distribution
Zolid Lunaris A2 98×12 In distribution
Zolid Lunaris A1 98×25 In distribution
Zolid Lunaris D4 98×18 In distribution
Zolid Lunaris D2 98×18 In distribution
Zolid Lunaris C4 98×30 In distribution
Zolid Lunaris A2 98×14 In distribution
Zolid Lunaris BL1 98×30 In distribution
Zolid Lunaris BL2 98×12 In distribution
Zolid Lunaris B3 98×14 In distribution
Zolid Lunaris D2 98×16 In distribution
Zolid Lunaris A1 98×20 In distribution
Zolid Lunaris D3 98×25 In distribution
Zolid Lunaris C3 98×20 In distribution
Zolid Lunaris BL1 98×12 In distribution
Zolid Lunaris A3,5 98×20 In distribution
Zolid Lunaris B3 98×16 In distribution
Zolid Lunaris D4 98×25 In distribution
Zolid Lunaris A4 98×25 In distribution
Zolid Lunaris D2 98×14 In distribution
Zolid Lunaris A3 98×18 In distribution
Zolid Lunaris B1 98×30 In distribution
Zolid Lunaris A3 98×25 In distribution
Zolid Lunaris A3,5 98×14 In distribution
Zolid Lunaris C4 98×18 In distribution
Zolid Lunaris B2 98×16 In distribution
Zolid Lunaris C2 98×14 In distribution
Zolid Lunaris B4 98×25 In distribution
Zolid Lunaris D3 98×30 In distribution
Zolid Lunaris B4 98×20 In distribution
Zolid Lunaris A2 98×18 In distribution
Zolid Lunaris C3 98×12 In distribution
Zolid Lunaris B3 98×12 In distribution
Zolid Lunaris B2 98×30 In distribution
Zolid Lunaris B1 98×12 In distribution
Zolid Lunaris A3,5 98×25 In distribution
Zolid Lunaris C4 98×14 In distribution
Zolid Lunaris C2 98×20 In distribution
Zolid Lunaris B3 98×30 In distribution
Zolid Lunaris BL4 98×25 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Bloomden Bloomden Bioceramics (Hunan) Co., Ltd. 6,340
Upcera Dental Zirconia Blank For Aesthetic Restoration Liaoning Upcera Co., Ltd. 4,367
Aidite Aidite (Qinhuangdao) Technology Co., Ltd. 4,310
Luxen 5G Dentalmax Co., Ltd. 3,903
GC Initial™ GC America Inc. 2,724
Gradual Dental Zirconia Blank Liaoning Upcera Co., Ltd. 2,035
Multi M Series Dmax Co., Ltd. 1,854
Zirconia Dental Ceramics Chengdu Besmile Medical Technology Co., Ltd. 1,828
Amber® Mill Q Hass Corp. 1,602
Upcera Dental Zirconia Pre-Shaded Blank Liaoning Upcera Co., Ltd. 1,498
BruxZir Prismatik Dentalcraft, Inc. 1,295
ceraMotion® Dentaurum GmbH & Co. KG 1,062

Showing 12 of 10,017. All products under Powder, Porcelain

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K260918 2026-06-29
K171876 2017-09-20

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer