Axiom®

Guided Drill Ø2.4/3.0 L12 G4.2

Registry build 21.09.26
70manufacturers in China registered for this device type
395catalogue 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 Axiom®
Listed by Etablissements Anthogyr
FDA product code NDP
Device type Accessories, Implant, Dental, Endosseous
Device class Class 1
Regulation 21 CFR 872.3980
Premarket notification Exempt
Record published 2024-01-10
Record revised 2024-11-07 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Single use Yes
Prescription Prescription only
Label carries lot or batch number, manufacturing date, serial number
Sizes Outer diameter 0.75 to 37 mm; length 4.2 to 42.5 mm; angle 7 to 23 °
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Axiom®
Catalogue number Size Status
OPSA504 Outer Diameter 5.0 mm In distribution
OPFPSL20-ET Outer Diameter 2 mm In distribution
OPCA304 Outer Diameter 3.4 mm In distribution
OPFI20S Outer Diameter 2.0 mm In distribution
GTA46G50S Length 31.8 mm In distribution
INEXPL In distribution
GFE30L8G42 Outer Diameter 5 mm In distribution
INMHEXLV In distribution
MUT100-4 PLATFORM R/4.8 mm In distribution
OPB4208C Outer Diameter 4.2 mm In distribution
GPDG36S Outer Diameter 3.6 mm In distribution
GFE30L12G42 Outer Diameter 5 mm In distribution
INGPPA In distribution
GTP46G50S Outer Diameter 24 mm In distribution
OPSA406 Coronal
height 6 mm
In distribution
OPAF011 Gingival height 1.5mm In distribution
GTIWG50S Outer Diameter 8 mm In distribution
OPGPDMXL Extra-long In distribution
GCBG36S Outer Diameter 3.6 mm In distribution
GTIWG42S Length 21.2 mm In distribution
GFI20L4G42 Outer Diameter 5 mm In distribution
GTIMG42S Outer Diameter 4 mm In distribution
OPSA506 Outer Diameter 5.0 mm In distribution
OPB3016L Length 16 mm In distribution
OPFF66 Outer Diameter 6.6 mm In distribution
GFI20L8G36 Length 32.200000000000003 mm In distribution
OPROFIL420 Outer Diameter 4 mm In distribution
OPROFIL510 Outer Diameter 5 mm In distribution
OPB3608C Length 8 mm In distribution
OPPI100-4 Long In distribution
OPB5410C Outer Diameter 5.4 mm In distribution
GTP34G36S Length 24 mm In distribution
OPAF001 Angle 15 ° In distribution
INCHELV In distribution
OPAF041 Angle 15 ° In distribution
OPGS20-10 Outer Diameter 2 mm In distribution
OPB6008C Outer Diameter 6.0 mm In distribution
GFE42L6G50 Outer Diameter 5.8 mm In distribution
OPCV110 In distribution
OPFE24S Ø2.0/2.4 S In distribution
OPCS100 In distribution
GMVG36L Outer Diameter 3.4 mm In distribution
OPFPSL20-3 Outer Diameter 2 mm In distribution
INPIL In distribution
GMVG36S Outer Diameter 3.4 mm In distribution
OPB4806L Length 6 mm In distribution
OPPI100 In distribution
OPROFIL530 Outer Diameter 5 mm In distribution
152-27-SAA In distribution
152-27-PA-4 In distribution
GFE42L14G50 Length 38 mm In distribution
OPAF042 Angle 23 ° In distribution
OPB3614L Length 14 mm In distribution
OPSF036 Gingival height 3.5mm In distribution
GFE36L6G42 Length 30.9 mm In distribution
INKITSSBL In distribution
PXFE32S Ø3.0/3.2 S In distribution
OPFE42S Ø3.6/4.2 S In distribution
OPB4210L Outer Diameter 4.2 mm In distribution
OPSF006 Gingival height 0.75mm In distribution
GCVG50S Outer Diameter 8 mm In distribution
OPB6010C Length 10 mm In distribution
OPB4214L Length 14 mm In distribution
GMVG50L Outer Diameter 4.8 mm In distribution
OPGS20 Outer Diameter 2 mm In distribution
OPFF53 Outer Diameter 5.3 mm In distribution
PROSTHSET-WS S In distribution
OPGS36-ET In distribution
OPB3006C Outer Diameter 3.0 mm In distribution
INBM100XL XL In distribution
OPGS36 Outer Diameter 5.8 mm In distribution
OPR8 Outer Diameter 8 mm In distribution
GCBG50L Length 5 mm In distribution
OPGS50-4 Outer Diameter 7.2 mm In distribution
MUA100 PLATFORM R/4.8 mm In distribution
MUNT200-4 PLATFORM N/4.0 mm In distribution
GBAG36S Length 23.5 mm In distribution
OPFE30S Ø2.4/3.0 S In distribution
GFI20L8G50 Outer Diameter 5.8 mm In distribution
OPB3018L Length 18 mm In distribution
GTIWG42L Outer Diameter 8 mm In distribution
GTIMG50S Short In distribution
GFE36L6G50 Outer Diameter 5.8 mm In distribution
OPB3610C Length 10 mm In distribution
GFI20L6G50 Length 30.7 mm In distribution
OPJD048 Outer Diameter 4.8 mm In distribution
151-04-DT-MUN In distribution
GTA34G50L Outer Diameter 4.8 mm In distribution
OPCR306 Outer Diameter 3.4 mm In distribution
INBM100L LONG In distribution
INEXPS In distribution
GFE30L6G50 Outer Diameter 5.8 mm In distribution
GFE30L14G42 Outer Diameter 5 mm In distribution
MUNFLEXC Outer Diameter 4.0 mm In distribution
GFE36L8G50 Length 32.4 mm In distribution
OPAF012 Angle 23 ° In distribution
GFE36L14G50 Outer Diameter 5.8 mm In distribution
OPPO15150 Outer Diameter 1.5 mm In distribution
OPB4808L Length 8 mm In distribution
OPFPSL20-5 Outer Diameter 2 mm In distribution
INCCDC In distribution
OPTA40L Outer Diameter 4.0 mm In distribution
GCBG36L Outer Diameter 3.6 mm In distribution
OPR20 In distribution
AATOOL In distribution
GFE24L12G42 Length 36 mm In distribution
OPB3612L Length 12 mm In distribution
OPFI20L Outer Diameter 2.0 mm In distribution
OPB3610L Length 10 mm In distribution
OPAF00-7 Gingival height 0.75mm In distribution
MUT102 In distribution
GBAG50S Outer Diameter 5.8 mm In distribution
OPMU161 In distribution
OPB3010C Outer Diameter 3.0 mm In distribution
OPSF026 Gingival height 2.5mm In distribution
GFI20L14G42 Length 38.200000000000003 mm In distribution
GTIMG42L Outer Diameter 4 mm In distribution
OPCR406 Outer Diameter 4.0 mm In distribution
GFI20L12G36 Length 36.200000000000003 mm In distribution
OPAF032 Gingival height 3.5mm In distribution
INBW100S Short In distribution
OPPI100S-4 In distribution
GTA34G36S Length 31.8 mm In distribution
OPJD024 Outer Diameter 2.4 mm In distribution
OPPU100 In distribution
OPGS36-10 Length 4.5 mm In distribution
GFE24L10G42 Outer Diameter 5 mm In distribution
GFE30L14G36 Length 38.200000000000003 mm In distribution
INSETIGM In distribution
GMVG50S Length 30.7 mm In distribution
GFI20L8G42 Outer Diameter 5 mm In distribution
OPCA306 Outer Diameter 3.4 mm In distribution
GFE36L14G42 Outer Diameter 5 mm In distribution
SATOOL-01 In distribution
INGFA In distribution
GFE24L8G36 Length 32 mm In distribution
PXFE44S Ø4.2/4.4 S In distribution
OPIA100-4 In distribution
GFE36L10G50 Outer Diameter 5.8 mm In distribution
INCHEXLV In distribution
MUNT200 PLATFORM N/4.0 mm In distribution
151-04-SAO In distribution
OPROFIL520 Outer Diameter 5 mm In distribution
GFI20L12G42 Length 36.200000000000003 mm In distribution
GFE30L6G36 Length 30.7 mm In distribution
INMHELV In distribution
OPSA306 Coronal
height 6 mm
In distribution
OPB3608L Outer Diameter 3.6 mm In distribution
OPROFIL430 Outer Diameter 4 mm In distribution
OPFF-3 In distribution
OPFF45 Outer Diameter 4.5 mm In distribution
MU141 In distribution
OPAF031 Gingival height 3.5mm In distribution
INKITSCWBL In distribution
OPFE36S Ø3.0/3.6 S In distribution
GTP40G50S Outer Diameter 24 mm In distribution
GPDG42S Outer Diameter 31.5 mm In distribution
MUA100-4 PLATFORM R/4.8 mm In distribution
OPIA100 In distribution
GFE24L10G50 Outer Diameter 5.8 mm In distribution
OPSA604 Coronal
height 4 mm
In distribution
GFE36L12G42 Length 36.4 mm In distribution
OPB4208L Outer Diameter 4.2 mm In distribution
MUNT100-4 PLATFORM N/4.0 mm In distribution
GFE24L14G50 Length 38 mm In distribution
GTIMG50L Long In distribution
OPCR404 Coronal
height 4 mm
In distribution
OPTA34L Outer Diameter 3.4 mm In distribution
OPPU100L-4 In distribution
GFE30L10G36 Length 34.200000000000003 mm In distribution
INFB20 Outer Diameter 2 mm In distribution
GPDG50S Length 5 mm In distribution
MUM100 In distribution
OPCR304 Coronal
height 4 mm
In distribution
GTA40G50S Outer Diameter 4.8 mm In distribution
GFE24L6G50 Length 30.5 mm In distribution
151-03-PA In distribution
OPB3606L Outer Diameter 3.6 mm In distribution
GFE30L14G50 Length 38.200000000000003 mm In distribution
OPB3012L Outer Diameter 3.0 mm In distribution
OPAF021 Angle 15 ° In distribution
OPCV060 In distribution
MUT101 In distribution
GFI20L10G42 Length 34.200000000000003 mm In distribution
OPGS42-10 Outer Diameter 6.4 mm In distribution
OPROFIL410 Outer Diameter 4 mm In distribution
GFE30L12G36 Length 36.200000000000003 mm In distribution
OPCA404 Outer Diameter 4.0 mm In distribution
OPPU102 In distribution
GFE24L6G36 Length 30.5 mm In distribution
OPCR504 Outer Diameter 5.0 mm In distribution
OPB4210C Length 10 mm In distribution
MUA200-4 PLATFORM R/4.8 mm In distribution
152-27-PA In distribution
MUT200 PLATFORM R/4.8 mm In distribution
PXFE38S Ø3.6/3.8 S In distribution
MUNA100 PLATFORM N/4.0 mm In distribution
MUNA200 PLATFORM N/4.0 mm In distribution
GFI20L14G36 Length 38.200000000000003 mm In distribution
OPAF02-7 Gingival height 2.5mm In distribution
OPTA-4 In distribution
GCBG42L Outer Diameter 33.5 mm In distribution
MUNA100-4 PLATFORM N/4.0 mm In distribution
OPGS50 Outer Diameter 7.2 mm In distribution
INPIM In distribution
GFI20L4G50 Length 28.2 mm In distribution
OPGS42-4 Length 4.5 mm In distribution
OPGDM-20XL Extra-long In distribution
GFI20L10G36 Length 34.200000000000003 mm In distribution
OPAF03-7 Gingival height 3.5mm In distribution
GFI20L6G36 Length 30.7 mm In distribution
OPB3008L Length 8 mm In distribution
PROSTHSET-MS S In distribution
OPSF046 Gingival height 4.5mm In distribution
OPB4810L Length 10 mm In distribution
GBAG42S Outer Diameter 5 mm In distribution
OPB3014L Outer Diameter 3.0 mm In distribution
151-03-PA-4 In distribution
MUWS In distribution
GCBG42S Outer Diameter 29.5 mm In distribution
INMHECV In distribution
OPJC001 In distribution
OPSF016 Gingival height 1.5mm In distribution
INCHECV In distribution
MUFLEXC Outer Diameter 4.8 mm In distribution
INMD075 In distribution
GFE42L10G50 Outer Diameter 5.8 mm In distribution
OPB4212L Length 12 mm In distribution
INBM100S SHORT In distribution
INCM In distribution
OPGU180 Outer Diameter 1.8 mm In distribution
OPFI15L Outer Diameter 1.5 mm In distribution
PA-TOOL-01CAP In distribution
OPFE54S Ø4.8/5.4 S In distribution
OPAF01-7 Gingival height 1.5mm In distribution
OPCR604 Coronal
height 4 mm
In distribution
OPJD054 Outer Diameter 5.4 mm In distribution
MUAA142-4 In distribution
OPPU100L In distribution
PXFC_NOT In distribution
OPGS50-10 Length 4.5 mm In distribution
OPAF002 Angle 23 ° In distribution
OPGS36-4 Length 4.5 mm In distribution
MUA200 PLATFORM R/4.8 mm In distribution
INMDS In distribution
OPMV215 In distribution
PROSTHSET-WL L In distribution
GFE36L12G50 Outer Diameter 5.8 mm In distribution
OPMV180 SHORT MANDREL In distribution
OPPU101 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
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