Neodent

ZI Transmucosal Hybrid Repositionable Universal Base Analog, D 5.5X4

Registry build 21.09.26
70manufacturers in China registered for this device type
738catalogue 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 Neodent
Listed by Jjgc Indústria e Comércio de Materiais Dentários S.A., Brazil
FDA product code NDP
Device type Accessories, Implant, Dental, Endosseous
Device class Class 1
Regulation 21 CFR 872.3980
Premarket notification Exempt
Record published 2022-12-13
Record revised 2023-12-21 (version 5)

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, serial number
Storage Storage environment temperature up to 40 °C; Special storage condition: Protect from Sunlight
Sizes Outer diameter 0.9 to 7.9 mm; height 0.8 to 13 mm; length 4 to 291.5 mm; lumen/inner diameter 4.3 to 7.1 mm; angle 17 to 52 °
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Neodent
Catalogue number Size Status
111.046 Outer Diameter 3.75 mm In distribution
125.217-ET In distribution
108.225 In distribution
103.515 Outer Diameter 4 mm In distribution
103.569 Outer Diameter 4 mm In distribution
102.141 In distribution
130.108 In distribution
118.303 Outer Diameter 4.1 mm In distribution
105.148 In distribution
114.337 Outer Diameter 3.5 mm In distribution
108.162 In distribution
105.174 Length 15 mm In distribution
103.593 In distribution
118.034 In distribution
101.088 In distribution
108.182 In distribution
103.623 Outer Diameter 3.75 mm In distribution
103.517 Outer Diameter 5 mm In distribution
103553 Outer Diameter 3.5 mm In distribution
101.028 In distribution
114.774 Height 2.5 mm In distribution
111.036 Outer Diameter 3.5 mm In distribution
114.795 Outer Diameter 4.5 mm In distribution
103.509 Outer Diameter 5 mm In distribution
103.501 Outer Diameter 3.75 mm In distribution
103.030 Outer Diameter 4.1 mm In distribution
103540 Outer Diameter 4.3 mm In distribution
105.130 In distribution
123.003 In distribution
103.628 Outer Diameter 7.0 mm In distribution
118.233 Outer Diameter 4.1 mm In distribution
105.129 In distribution
118.301 In distribution
125.217 In distribution
105.175 Length 23 mm In distribution
125.136 In distribution
108.104 Outer Diameter 5 mm In distribution
103545 Outer Diameter 2 mm In distribution
108.224 In distribution
114.451 Outer Diameter 2.5 mm In distribution
103.565 Outer Diameter 3.75 mm In distribution
103.582 Outer Diameter 5 mm In distribution
125.128 Outer Diameter 6 mm In distribution
128.039 In distribution
108.069 In distribution
114.222 Outer Diameter 3.3 mm In distribution
114.197 Outer Diameter 3.3 mm In distribution
104.072 In distribution
103.587 In distribution
101.076 In distribution
108.046 In distribution
118.081 In distribution
103.464 Outer Diameter 4 mm In distribution
108.021 Outer Diameter 4.1 mm In distribution
108.126 Outer Diameter 5 mm In distribution
108.196 In distribution
118.342 In distribution
125.011 Outer Diameter 4.1 mm In distribution
125.110-ET In distribution
118.240 Outer Diameter 5 mm In distribution
118.087 In distribution
129034 Length 93.44 mm In distribution
103.576 Outer Diameter 6 mm In distribution
103.626 Outer Diameter 5.0 mm In distribution
103.494 Outer Diameter 3.75 mm In distribution
101.039 In distribution
108.187 In distribution
114.212 Height 6 mm In distribution
114.214 Height 6 mm In distribution
125.161 Outer Diameter 7 mm In distribution
130.070 Outer Diameter 0.9 mm In distribution
128.036 In distribution
114.789 Height 3.5 mm In distribution
114.796 Height 1.5 mm In distribution
108.174 Outer Diameter 4.5 mm In distribution
103.496 Outer Diameter 4.3 mm In distribution
105.169 Length 33 mm In distribution
103.495 Outer Diameter 4 mm In distribution
103524 Outer Diameter 2.7 mm In distribution
114.211 Outer Diameter 4.5 mm In distribution
103.596 In distribution
114.792 Height 6 mm In distribution
130.117 In distribution
125.181 Lumen/Inner Diameter 4.3 mm In distribution
108.092 In distribution
130.083 In distribution
101.100 In distribution
105.167 In distribution
103.483 Outer Diameter 3.75 mm In distribution
125176 Length 20.5 mm In distribution
103.497 Outer Diameter 5 mm In distribution
130.120 In distribution
125.186 Length 5.5 mm In distribution
125.108 In distribution
105.128 In distribution
101.020 In distribution
114.230 Height 0.8 mm In distribution
108.093 In distribution
108.138 Outer Diameter 5 mm In distribution
108.230 Height 2.5 mm In distribution
103584 Outer Diameter 5.1 mm In distribution
108.221 In distribution
114.798 Height 3.5 mm In distribution
103.477 Outer Diameter 3.75 mm In distribution
125.138 In distribution
108.142 In distribution
108.243 In distribution
108.124 Outer Diameter 3.3 mm In distribution
125.195 Outer Diameter 5.0 mm In distribution
123.002 In distribution
108.201 In distribution
125.129 Outer Diameter 5 mm In distribution
103.624 Outer Diameter 4.0 mm In distribution
103.039 Outer Diameter 3.3 mm In distribution
103.588 In distribution
101.099 In distribution
125.148 Height 8 mm In distribution
125.154 Outer Diameter 4 mm In distribution
125.191 Length 7.0 mm In distribution
103.750 In distribution
125.135 In distribution
101.061 In distribution
114.221 Height 3.5 mm In distribution
101.092-ET In distribution
104.070 In distribution
101.074 In distribution
104.012 Outer Diameter 1.2 mm In distribution
130.071 Outer Diameter 1.2 mm In distribution
103532 Outer Diameter 4 mm In distribution
125.216 In distribution
103.589 In distribution
129.037 Outer Diameter 2.35 mm In distribution
108.065 In distribution
118.298 In distribution
103.475 Outer Diameter 2 mm In distribution
130.020 Outer Diameter 2.5 mm In distribution
103.563 Outer Diameter 3.5 mm In distribution
118.299 Outer Diameter 4.8 mm In distribution
103.487 Outer Diameter 7 mm In distribution
118.334 In distribution
125.193 Outer Diameter 3.75 mm In distribution
116.272 In distribution
114.219 Outer Diameter 3.3 mm In distribution
128.038 In distribution
118.104 In distribution
108.068 Outer Diameter 4.1 mm In distribution
105.180 In distribution
105.068 In distribution
125.112 Outer Diameter 3.3 mm In distribution
130.017 Outer Diameter 1.6 mm In distribution
118.295 In distribution
108.022 Outer Diameter 4.1 mm In distribution
123.015 In distribution
118.253 Outer Diameter 5 mm In distribution
114.191 Height 4 mm In distribution
101.070 In distribution
103530 Outer Diameter 4 mm In distribution
118.331 In distribution
125.143-ET In distribution
108.072 In distribution
108.133 Outer Diameter 5 mm In distribution
114.780 Outer Diameter 4.5 mm In distribution
118.327 In distribution
108.075 Outer Diameter 4.1 mm In distribution
103.627 Outer Diameter 6.0 mm In distribution
125.204 Outer Diameter 7.0 mm In distribution
105.089 Outer Diameter 3.5 mm In distribution
116.063 Outer Diameter 4.1 mm In distribution
108.139 In distribution
103535 Outer Diameter 4 mm In distribution
108.220 In distribution
114.782 Height 4.5 mm In distribution
104.074 Outer Diameter 7.9 mm In distribution
108.147 In distribution
103.463 Outer Diameter 3.75 mm In distribution
101.098 In distribution
103.574 Outer Diameter 5 mm In distribution
114.336 Outer Diameter 2.5 mm In distribution
103.092 In distribution
114.785 Height 6 mm In distribution
103539 Outer Diameter 4.3 mm In distribution
125.196 Outer Diameter 6.0 mm In distribution
108.222 In distribution
125.126 Outer Diameter 3.5 mm In distribution
125.023 In distribution
130.018 Outer Diameter 1.8 mm In distribution
108.103 In distribution
130.098 In distribution
118.248 In distribution
105.171 Length 33 mm In distribution
108.043 Length 6 mm In distribution
108.002 Outer Diameter 3.3 mm In distribution
108.095 In distribution
128.033 In distribution
108.204 In distribution
101.110 Outer Diameter 5.5 mm In distribution
111.035 In distribution
105.050 Outer Diameter 5 mm In distribution
108.010 In distribution
108.145 Outer Diameter 4.5 mm In distribution
125.131 In distribution
114.217 Outer Diameter 4.5 mm In distribution
105.017 In distribution
108.180 Outer Diameter 3.5 mm In distribution
101.086-ET In distribution
108.047 In distribution
118.254 In distribution
101.105 In distribution
125.103 In distribution
101.088-ET In distribution
114.776 Outer Diameter 3.3 mm In distribution
125.189 Length 4.0 mm In distribution
101.080-ET In distribution
104.042 In distribution
114.216 Height 4.5 mm In distribution
103.031 Outer Diameter 5 mm In distribution
108.233 Height 5.5 mm In distribution
103.512 Outer Diameter 5 mm In distribution
108.244 In distribution
103.129 Outer Diameter 4.1 mm In distribution
105.160 In distribution
108.247 In distribution
101.004 In distribution
125.121 Outer Diameter 3.5 mm In distribution
114.199 Outer Diameter 3.3 mm In distribution
125.113 Outer Diameter 2 mm In distribution
125.187 Lumen/Inner Diameter 5.2 mm In distribution
108.023 Outer Diameter 5 mm In distribution
114.794 Outer Diameter 4.5 mm In distribution
114.793 Height 6 mm In distribution
108.186 In distribution
108.064 In distribution
125.144 Outer Diameter 2 mm In distribution
103.430 In distribution
108.188 In distribution
105.150 In distribution
125.095 Outer Diameter 4.3 mm In distribution
108.070 In distribution
125.101 In distribution
108.159 In distribution
103.505 Outer Diameter 3.5 mm In distribution
105.088 Outer Diameter 3.5 mm In distribution
101.107 In distribution
125.185 Lumen/Inner Diameter 5.2 mm In distribution
108.175 Length 6 mm In distribution
125.102 In distribution
108.141 In distribution
103.568 Outer Diameter 4 mm In distribution
118.323 In distribution
125.201 Outer Diameter 4.3 mm In distribution

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
Nobel Biocare® Nobel Biocare AB 703
MIS MIS Implants Technologies Ltd. 615
Astra Tech Implant System® Dentsply Implants Manufacturing GmbH 596

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