Manufacturer registered with FDA
Smart Denture Conversions, LLC
Apex, NC, United States. Lists 7 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 7
- Brands and models
- 2
- 510(k) clearances
- 22025–2026
- Markets registered in
- 211 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name Smart Denture Conversions, LLC as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Smart Denture Conversions, LLC | 2 clearances | 2025–2026 | Below |
| Australia | TGA | Manufacturer | Smart Denture Conversions LLC | 11 | 2025–2026 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Smart Denture Conversions, LLC 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 AbutmentNHA · Class 2 | Implant abutments | Maker | Prosthetic Screw, Paltop (IHex) | 2024 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Lister | Prosthetic Screw, Paltop (IHex) | 2024 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | — | 2024 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | — | 2024 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | — | 2024 |
| Preformed AnchorEJX · Class 1 | — | Maker | — | 2019 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | — | 2019 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Smart Denture Conversions, LLC as the applicant.
Also lists devices cleared under other names
Smart Denture Conversions, LLC 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: BioHorizons Implant Systems, Inc. (1), Keystone Dental Inc. (1), Young Innovations Inc (1), Bioloren S.R.L. (1), Terrats Medical, S.L. (1), Paltop Advanced Dental Solutions Inc. (1), Biomet 3i, LLC (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 13 Oct 2023 | K223697 | MRI compatibility for existing BioHorizons dental implants and abutments | BioHorizons Implant Systems, Inc. | DZE Root-Form Endosseous Implant |
| 10 Aug 2022 | K221381 | KDG Abutments | Keystone Dental Inc. | NHA Endosseous Dental Implant Abutment |
| 18 Mar 2019 | K183518 | Preat Abutments | Young Innovations Inc | NHA Endosseous Dental Implant Abutment |
| 24 Feb 2018 | K173643 | Trilor Disks, Blocks and Arches | Bioloren S.R.L. | EBF Resin Tooth Shade Material |
| 8 Aug 2017 | K170588 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 20 Apr 2012 | K112795 | PALTOP DENTAL IMPLANT SYSTEM | Paltop Advanced Dental Solutions Inc. | DZE Root-Form Endosseous Implant |
| 30 Nov 2009 | K092341 | LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION | Biomet 3i, LLC | NHA Endosseous Dental Implant Abutment |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SMART DENTURE CONVERSIONS, LLCFDA reg. 3015527825 | Apex, NC, United States | Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10060412). 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.