Neodent

Self-Drilling Graft Screw (Wide)

Registry build 21.09.26
3manufacturers in China registered for this device type
24catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (1), Shanghai (1), Fujian (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DZL
Manufacturer City Province Registered as Device types
Changzhou Biomet Medical Devices Co., Ltd. Changzhou Jiangsu Contract manufacturer 54
LX Precision Shanghai Co Ltd Shanghai Shanghai Contract manufacturer 19
Dentalmaster (Xiamen) Medical Technology Co., Ltd. Xiamen Fujian Manufacturer 1

Record

Regulatory record for Neodent
Listed by Jjgc Indústria e Comércio de Materiais Dentários S.A., Brazil
FDA product code DZL
Device type Screw, Fixation, Intraosseous
Device class Class 2
Regulation 21 CFR 872.4880
Record published 2015-09-22
Record revised 2024-06-19 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
Storage Special storage condition: Protect from sunlight.
Sizes Length 4 to 14 mm; outer diameter 1.5 to 2 mm

Catalogue Numbers

Catalogue numbers for Neodent
Catalogue number Size Status
116.206 Length 9 mm In distribution
116.196 Length 8 mm In distribution
116.198 Length 10 mm In distribution
116.216 Length 12 mm In distribution
116.208 Outer Diameter 2 mm In distribution
116.215 Length 10 mm In distribution
116.207 Outer Diameter 2 mm In distribution
116.210 Outer Diameter 1.5 mm In distribution
116.195 Outer Diameter 1.5 mm In distribution
116.205 Outer Diameter 2 mm In distribution
116.214 Outer Diameter 2 mm In distribution
116.212 Outer Diameter 1.5 mm In distribution
116.194 Outer Diameter 1.5 mm In distribution
116.213 Length 14 mm In distribution
116.193 Outer Diameter 1.5 mm In distribution
116.204 Outer Diameter 2 mm In distribution
116.199 Length 12 mm In distribution
116.197 Outer Diameter 1.5 mm In distribution
116.203 Length 6 mm In distribution
116.201 Length 4 mm In distribution
116.202 Outer Diameter 2 mm In distribution
116.200 Length 14 mm In distribution
116.209 Length 12 mm In distribution
116.211 Length 10 mm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
OsteoMed Osteomed 1,295
Faico CMF System Faico Medical, LLC 540
Neoface Neoortho Produtos Ortopédicos S/A 181
CMF Visionare Visionare LLC 155
Universal Mandible AXS Stryker Leibinger Gmbh & Co. KG 148
Tandry CMF Plate System Microware Precision Co., Ltd. 140
Screw, Fixation, Intraosseous Synthes Gmbh 132
Level ONE CMF KLS-Martin L.P. 71
MatrixMIDFACE Synthes Gmbh 65
PlusDrive Synthes Gmbh 52
Universal 2.0 MP AXS Stryker Leibinger Gmbh & Co. KG 51
MCI – Medical Concept Innovation, Inc. MCI Medical Concept Innovation Inc. 49

Showing 12 of 92. All products under Screw, Fixation, Intraosseous

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