NobelReplace®

Guided Implant Mount NobelReplace® Conical Connection NP 3.5

Registry build 21.09.26
70manufacturers in China registered for this device type
314catalogue 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 NobelReplace®
Listed by Nobel Biocare AB, Sweden
FDA product code NDP
Device type Accessories, Implant, Dental, Endosseous
Device class Class 1
Regulation 21 CFR 872.3980
Establishment Specification developer, Manufacturer
Premarket notification Exempt
Record published 2023-02-15
Record revised 2025-07-07 (version 9)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
Storage Special storage condition: Keep away from sunlight. Keep dry
Sizes Outer diameter 2 to 7 mm; length 8 to 30 mm
Distribution end date 2025-02-05
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for NobelReplace®
Catalogue number Size Per pack Status
31151 Length 20.000 mm In distribution
37090 Outer Diameter 6.000 mm In distribution
33468 Outer Diameter 5.000 mm In distribution
29120 5 In distribution
33466 Outer Diameter 4.500 mm In distribution
37089 Length 8.000 mm In distribution
29367 Length 10.000 mm In distribution
29119 5 In distribution
37090 Length 10.000 mm In distribution
37092 Length 13.000 mm In distribution
32869 In distribution
32250 Outer Diameter 6.000 mm In distribution
37085 Length 10.000 mm In distribution
29493 Outer Diameter 6.000 mm In distribution
37097 Length 16.000 mm In distribution
37149 Outer Diameter 3.500 mm In distribution
37082 Outer Diameter 4.300 mm In distribution
36114 Length 11.500 mm In distribution
32075 Outer Diameter 3.500 mm In distribution
32294 Outer Diameter 6.000 mm In distribution
32249 Length 16.000 mm In distribution
29498 In distribution
32869 In distribution
29121 5 In distribution
37098 Outer Diameter 5.000 mm In distribution
36117 Outer Diameter 2.000 mm In distribution
31170 In distribution
32769 In distribution
29967 Length 10.000 mm In distribution
36126 In distribution
32885 Length 28.000 mm In distribution
37151 Outer Diameter 5.000 mm In distribution
37076 Outer Diameter 3.500 mm In distribution
31167 In distribution
37098 Outer Diameter 5.000 mm In distribution
36125 In distribution
37045 Outer Diameter 3.500 mm In distribution
37167 Outer Diameter 3.500 mm In distribution
36124 In distribution
29369 Outer Diameter 3.500 mm In distribution
36126 In distribution
32180 In distribution
32295 Outer Diameter 6.000 mm In distribution
29377 Outer Diameter 3.500 mm In distribution
32741 In distribution
29375 Length 16.000 mm In distribution
36130 Outer Diameter 6.000 mm In distribution
29381 Outer Diameter 4.300 mm In distribution
32737 In distribution
37099 Outer Diameter 5.000 mm In distribution
37150 Outer Diameter 4.300 mm In distribution
32885 Length 28.000 mm In distribution
29372 Length 16.000 mm In distribution
37079 Length 8.000 mm In distribution
37091 Length 11.500 mm In distribution
33539 Outer Diameter 4.300 mm In distribution
37168 Outer Diameter 4.300 mm In distribution
29485 Outer Diameter 3.500 mm In distribution
33065 In distribution
37170 Outer Diameter 6.000 mm In distribution
32739 In distribution
37095 Outer Diameter 3.500 mm In distribution
36831 Outer Diameter 5.300 mm In distribution
29371 Outer Diameter 4.300 mm In distribution
29502 In distribution
32808 In distribution
32294 Outer Diameter 6.000 mm In distribution
36127 In distribution
32078 Length 8.000 mm In distribution
36830 Outer Diameter 4.600 mm In distribution
36830 Outer Diameter 4.600 mm In distribution
37078 Outer Diameter 3.500 mm In distribution
29384 Outer Diameter 5.000 mm In distribution
37093 Length 16.000 mm In distribution
37095 Length 16.000 mm In distribution
37075 Outer Diameter 3.500 mm In distribution
36715 In distribution
29500 In distribution
37075 Outer Diameter 3.500 mm In distribution
37083 Length 16.000 mm In distribution
32075 Outer Diameter 3.500 mm In distribution
36113 Length 11.500 mm In distribution
29384 Outer Diameter 5.000 mm In distribution
36129 In distribution
32808 In distribution
28839 In distribution
36131 Outer Diameter 6.000 mm In distribution
36115 Outer Diameter 5.000 mm In distribution
32811 Outer Diameter 6.000 mm In distribution
32771 In distribution
37099 Length 16.000 mm In distribution
29372 Length 16.000 mm In distribution
32882 Length 28.000 mm In distribution
29120 5 In distribution
36116 Length 11.500 mm In distribution
29368 Outer Diameter 3.500 mm In distribution
32864 In distribution
29381 Length 16.000 mm In distribution
36114 Length 11.500 mm In distribution
29370 Length 10.000 mm In distribution
29370 Outer Diameter 4.300 mm In distribution
36832 Outer Diameter 6.500 mm In distribution
29380 Length 13.000 mm In distribution
29498 In distribution
29502 In distribution
31152 Length 20.000 mm In distribution
37089 Outer Diameter 6.000 mm In distribution
37088 Outer Diameter 5.000 mm In distribution
37170 Outer Diameter 6.000 mm In distribution
36127 In distribution
33539 Outer Diameter 4.300 mm In distribution
37081 Outer Diameter 4.300 mm In distribution
37096 Outer Diameter 4.300 mm In distribution
37320 In distribution
32077 Outer Diameter 5.000 mm In distribution
29383 Length 13.000 mm In distribution
37084 Length 8.000 mm In distribution
36129 In distribution
37169 Outer Diameter 5.000 mm In distribution
29383 Outer Diameter 5.000 mm In distribution
36116 Outer Diameter 6.000 mm In distribution
29374 Length 13.000 mm In distribution
37087 Outer Diameter 5.000 mm In distribution
33505 Outer Diameter 7.000 mm In distribution
29377 Length 13.000 mm In distribution
37086 Outer Diameter 5.000 mm In distribution
37087 Length 13.000 mm In distribution
32295 Outer Diameter 6.000 mm In distribution
29967 Length 10.000 mm In distribution
37088 Outer Diameter 5.000 mm In distribution
29119 5 In distribution
36128 In distribution
37076 Outer Diameter 3.500 mm In distribution
33466 Outer Diameter 4.500 mm In distribution
29374 Length 13.000 mm In distribution
33467 Outer Diameter 5.300 mm In distribution
36130 Outer Diameter 6.000 mm In distribution
29121 5 In distribution
29293 5 In distribution
32741 In distribution
32882 Length 28.000 mm In distribution
37084 Length 8.000 mm In distribution
37093 Length 16.000 mm In distribution
31167 In distribution
37085 Outer Diameter 5.000 mm In distribution
32866 In distribution
31152 Length 20.000 mm In distribution
37080 Length 10.000 mm In distribution
37151 Outer Diameter 5.000 mm In distribution
37094 Outer Diameter 3.500 mm In distribution
32077 Length 8.000 mm In distribution
33065 In distribution
29367 Outer Diameter 3.500 mm In distribution
32880 Length 28.000 mm In distribution
36115 Length 11.500 mm In distribution
32803 In distribution
32076 Outer Diameter 4.300 mm In distribution
37086 Length 11.500 mm In distribution
37167 Outer Diameter 3.500 mm In distribution
29371 Length 13.000 mm In distribution
30039 Outer Diameter 6.000 mm In distribution
37081 Outer Diameter 4.300 mm In distribution
32249 Length 16.000 mm In distribution
36124 In distribution
37083 Length 16.000 mm In distribution
29368 Outer Diameter 3.500 mm In distribution
32864 In distribution
37092 Length 13.000 mm In distribution
33095 In distribution
29968 Length 13.000 mm In distribution
32778 Outer Diameter 6.000 mm In distribution
37078 Length 16.000 mm In distribution
29375 Outer Diameter 5.000 mm In distribution
37082 Length 13.000 mm In distribution
32775 In distribution
37168 Outer Diameter 4.300 mm In distribution
32871 Outer Diameter 6.000 mm In distribution
37091 Outer Diameter 6.000 mm In distribution
36832 Outer Diameter 6.500 mm In distribution
29485 Outer Diameter 3.500 mm In distribution
32803 In distribution
36131 Outer Diameter 6.000 mm In distribution
30043 5 In distribution
37094 Length 13.000 mm In distribution
28840 In distribution
29995 Outer Diameter 6.000 mm In distribution
32778 Outer Diameter 6.000 mm In distribution
37077 Outer Diameter 3.500 mm In distribution
31166 In distribution
36831 Outer Diameter 5.300 mm In distribution
29369 Length 16.000 mm In distribution
31151 Length 20.000 mm In distribution
37049 Length 16.000 mm In distribution
29970 Length 13.000 mm In distribution
29373 Outer Diameter 5.000 mm In distribution
37096 Outer Diameter 4.300 mm In distribution
29970 Outer Diameter 6.000 mm In distribution
36125 In distribution
30039 Outer Diameter 6.000 mm In distribution
37097 Outer Diameter 4.300 mm In distribution
32769 In distribution
29373 Length 10.000 mm In distribution
29995 Outer Diameter 6.000 mm In distribution
32805 In distribution
37045 Length 8.000 mm In distribution
28840 In distribution
36117 Outer Diameter 2.000 mm In distribution
37079 Outer Diameter 4.300 mm In distribution
36128 In distribution
32739 In distribution
31170 In distribution
37049 Outer Diameter 6.000 mm In distribution
32871 Outer Diameter 6.000 mm In distribution
32805 In distribution
37048 Length 13.000 mm In distribution
32743 Outer Diameter 6.000 mm In distribution
32743 Outer Diameter 6.000 mm In distribution
32250 Outer Diameter 6.000 mm In distribution
37149 Outer Diameter 3.500 mm In distribution
33469 Outer Diameter 7.000 mm In distribution
32811 Outer Diameter 6.000 mm In distribution
29493 Outer Diameter 6.000 mm In distribution
33468 Outer Diameter 5.000 mm In distribution
29378 Length 16.000 mm In distribution
29500 In distribution
29380 Outer Diameter 4.300 mm In distribution
29378 Outer Diameter 3.500 mm In distribution
31153 Length 30.000 mm In distribution
37048 Outer Diameter 6.000 mm In distribution
36113 Outer Diameter 3.500 mm In distribution
31166 In distribution
32737 In distribution
31153 Length 30.000 mm In distribution
33467 Outer Diameter 5.300 mm In distribution
33469 Outer Diameter 7.000 mm In distribution
32078 Outer Diameter 6.000 mm In distribution
37169 Outer Diameter 5.000 mm In distribution
32775 In distribution
37077 Outer Diameter 3.500 mm In distribution
37150 Outer Diameter 4.300 mm In distribution
29968 Outer Diameter 6.000 mm In distribution
32880 Length 28.000 mm In distribution
37080 Outer Diameter 4.300 mm In distribution
29293 5 In distribution
32771 In distribution
33505 Outer Diameter 7.000 mm In distribution
32866 In distribution
32076 Outer Diameter 4.300 mm In distribution
32769 Withdrawn
32900 Withdrawn

Showing 250 of 300 catalogue numbers.

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