8dent Inc.
US Last updated 30 May 2026 Part of 8dent Inc.
- Devices
- 35
- Registries
- GUDIDFDA
- FDA recalls
- 0
Catalogue
8plant Implant System BM3508 Ref BM3508
8plant Implant System BR4007 Ref BR4007
8plant Implant System BM3510 Ref BM3510
8plant Implant System BM3511 Ref BM3511
8plant Implant System BR4008 Ref BR4008
8plant Implant System BR4010 Ref BR4010
8plant Implant System BM3513 Ref BM3513
8plant Implant System BR4011 Ref BR4011
8plant Implant System BR4013 Ref BR4013
8plant Implant System BR4507 Ref BR4507
8plant Implant System BR4508 Ref BR4508
8plant Implant System BR4510 Ref BR4510
8plant Implant System BR4511 Ref BR4511
8plant Implant System BR4513 Ref BR4513
8plant Implant System BR5007 Ref BR5007
8plant Implant System BR5008 Ref BR5008
8plant Implant System BR5010 Ref BR5010
8plant Implant System BR5011 Ref BR5011
8plant Implant System BR5013 Ref BR5013
8plant Implant System BR5507 Ref BR5507
8plant Implant System BR5508 Ref BR5508
8plant Implant System BR5510 Ref BR5510
8plant Implant System BR5511 Ref BR5511
8plant Implant System BR5513 Ref BR5513
8plant Implant System BW6007 Ref BW6007
8plant Implant System BW6008 Ref BW6008
8plant Implant System BW6010 Ref BW6010
8plant Implant System BW6011 Ref BW6011
8plant Implant System BW6013 Ref BW6013
8plant Implant System BW7007 Ref BW7007
8plant Implant System BW7008 Ref BW7008
8plant Implant System BW7010 Ref BW7010
8plant Implant System BW7011 Ref BW7011
8plant Implant System BW7013 Ref BW7013
Add-on Implant System ASM3508N Ref ASM3508N
FDA establishments
- 8dent Inc. Gimhae-si Gyeongnam · KR FEI 3033519161
What 8dent Inc. makes
8dent Inc. manufactures two-piece screw endosteal dental implants, including the 8plant system, designed for dental restoration procedures. These implants are intended for osseointegration within the jawbone to support dental prosthetics.
The company’s products are classified as Class II medical devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States.
Frequently asked questions
What types of medical devices does 8dent Inc. manufacture?
8dent Inc. specializes in screw endosteal dental implants, specifically two-piece systems. These devices are designed for dental restoration, enabling osseointegration within the jawbone to support dental prosthetics. The most common product category is the screw endosteal dental implant, such as the 8plant system.
Where is 8dent Inc. based?
8dent Inc. is based in the United States. The company’s headquarters and operations are located within the country, though specific regional offices or manufacturing sites are not detailed in the available information.
Which regulatory registries or databases list 8dent Inc.’s devices?
8dent Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices authorized for use in the United States, ensuring traceability and compliance with regulatory requirements.
How are 8dent Inc.’s devices classified under medical device regulations?
8dent Inc.’s devices, including screw endosteal dental implants like the 8plant system, are classified as Class II medical devices under FDA regulations. This classification is based on the level of risk associated with the device, where Class II devices require special controls in addition to general controls to ensure their safety and effectiveness.
Information
- Country
- US
- Website
- 8dent.co.kr
- [email protected]
- Phone
- +82517147240
- DUNS number
- 694477724