Vita Enamic

VITA ENAMIC for KaVo ARCTICA, 1M1-HT, EM-14, 5 pcs. (1.010.1935)

Registry build 21.09.26
33manufacturers in China registered for this device type
259catalogue numbers in this listing

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 Vita Enamic
Listed by Vita – Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
FDA product code EIH
Device type Powder, Porcelain
Device class Class 2
Regulation 21 CFR 872.6660
510(k) K122269
Record published 2017-02-18
Record revised 2018-07-24 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, manufacturing date
Distribution end date 2017-02-17

Catalogue Numbers

Catalogue numbers for Vita Enamic
Catalogue number Size Status
ECDEM4981206 In distribution
EPMEM3282765 In distribution
EC42M2TEM14 In distribution
EA2M2HTEM145A In distribution
EN1EM7282765 In distribution
EC4EM7122765 In distribution
EC4EM7062765 In distribution
EC4EM4129485 In distribution
ECOEC4282765 In distribution
EN1EM30227630 In distribution
EC4EM3069605 In distribution
EPMEM3072765P In distribution
EA0EC4122765 In distribution
EGLEM4022765 In distribution
EPMEM3072765 In distribution
EN1EM4022645 In distribution
EC4EM3192765 In distribution
EPMEC4202765P In distribution
EA2M2TEM145 In distribution
EGLEM4062765 In distribution
EC4EM7122645 In distribution
EC4EM7072645 In distribution
EPMEC4282765 In distribution
EN1EC4072885 In distribution
EA1M2HTEM145A In distribution
EC4EM7282765 In distribution
EK1M1HTEM14K In distribution
EC43M2TEM14 In distribution
ECOEC4062765 In distribution
EPMEM4022765 In distribution
EC4EM14TSS In distribution
EPMEC4072765 In distribution
EPMEM4202645 In distribution
EC4EM3112765 In distribution
EA0EC4062765 In distribution
EC4EM4072765 In distribution
EC42M2HTEM14 In distribution
EPMEC4072765P In distribution
EC4EM4122765 In distribution
ECOEC4122765 In distribution
EN1EC41227630 In distribution
EK1M1HTEM14 In distribution
EK1M1TEM14K In distribution
EPMEM3022765 In distribution
EN1EM7072765 In distribution
ECDEM4981806 In distribution
EA2M2HTEM145 In distribution
EPMEM4072645 In distribution
EC4EM3209725 In distribution
EC41M2HTEM10 In distribution
EK2M2TEM14 In distribution
EN1EM30727630 In distribution
EGLEM4072765 In distribution
EC4EM4192765 In distribution
EPMEM4122765P In distribution
EPMEC4202765 In distribution
EN1EM3022765 In distribution
EPMEM4072645P In distribution
EPMEM3062765 In distribution
EK2M2HTEM14K In distribution
EN1EM4062765 In distribution
EC4EM3069725 In distribution
EN1EC4122885 In distribution
EC43M2HTEM10 In distribution
EC4EM4129365 In distribution
EC4EM4069485 In distribution
EN1EM4122765 In distribution
EPMEM3122765 In distribution
EPMEM4202645P In distribution
EC43M2HTEM14 In distribution
EN1EM32027630 In distribution
EC4EM3289605 In distribution
EK1M1TEM14 In distribution
ECDEM4981207 In distribution
EA0M1TEM145A In distribution
EC41M1TEM14 In distribution
EC4EM4062765 In distribution
EC4EMSTSETCV1 In distribution
EK0M1HTEM14K In distribution
EN1EM4022765 In distribution
EN1EC42027630 In distribution
EA0M1HTEM145A In distribution
EC4EM4289485 In distribution
EGLEM3062765 In distribution
EN1EM32827630 In distribution
EC4EM4079485 In distribution
EK1M2TEM14 In distribution
EA1M2HTEM145 In distribution
EC4EM4069365 In distribution
EA0EC4202765 In distribution
EPMEM4062765P In distribution
EC41M2TEM14 In distribution
EC4EM3132765 In distribution
EC41M1HTEM10 In distribution
EC40M1HTEM10 In distribution
EN1EM4062645 In distribution
EA3M2TEM145A In distribution
EC40M1HTEM14 In distribution
EPMEM4062645P In distribution
ECDEM4981807 In distribution
EKEMSTSETC In distribution
ECDEM4981812 In distribution
EK0M1HTEM14 In distribution
EC4EM14STSS In distribution
EGLEM3122765 In distribution
EN1EC4282885 In distribution
EA1M1TEM145A In distribution
EA0EC4282765 In distribution
EGLEM3072765 In distribution
EN1EC4062765 In distribution
EN1EC4072765 In distribution
EC4EM4132645 In distribution
EPMEM4022765P In distribution
EK2M2HTEM14 In distribution
EK1M2TEM14K In distribution
EA0EC4122765A In distribution
EC4EM7202645 In distribution
EPMEC4122765P In distribution
EC4EM4192645 In distribution
EK0M1TEM14K In distribution
EC4EM3209605 In distribution
ECDEM3981207 In distribution
EN1EM3282765 In distribution
EN1EM7062765 In distribution
EGLEM3022765 In distribution
EK0M1TEM14 In distribution
EN1EC42827630 In distribution
EN1EM4282645 In distribution
EA0M1HTEM145 In distribution
EC42M2HTEM10 In distribution
EC4EM4282645 In distribution
EN1EC4062885 In distribution
ECDEM4981220 In distribution
EN1EM31227630 In distribution
EC4EM3129605 In distribution
ECDEM3981812 In distribution
EN1EM7122765 In distribution
EN1EC40727630 In distribution
EN1EM40227630 In distribution
EA0EC4202765A In distribution
EN1EM4072645 In distribution
EN1EM41227630 In distribution
EN1EC4202765 In distribution
EK3M2HTEM14K In distribution
EPMEM4122765 In distribution
EC4EC4202885 In distribution
ECDEM4981228 In distribution
EC4EM7072765 In distribution
EA1M1HTEM145 In distribution
EC4EC4022765 In distribution
EC4EM4112645 In distribution
EC4EMC14HTSS In distribution
EPMEM4072765 In distribution
ECDEM4981212 In distribution
EPMEM4062765 In distribution
EPMEM4072765P In distribution
EC4EM14HTSS In distribution
EGLEM3202765 In distribution
EN1EM4202645 In distribution
EC4EM3079605 In distribution
EC4EC4202765 In distribution
EC41M1HTEM14 In distribution
EPMEM3202765P In distribution
EA0M1TEM145 In distribution
EC4EM4202765 In distribution
EA0EC4072765 In distribution
EC4EC4122885 In distribution
EC4EM4112765 In distribution
EN1EC4282765 In distribution
ECOEC4202765 In distribution
EC4EM3282765 In distribution
EN1EC4202885 In distribution
EC4EC4062765 In distribution
EC4EM4289365 In distribution
EC4EC4122765 In distribution
EC4EM4022765 In distribution
EK3M2HTEM14 In distribution
EA0EC4282765A In distribution
EC4EM4212645 In distribution
EA3M2HTEM145 In distribution
EPMEM3022765P In distribution
EA1M2TEM145A In distribution
ECDEM3981212 In distribution
EN1EM3062765 In distribution
EN1EM30627630 In distribution
EA3M2HTEM145A In distribution
ECDEM3981807 In distribution
EC4EM4209365 In distribution
EC4EC4282765 In distribution
EN1EM3202765 In distribution
EK3M2TEM14K In distribution
EPMEM4202765P In distribution
EPMEM4022645P In distribution
EC4EC4282885 In distribution
EC4EM4132765 In distribution
EN1EC4122765 In distribution
EC4EM3129725 In distribution
EA3M2TEM145 In distribution
EC4EM3289725 In distribution
EN1EM4202765 In distribution
EA2M2TEM145A In distribution
EPMEC4282765P In distribution
EPMEM4122645P In distribution
EPMEM4282765 In distribution
EN1EM4282765 In distribution
EN1EM40727630 In distribution
EN1EM42027630 In distribution
EPMEM3202765 In distribution
EC4EM7282645 In distribution
EPMEM3282765P In distribution
EC4EC4072885 In distribution
ECDEM4981820 In distribution
EN1EC40627630 In distribution
EGLEM4202765 In distribution
EPMEC4062765P In distribution
EN1EM4122645 In distribution
ECDEM3981220 In distribution
EC4EM4212765 In distribution
EC4EC4072765 In distribution
EA1M2TEM145 In distribution
EPMEM3122765P In distribution
EC4EM4079365 In distribution
EN1EM3122765 In distribution
EPMEM4282765P In distribution
EPMEM4202765 In distribution
EA1M1TEM145 In distribution
EPMEM4062645 In distribution
EC4EM3212765 In distribution
EKEMSTSETCK In distribution
EC40M1TEM14 In distribution
EPMEM3062765P In distribution
EK3M2TEM14 In distribution
EC4EM3079725 In distribution
EA0EC4062765A In distribution
EN1EM42827630 In distribution
EC4EM4209485 In distribution
ECOEC4072765 In distribution
EC4EC4062885 In distribution
EPMEC4122765 In distribution
EA0EC4072765A In distribution
EK1M2HTEM14K In distribution
EN1EM4072765 In distribution
EC4EM7202765 In distribution
EN1EM40627630 In distribution
EK1M2HTEM14 In distribution
EPMEC4062765 In distribution
EPMEM4122645 In distribution
EC4EM4282765 In distribution
EA1M1HTEM145A In distribution
EC41M2HTEM14 In distribution

Showing 250 of 259 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
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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

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