Skip to the page
Get started free

Data / Medical devices / Vietnam / Digital Age Dental Laboratories, Ltd.

Digital Age Dental Laboratories, Ltd.: FDA-registered device maker in Vinh Tan Ward Ho Chi Minh, Vietnam, 27 510(k) clearances

Digital Age Dental Laboratories, Ltd. is registered with the FDA (registration 3007597023) in Vinh Tan Ward Ho Chi Minh, Vietnam. It lists 13 device types. The FDA files 27 510(k) clearances under its listings, the newest dated June 5, 2024. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Digital Age Dental Laboratories, Ltd.
FDA registration number
3007597023
Address
No.19C, 27th Street, VSIP II-A, Vinh Tan Ward Ho Chi Minh, Vietnam, 70000
Owner or operator
Digital Age Dental Laboratories, Ltd. (10028093)
Roles
Contract manufacturer, Exporter to the US, Manufacturer
First device listed
December 29, 2008
Registered through
2027
Brand names listed
3 Shape Lab Scanner, Ankylos/X Esthetic Abutments, 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), Biodenta Customized Abutment - Titanium, Biodenta Customized Abutment-Hybrid, Biomet 3i Cast-To Gold Abutments (NP Engaging 3.5 mm 2.9 mm), CONELOG Esthomic Abutments and more

Devices it lists

DeviceProduct codeClassRoleSource
Abutment, Implant, Dental, EndosseousNHA2Contract manufacturer, Manufactureraccessdata.fda.gov
Dentures, FullNSLNExporter to the US, Manufactureraccessdata.fda.gov
Dentures, PartialNSKNExporter to the US, Manufactureraccessdata.fda.gov
Implant, Endosseous, Root-FormDZE2Manufactureraccessdata.fda.gov
Post, Root CanalELR1Exporter to the US, Manufactureraccessdata.fda.gov
Powder, PorcelainEIH2Manufactureraccessdata.fda.gov
Restoration, Base MetalNSQNExporter to the US, Manufactureraccessdata.fda.gov
Restoration, Noble MetalNSJNExporter to the US, Manufactureraccessdata.fda.gov
Restoration, Porcelain-Fused-To-MetalNSONExporter to the US, Manufactureraccessdata.fda.gov
Restoration, Resin, Crown And BridgeNSNNExporter to the US, Manufactureraccessdata.fda.gov
Rod, Fixation, Intramedullary And AccessoriesHSB2Manufactureraccessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental RestorationsNOF2Exporter to the USaccessdata.fda.gov
Wax, Dental, IntraoralEGD1Exporter to the US, Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
June 5, 2024K240187Tapered Pro Conical Implant SystemDZESubstantially EquivalentBioHorizons Implant Systems, Inc.accessdata.fda.gov
January 22, 2024K233450MegaGen 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 ScrewNHASubstantially EquivalentMegagen Implant Co., Ltd.accessdata.fda.gov
May 15, 2023K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsNHASubstantially EquivalentInstitut Straumann AGaccessdata.fda.gov
April 28, 2023K222636ET Abutment SystemNHASubstantially EquivalentHiossen, Inc.accessdata.fda.gov
March 11, 2022K212628DESS Dental Smart SolutionsNHASubstantially EquivalentTerrats Medical SLaccessdata.fda.gov
January 11, 2022K213391High Retention Attachment SystemNHASubstantially EquivalentZest Anchors, LLCaccessdata.fda.gov
January 7, 2022K203360EK Implants and Abutments SystemDZESubstantially EquivalentHiossen, Inc.accessdata.fda.gov
March 15, 2021K203382Neodent Implant System-Easy PackDZESubstantially EquivalentJjgc Industria E Comercio DE Materiais Dentarios S.A.accessdata.fda.gov
February 12, 2021K203355Straumann TLX Novaloc and Cementable AbutmentsNHASubstantially EquivalentInstitut Straumann AGaccessdata.fda.gov
September 4, 2020K201225Neodent Implant System - GM Helix Implants 7.0DZESubstantially EquivalentJjgc Industria E Comercio DE Materiais Dentarios S.A.accessdata.fda.gov
December 28, 2018K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsDZESubstantially EquivalentInstitut Straumann AGaccessdata.fda.gov
November 29, 2017K171694s-Clean TiN Coating AbutmentsNHASubstantially EquivalentDentis Co., Ltd.accessdata.fda.gov
November 7, 2016K161254Renovo Life Small Bone IM Nail SystemHSBSubstantially EquivalentRenovo Life, LLCaccessdata.fda.gov
January 12, 2016K152509CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)NHASubstantially EquivalentAltatec GmbHaccessdata.fda.gov
December 1, 2015K151295Biodenta Customized Abutment - TitaniumNHASubstantially EquivalentBiodenta Swiss AGaccessdata.fda.gov
July 2, 2015K150296Biodenta Customized Abutment-HybridNHASubstantially EquivalentBiodenta Swiss AGaccessdata.fda.gov
February 17, 2015K143337CONELOG Titanium base CAD/CAMNHASubstantially EquivalentAltatec GmbHaccessdata.fda.gov
December 24, 2013K130572INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEMDZESubstantially EquivalentImplant Direct Sybron Manufacturing, LLCaccessdata.fda.gov
December 14, 2012K113779CONELOG IMPLANT SYSTEMDZESubstantially EquivalentAltatec GmbHaccessdata.fda.gov
June 23, 2011K11158115 ESTHETIC ABUTMENT NOBELACTIVE 03.0 1.5MM, 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 3MM, 15 ESTHETIC ABUTMENT NOBELACTIVENHASubstantially EquivalentNobel Biocare ABaccessdata.fda.gov
April 7, 2009K090723HEX-LOCK SHORT ABUTMENT, MODEL SA341, SA342, SA451, SA452, SA561, SA562 SHORT HEALING CAP, MODEL SAHEAL4, SAHEAL5,NHASubstantially EquivalentZimmer Dental, Inc.accessdata.fda.gov
October 10, 2007K071638BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEMDZESubstantially EquivalentBioHorizons Implant Systems, Inc.accessdata.fda.gov
June 27, 2006K061043ZIMMER CONTOUR RESTORATIVE SYSTEMNHASubstantially EquivalentZimmer Dental, Inc.accessdata.fda.gov
May 19, 2006K060063LEGACY ABUTMENT SYSTEMNHASubstantially EquivalentImplant Direct, LLCaccessdata.fda.gov
June 26, 2002K021045ERA IMPLANTDZESubstantially EquivalentSterngoldaccessdata.fda.gov
December 19, 2001K013798PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEMDZESubstantially EquivalentInstitut Straumann AGaccessdata.fda.gov
November 19, 2001K013227SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANTDZESubstantially EquivalentSulzer Dental, Inc.accessdata.fda.gov

Compare with other makers

Updated June 5, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.