Manufacturer registered with FDA
National Dentex LLC
Palm Beach Gardens, FL, United States. Lists 8 dental device types with FDA across 9 registered establishments, and holds 1 510(k) clearance as applicant.
- Device types listed
- 8
- Brands and models
- 16
- 510(k) clearances
- 12012–2012
- Markets registered in
- 1United States
- Establishments
- 9United States
510(k) clearances per year, 2007–2026
Devices listed with FDA
What National Dentex 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 | Lister | Biotenta Customized Abutment - HybridBiotenta Customized Abutment - TitaniumDESS Ti Base AbutmentsPreat Abutments | 2017 |
| Anti-Snoring DeviceLRK · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | ClearDreamElastic Mandibular Advancement (EMA) ApplianceEMASomnoDent MASTAP Anti-snoring DeviceTAP Thornton Adjustable Positioner | 2008 |
| Dental Abutment Design Software for Dental LaboratoryPNP · Class 2 | Dental design & orthodontic software | Lister | DESS Ti Base Abutments | 2026 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Surgical Guide | 2019 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Lister | Preat Abutments | 2023 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | SomnoDent MAS | 2008 |
| Preformed CrownELZ · Class 1 | — | Lister | Preformed Crown | 2011 |
| Jaw Repositioning DeviceLQZ · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | PM Positioner | 2008 |
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
National Dentex 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: Terrats Medical, S.L. (11), Young Innovations Inc (2), Biodenta Swiss AG (2), Institute For Quality Resource Management (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 5 Nov 2024 | K242340 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 26 Aug 2024 | K240982 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 24 Apr 2024 | K240208 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 9 Mar 2023 | K221301 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 27 Oct 2022 | K222288 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 26 Oct 2022 | K220823 | Preat Abutments | Young Innovations Inc | NHA Endosseous Dental Implant Abutment |
| 11 Mar 2022 | K212628 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 10 Dec 2021 | K212577 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 4 Aug 2021 | K203464 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 10 Nov 2019 | K191986 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 18 Mar 2019 | K183518 | Preat Abutments | Young Innovations Inc | NHA Endosseous Dental Implant Abutment |
| 15 Jun 2018 | K173908 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 8 Aug 2017 | K170588 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 1 Dec 2015 | K151295 | Biodenta Customized Abutment - Titanium | Biodenta Swiss AG | NHA Endosseous Dental Implant Abutment |
| 2 Jul 2015 | K150296 | Biodenta Customized Abutment-Hybrid | Biodenta Swiss AG | NHA Endosseous Dental Implant Abutment |
| 16 Oct 2014 | K133390 | NDX DORSAL APPLIANCE | Institute For Quality Resource Management | LRK Anti-Snoring Device |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ALBENSI DENTAL LABFDA reg. 3004755100 | Irwin, PA, United States | Manufacturer |
| DAVIS DENTAL LABFDA reg. 3004935484 | Wyoming, MI, United States | Contract manufacturer, Manufacturer |
| GREEN DENTAL LABFDA reg. 3002916277 | Heber Springs, AR, United States | Contract manufacturer, Manufacturer |
| Group Practice SolutionsFDA reg. 3006473685 | Sarasota, FL, United States | Repacker / relabeler |
| KELLER LABORATORIESFDA reg. 3006650414 | Fenton, MO, United States | Contract manufacturer, Manufacturer |
| NDX nSequenceFDA reg. 3010138699 | Reno, NV, United States | Manufacturer |
| NDX Paramount Dental LaboratoryFDA reg. 3012690648 | Sacramento, CA, United States | Repacker / relabeler |
| NELSON DENTAL LABFDA reg. 3005512166 | Rochester Hills, MI, United States | Repacker / relabeler |
| TRIDENT LAB INC.FDA reg. 2087481 | HAWTHORNE, CA, United States | Repacker / relabeler |
Other names on FDA records
NDX Paramount Dental Laboratory · Nelson Dental Lab · Group Practice Solutions · Davis Dental Lab · Trident Lab Inc. · Keller Laboratories · Green Dental Lab · Albensi Dental Lab · NDX nSequence
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9052467, 9054557, 10040830). 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.