Dental › MiscellaneousPowder, Porcelain

Straumann® Variobase® Abutments and Straumann® N!ce® Zirconia Discs

n!ce® ZirconiaLT, Full-Arch Restoration, %%MATERIALCOLORSTRING%%

Registry build 21.09.26
33manufacturers in China registered for this device type
246catalogue numbers in this listing
3510(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 Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs
Listed by Institut Straumann AG, Switzerland
FDA product code EIH
Device type Powder, Porcelain
Device class Class 2
Regulation 21 CFR 872.6660
Establishment Specification developer, Complaint-file establishment, Manufacturer, Exporter
Record published 2023-05-26
Record revised 2026-06-10 (version 4)

Specifications

Specifications
MRI safety MR Conditional
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date, serial number
Sizes Height 12 to 30 mm
Distribution end date 2026-04-29

Catalogue Numbers

Catalogue numbers for Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs
Catalogue number Size Status
Milling Materials Height 14 mm In distribution
Milling Materials Height 16 mm In distribution
Bridges (tooth borne) In distribution
Milling Materials Height 16 mm In distribution
Milling Materials Height 14 mm In distribution
Milling Materials Height 12 mm In distribution
Milling Materials Height 25 mm In distribution
Milling Materials Height 20 mm In distribution
Milling Materials Height 20 mm In distribution
Milling Materials Height 25 mm In distribution
Milling Materials Height 25 mm In distribution
Milling Materials Height 14 mm In distribution
Crowns In distribution
Milling Materials Height 25 mm In distribution
Milling Materials Height 16 mm In distribution
Milling Materials Height 16 mm In distribution
Bridges (tooth borne) In distribution
Milling Materials Height 20 mm In distribution
Milling Materials Height 14 mm In distribution
Bridges (tooth borne) In distribution
Milling Materials Height 16 mm In distribution
Milling Materials Height 14 mm In distribution
Milling Materials Height 16 mm In distribution
Bridges (tooth borne) In distribution
Milling Materials Height 30 mm In distribution
Bridges (tooth borne) In distribution
Bridges (tooth borne) In distribution
Milling Materials Height 16 mm In distribution
Milling Materials Height 25 mm In distribution
Milling Materials Height 25 mm In distribution
Milling Materials Height 25 mm In distribution
Milling Materials Height 18 mm In distribution
Milling Materials Height 14 mm In distribution
Bridges (tooth borne) In distribution
Milling Materials Height 25 mm In distribution
Milling Materials Height 20 mm In distribution
Milling Materials Height 20 mm In distribution
Bridges (tooth borne) In distribution
Bridges (tooth borne) In distribution
Milling Materials Height 30 mm In distribution
Milling Materials Height 25 mm In distribution
Milling Materials Height 14 mm In distribution
Milling Materials Height 20 mm In distribution
Milling Materials Height 16 mm In distribution
Milling Materials Height 16 mm In distribution
Milling Materials Height 20 mm In distribution
Milling Materials Height 20 mm In distribution
Milling Materials Height 14 mm In distribution
Milling Materials Height 20 mm In distribution
Milling Materials Height 20 mm In distribution
Milling Materials Height 16 mm In distribution
Bridges (tooth borne) In distribution
Milling Materials Height 25 mm In distribution
Milling Materials Height 14 mm In distribution
Milling Materials Height 20 mm In distribution
Milling Materials Height 14 mm In distribution
Bridges (tooth borne) In distribution
Milling Materials Height 25 mm In distribution
Milling Materials Height 16 mm In distribution
Milling Materials Height 14 mm In distribution
Milling Materials Height 20 mm In distribution
Milling Materials Height 25 mm In distribution
Milling Materials Height 25 mm In distribution
Milling Materials Height 14 mm In distribution
Milling Materials Height 14 mm In distribution
Milling Materials Height 20 mm In distribution
Milling Materials Height 14 mm In distribution
Milling Materials Height 25 mm In distribution
Milling Materials Height 25 mm In distribution
Milling Materials Height 30 mm In distribution
Milling Materials Height 16 mm In distribution
Milling Materials Height 25 mm In distribution
Milling Materials Height 20 mm In distribution
Milling Materials Height 20 mm In distribution
Milling Materials Height 14 mm In distribution
Milling Materials Height 25 mm In distribution
Bridges (tooth borne) In distribution
Bridges (tooth borne) In distribution
Milling Materials Height 20 mm In distribution
Bridges (tooth borne) In distribution
Milling Materials Height 20 mm In distribution
Milling Materials Height 25 mm In distribution
Milling Materials Height 20 mm In distribution
Bridges (tooth borne) In distribution
Bridges (tooth borne) In distribution
Milling Materials Height 30 mm In distribution
Milling Materials Height 14 mm In distribution
Milling Materials Height 16 mm In distribution
Milling Materials Height 16 mm In distribution
Milling Materials Height 20 mm In distribution
Milling Materials Height 25 mm In distribution
Milling Materials Height 25 mm In distribution
Milling Materials Height 14 mm In distribution
Milling Materials Height 30 mm In distribution
Milling Materials Height 30 mm In distribution
Milling Materials Height 25 mm In distribution
Milling Materials Height 16 mm In distribution
Milling Materials Height 20 mm In distribution
Milling Materials Height 25 mm In distribution
Milling Materials Height 14 mm In distribution
Milling Materials Height 20 mm In distribution
Milling Materials Height 30 mm In distribution
Milling Materials Height 16 mm In distribution
Milling Materials Height 16 mm In distribution
Milling Materials Height 20 mm In distribution
Milling Materials Height 25 mm In distribution
Milling Materials Height 18 mm In distribution
Milling Materials Height 14 mm In distribution
Milling Materials Height 20 mm In distribution
Milling Materials Height 20 mm In distribution
Milling Materials Height 14 mm In distribution
Milling Materials Height 20 mm In distribution
Milling Materials Height 25 mm In distribution
Milling Materials Height 14 mm In distribution
Bridges (tooth borne) In distribution
Milling Materials Height 25 mm In distribution
Milling Materials Height 16 mm In distribution
Milling Materials Height 16 mm In distribution
Milling Materials Height 14 mm In distribution
Bridges (tooth borne) In distribution
Milling Materials Height 14 mm In distribution
Milling Materials Height 30 mm In distribution
Milling Materials Height 30 mm In distribution
Milling Materials Height 16 mm In distribution
Bridges (tooth borne) In distribution
Milling Materials Height 14 mm In distribution
Milling Materials Height 14 mm In distribution
Bridges (tooth borne) In distribution
Milling Materials Height 16 mm In distribution
Milling Materials Height 14 mm In distribution
Milling Materials Height 20 mm In distribution
Milling Materials Height 16 mm In distribution
Bridges (tooth borne) In distribution
Milling Materials Height 14 mm In distribution
Milling Materials Height 16 mm In distribution
Milling Materials Height 14 mm In distribution
Milling Materials Height 14 mm In distribution
Milling Materials Height 25 mm In distribution
Milling Materials Height 20 mm In distribution
Milling Materials Height 16 mm In distribution
Milling Materials Height 25 mm In distribution
Milling Materials Height 20 mm In distribution
Milling Materials Height 16 mm In distribution
Milling Materials Height 14 mm In distribution
Milling Materials Height 25 mm In distribution
Milling Materials Height 25 mm In distribution
Milling Materials Height 14 mm In distribution
Milling Materials Height 20 mm In distribution
Bridges (tooth borne) In distribution
Milling Materials Height 14 mm In distribution
Milling Materials Height 16 mm In distribution
Milling Materials Height 30 mm In distribution
Bridges (tooth borne) In distribution
Milling Materials Height 20 mm In distribution
Milling Materials Height 16 mm In distribution
Milling Materials Height 14 mm In distribution
Milling Materials Height 30 mm In distribution
Milling Materials Height 20 mm In distribution
Milling Materials Height 20 mm In distribution
Milling Materials Height 30 mm In distribution
Bridges (tooth borne) In distribution
Milling Materials Height 20 mm In distribution
Milling Materials Height 16 mm In distribution
Milling Materials Height 30 mm In distribution
Bridges (tooth borne) In distribution
Milling Materials Height 25 mm In distribution
Milling Materials Height 25 mm In distribution
Milling Materials Height 20 mm In distribution
Milling Materials Height 25 mm In distribution
Milling Materials Height 14 mm In distribution
Bridges (tooth borne) In distribution
Milling Materials Height 20 mm In distribution
Bridges (tooth borne) In distribution
Milling Materials Height 14 mm In distribution
Milling Materials Height 30 mm In distribution
Milling Materials Height 25 mm In distribution
Milling Materials Height 16 mm In distribution
Milling Materials Height 20 mm In distribution
Bridges (tooth borne) In distribution
Milling Materials Height 30 mm In distribution
Milling Materials Height 20 mm In distribution
Milling Materials Height 14 mm In distribution
Bridges (tooth borne) In distribution
Milling Materials Height 20 mm In distribution
Milling Materials Height 16 mm In distribution
Milling Materials Height 14 mm In distribution
Milling Materials Height 20 mm In distribution
Milling Materials Height 25 mm In distribution
Milling Materials Height 16 mm In distribution
Milling Materials Height 30 mm In distribution
Milling Materials Height 25 mm In distribution
Bridges (tooth borne) In distribution
Milling Materials Height 20 mm In distribution
Bridges (tooth borne) In distribution
Milling Materials Height 14 mm In distribution
Milling Materials Height 16 mm In distribution
Milling Materials Height 16 mm In distribution
Milling Materials Height 16 mm In distribution
Bridges (tooth borne) In distribution
Milling Materials Height 16 mm In distribution
Milling Materials Height 14 mm In distribution
Milling Materials Height 16 mm In distribution
Milling Materials Height 20 mm In distribution
Milling Materials Height 25 mm In distribution
Milling Materials Height 12 mm In distribution
Milling Materials Height 16 mm In distribution
Milling Materials Height 30 mm In distribution
Milling Materials Height 14 mm In distribution
Milling Materials Height 30 mm In distribution
Milling Materials Height 16 mm In distribution
Milling Materials Height 18 mm In distribution
Milling Materials Height 14 mm In distribution
Milling Materials Height 16 mm In distribution
Milling Materials Height 20 mm In distribution
Milling Materials Height 30 mm In distribution
Milling Materials Height 30 mm In distribution
Milling Materials Height 12 mm In distribution
Milling Materials Height 30 mm In distribution
Milling Materials Height 20 mm In distribution
Crowns In distribution
Milling Materials Height 14 mm In distribution
Milling Materials Height 16 mm In distribution
Milling Materials Height 14 mm In distribution
Bridges (tooth borne) In distribution
Milling Materials Height 30 mm In distribution
Milling Materials Height 20 mm In distribution
Bridges (tooth borne) In distribution
Milling Materials Height 14 mm In distribution
Milling Materials Height 30 mm In distribution
Milling Materials Height 30 mm In distribution
Milling Materials Height 25 mm In distribution
Milling Materials Height 16 mm In distribution
Milling Materials Height 30 mm In distribution
Milling Materials Height 16 mm In distribution
Milling Materials Height 30 mm In distribution
Milling Materials Height 16 mm In distribution
Milling Materials Height 14 mm In distribution
Milling Materials Height 30 mm In distribution
Milling Materials Height 20 mm In distribution
Crowns In distribution
Milling Materials Height 25 mm In distribution
Milling Materials Height 30 mm In distribution
Milling Materials Height 16 mm In distribution
Milling Materials Height 16 mm Withdrawn
Milling Materials Height 30 mm Withdrawn
Milling Materials Height 25 mm Withdrawn

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
K173410 2017-11-14
K170420 2017-03-02
K160262 2016-09-16

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs
Recalled by Identified by Initiated FDA class Root cause Reason Quantity
Straumann USA, LLC UDI-DI 2026-03-27 Class II Under Investigation by firm Includes an incorrect screw seat interface. 6 units

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