Manufacturer registered with FDA
Digital Age Dental Laboratories, Ltd.
Palm Beach Gardens, FL, United States. Lists 6 dental device types with FDA across 1 registered establishment.
- Device types listed
- 6
- Brands and models
- 38
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Vietnam
Devices listed with FDA
What Digital Age Dental Laboratories, Ltd. 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 | Biodenta Customized Abutment - TitaniumBiodenta Customized Abutment-HybridBioHorizons Tapered Internal Implant System (includes 3-in-1 abutments)BioHorizons Tapered Pro Conical Implant System (Conical Esthetic Abutments, 0°, 2 mm GH, Narrow platform)CONELOG Esthomic AbutmentsCONELOG Inset AbutmentsCONELOG Titanium Base CAD/CAMDentis Implant System (including abutments)DESS Ti Base AbutmentsHiossen EK Angled Abutments 13 moreHiossen Mini ET Transfer AbutmentsImplant Direct InterActive AbutmentsImplant Direct Legacy AbutmentsLOCATOR Abutments (Zest Anchors)MegaGen EZ Post AbutmentsNeodent GM Titanium Base AbutmentsNobel Esthetic AbutmentsPreat AbutmentsStraumann BLX/Anatomic AbutmentsStraumann Cementable AbutmentsStraumann Variobase AbutmentsZimmer Contour AbutmentsZimmer Hex-Lock Abutments | 2017 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | BioHorizons Tapered Internal Implant System (includes 3-in-1 abutments)BioHorizons Tapered Pro Conical Implant System (Conical Esthetic Abutments, 0°, 2 mm GH, Narrow platform)Biomet 3i Cast-To Gold Abutments (NP Engaging 3.5 mm 2.9 mm)CONELOG Inset AbutmentsHiossen EK Angled AbutmentsImplant Direct InterActive AbutmentsNeodent GM Anatomic AbutmentsNeodent GM Titanium Base AbutmentsSterngold ERA AbutmentsStraumann BLX/Anatomic Abutments 1 moreStraumann ITI Prosthetic Abutments | 2025 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | N/A | 2013 |
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | Straumann Variobase Abutments | 2025 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Maker | Post and Core | 2025 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Lister | 3 Shape Lab Scanner | 2024 |
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
Digital Age Dental Laboratories, Ltd. 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: Institut Straumann AG (6), CAMLOG Biotechnologies GmbH (3), BioHorizons Implant Systems, Inc. (2), Hiossen Inc. (2), Biodenta Swiss AG (2), Implant Direct (2), Zimmer Dental, Inc. (2), Megagen Implant Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 5 Jun 2024 | K240187 | Tapered Pro Conical Implant System | BioHorizons Implant Systems, Inc. | DZE Root-Form Endosseous Implant |
| 22 Jan 2024 | K233450 | MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown Screw | Megagen Implant Co., Ltd. | NHA Endosseous Dental Implant Abutment |
| 15 May 2023 | K222836 | Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs | Institut Straumann AG | NHA Endosseous Dental Implant Abutment |
| 28 Apr 2023 | K222636 | ET Abutment System | Hiossen Inc. | NHA Endosseous Dental Implant Abutment |
| 11 Mar 2022 | K212628 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 11 Jan 2022 | K213391 | High Retention Attachment System | Zest Anchors, LLC | NHA Endosseous Dental Implant Abutment |
| 7 Jan 2022 | K203360 | EK Implants and Abutments System | Hiossen Inc. | DZE Root-Form Endosseous Implant |
| 15 Mar 2021 | K203382 | Neodent Implant System-Easy Pack | Institut Straumann AG | DZE Root-Form Endosseous Implant |
| 12 Feb 2021 | K203355 | Straumann TLX Novaloc and Cementable Abutments | Institut Straumann AG | NHA Endosseous Dental Implant Abutment |
| 4 Sep 2020 | K201225 | Neodent Implant System - GM Helix Implants 7.0 | Institut Straumann AG | DZE Root-Form Endosseous Implant |
| 28 Dec 2018 | K181703 | Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments | Institut Straumann AG | DZE Root-Form Endosseous Implant |
| 29 Nov 2017 | K171694 | s-Clean TiN Coating Abutments | Dentis Co., Ltd. | NHA Endosseous Dental Implant Abutment |
| 12 Jan 2016 | K152509 | CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR) | CAMLOG Biotechnologies GmbH | 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 |
| 17 Feb 2015 | K143337 | CONELOG Titanium base CAD/CAM | CAMLOG Biotechnologies GmbH | NHA Endosseous Dental Implant Abutment |
| 24 Dec 2013 | K130572 | INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM | Implant Direct | DZE Root-Form Endosseous Implant |
| 14 Dec 2012 | K113779 | CONELOG IMPLANT SYSTEM | CAMLOG Biotechnologies GmbH | DZE Root-Form Endosseous Implant |
| 23 Jun 2011 | K111581 | 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 1.5MM, 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 3MM, 15 ESTHETIC ABUTMENT NOBELACTIVE | Nobel Biocare Services AG | NHA Endosseous Dental Implant Abutment |
| 7 Apr 2009 | K090723 | HEX-LOCK SHORT ABUTMENT, MODEL SA341, SA342, SA451, SA452, SA561, SA562 SHORT HEALING CAP, MODEL SAHEAL4, SAHEAL5, | Zimmer Dental, Inc. | NHA Endosseous Dental Implant Abutment |
| 10 Oct 2007 | K071638 | BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM | BioHorizons Implant Systems, Inc. | DZE Root-Form Endosseous Implant |
| 27 Jun 2006 | K061043 | ZIMMER CONTOUR RESTORATIVE SYSTEM | Zimmer Dental, Inc. | NHA Endosseous Dental Implant Abutment |
| 19 May 2006 | K060063 | LEGACY ABUTMENT SYSTEM | Implant Direct | NHA Endosseous Dental Implant Abutment |
| 26 Jun 2002 | K021045 | ERA IMPLANT | Sterngold | DZE Root-Form Endosseous Implant |
| 19 Dec 2001 | K013798 | PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM | Institut Straumann AG | DZE Root-Form Endosseous Implant |
| 19 Nov 2001 | K013227 | SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANT | Sulzer Dental, Inc. | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Digital Age Dental Laboratories, Ltd.FDA reg. 3007597023 | Vinh Tan Ward Ho Chi Minh, Vietnam | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10028093). 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.