Manufacturer registered with FDA
Dentauspex Corporation
Douliu City, Taiwan. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 14
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Taiwan
Devices listed with FDA
What Dentauspex Corporation currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Biodenta Dental Implant SystemBiodenta Dental Implant System (Bone Level)BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3 TO 6 MMBIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL TAPEREDImplant, Endosseous, Root-Form - Biodenta Dental Implant System - Bone Level Tapered D 3 and L 6.5 mm | 2010 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Biodenta Customized Abutment - HybridBiodenta Customized Abutment - TitaniumBIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTSBIODENTA DENTAL IMPLANT SYSTEM - MULTI-USE ABUTMENTBIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3 TO 6 MM | 2013 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Biodenta / DentaSwiss ScanbodyBiodenta Dental Implant System - Surgical and Prosthetic AccessoryBioGuide / Guide SleeveMUA Sleeve | 2016 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Dentauspex CorporationFDA reg. 3017833095 | Douliu Yunlin, Taiwan | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10034185). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.