Registered with FDA
BioAbutment Inc.
Irvine, CA, United States. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 6
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What BioAbutment Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Lister | Digital AnalogLab AnalogScan BodyScan Body KitScrew Driver | 2025 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Lister | ALLONUS Tech Prosthetics | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
BioAbutment Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: ALLONUS Tech Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 17 Dec 2024 | K241616 | ALLONUS Tech Prosthetics | ALLONUS Tech Co., Ltd. | NHA Endosseous Dental Implant Abutment |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| BIOABUTMENT INC.FDA reg. 3035532394 | Irvine, CA, United States | Complaint file establishment |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10092695). 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.