Who else makes this device?

Name: edelweiss CAD/CAM C-Block A0 (10/12/16)
Brand: edelweiss CAD/CAM C-Block A0 (10/12/16)

Edelweiss CAD/CAM C-Block A0 (10/12/16) · Material, Tooth Shade, Resin → Dental

10manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Guangdong (3), Shandong (2), Jilin (2).

Chinese manufacturers registered for FDA product code EBF
Manufacturer	City	Province	Registered as	Device types
Aidite (Qinhuangdao) Technology Co., Ltd.	Qinhuangdao	Hebei	Repacker / relabeller	17
Shandong Huge Dental Material Corporation	Rizhao	Shandong	Manufacturer	17
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
Hangzhou SHINING3D Dental Technology Co., Ltd.	Hangzhou	Zhejiang	Manufacturer	7
Shenzhen Piocreat 3D Technology Co., Ltd.	Shenzhen	Guangdong	Manufacturer	6
Shenzhen Upcera Dental Technology Co., Ltd.	Shenzhen	Guangdong	Private-label distributor	6
Sincera Technology (Changchun) Co., Ltd.	Changchun	Jilin	Manufacturer	2
Sino-Dentex Co., Ltd.	Changchun	Jilin	Manufacturer	2

Record

Regulatory record for edelweiss CAD/CAM C-Block A0 (10/12/16)
Listed by	Edelweiss Dentistry Products Gmbh, Austria
FDA product code	EBF
Device type	Material, Tooth Shade, Resin
Device class	Class 2
Regulation	21 CFR 872.3690
Establishment	Contract manufacturer, Manufacturer
510(k)	K241131
Record published	2024-11-04

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for edelweiss CAD/CAM C-Block A0 (10/12/16)
Catalogue number	Size	Status
21101		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Tooth Shade Resin Material	Liaoning Upcera Co., Ltd.	4,808
Gradia®	GC America Inc.	548
G-CAM	Graphenano Dental, SL	320
Vitavm LC	Vita – Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft	261
G-aenial™	GC America Inc.	225
Ena HRI ®	Micerium SPA	221
Mazic Duro	Vericom Co., Ltd.	206
Ceramage	Shofu Dental Corp.	204
Filtek™	3M Company	188
SR Nexco	Ivoclar Vivadent Aktiengesellschaft	181
Aidite	Aidite (Qinhuangdao) Technology Co., Ltd.	166
Tetric EvoCeram	Ivoclar Vivadent Aktiengesellschaft	163

Showing 12 of 2,059. All products under Material, Tooth Shade, Resin

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K241131	2024-10-18

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.

Edelweiss CAD/CAM C-Block A0 (10/12/16)