Biotem

Biotem AR TRANSFER IMPRESSION COPING(NON-HEX) 4.0 mm (D) X 11.0 mm (L)

Registry build 21.09.26
70manufacturers in China registered for this device type
76catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (28), Jiangsu (9), Zhejiang (6). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code NDP
Manufacturer City Province Registered as Device types
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
LX Precision Shanghai Co Ltd Shanghai Shanghai Contract manufacturer 19
iBrite Suzhou Technology Co., Ltd. Suzhou Jiangsu Contract manufacturer 18
Digital Dental Depot Zhuhai Guangdong Contract manufacturer 17
Xiamen Yizhou IMP. & EXP. Co., Ltd. Xiamen Fujian Contract manufacturer 10
Amedcon Medical Technology (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 7
Ningbo Sezen Technology Co., Ltd. Ningbo Zhejiang Contract manufacturer 7
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Shanghai Jolly Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 99
Shanghai Lions Industrial Co., Ltd. Shanghai Shanghai Contract manufacturer 82
Wuxi Lyusmile IMP AND EXP Co., Ltd. Wuxi Jiangsu Private-label distributor 66

Showing 12 of 70. All 70 manufacturers in China registered for Accessories, Implant, Dental, Endosseous

Record

Regulatory record for Biotem
Listed by Biotem Co., Ltd., South Korea
FDA product code NDP
Device type Accessories, Implant, Dental, Endosseous
Device class Class 1
Regulation 21 CFR 872.3980
Establishment Manufacturer
Premarket notification Exempt
Record published 2018-05-31

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Radiation Sterilization
Single use Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date, serial number
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Biotem
Catalogue number Size Status
LAAS5507 In distribution
LAIF6015W In distribution
IPI4808M In distribution
LAIS48357 In distribution
LAAS6504 In distribution
LAT5015 In distribution
LAIS607EW In distribution
HDB0915 In distribution
LAAS6505 In distribution
LAAF4015 In distribution
LAIF4815M In distribution
ITB4108T In distribution
IAT4011MN In distribution
LAAS4505 In distribution
IAT6011S In distribution
IAT4011SN In distribution
LAAS5505 In distribution
LAIS48354 In distribution
LAB5015 In distribution
LAIS4855 In distribution
ITB3508T In distribution
LAAF3715 In distribution
IPB40512 In distribution
IAT4011M In distribution
LAIS605EW In distribution
IAT4011S In distribution
LAAS4504 In distribution
IPB35412 In distribution
IPB50612 In distribution
LAIF4815 In distribution
IAT4014M In distribution
LAB4015 In distribution
LAIS4854 In distribution
IPA4810N In distribution
TRA45 In distribution
IPA4813N In distribution
IPA5810N In distribution
IAT4014MN In distribution
IAT4014SN In distribution
IPA3413 In distribution
SD12RS In distribution
IPA4810 In distribution
LAAS6507 In distribution
IAT6011SN In distribution
ITB5108T In distribution
IPI6012EW In distribution
IPI4812 In distribution
HDB0908 In distribution
ITB5111T In distribution
IAT4014S In distribution
IPA3410 In distribution
ITB3511T In distribution
IAT5014SN In distribution
IPA5810 In distribution
LAAF3415 In distribution
IAT6014SN In distribution
LAB5018 In distribution
LAAS5504 In distribution
IAT5011SN In distribution
IPI4808 In distribution
LAIS4857 In distribution
LAB3515 In distribution
ITB4111T In distribution
IPA3413N In distribution
LAAS4507 In distribution
LAB4018 In distribution
IPI6008EW In distribution
LAIS604EW In distribution
IAT5014S In distribution
IPA3410N In distribution
SD12RL In distribution
IAT5011S In distribution
IAT6014S In distribution
LAIS48355 In distribution
IPI4812M In distribution
IPA4813 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Accessories, Implant, Dental, Endosseous Southern Implants (PTY) Ltd 1,379
Accessories, Implant, Dental, Endosseous Institut Straumann AG 1,320
Neobiotech Implant System Neobiotech Co., Ltd. 1,112
Inclusive Prismatik Dentalcraft, Inc. 1,045
Medentika Medentika GmbH 1,042
BioHorizons Biohorizons Implant Systems Inc. 1,008
IPD Implant Protesis Dental 2004 SL 998
Klockner Soadco, S.L. 995
Dynamic Abutment Solutions Talladium España, SL 877
Neodent Jjgc Indústria e Comércio de Materiais Dentários S.A. 738
Nobel Biocare® Nobel Biocare AB 703
MIS MIS Implants Technologies Ltd. 615

Showing 12 of 7,548. All products under Accessories, Implant, Dental, Endosseous

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