FDA Registration
Active
🇻🇳 Vietnam
Digital Age Dental Laboratories, Ltd.
Reg #: 3007597023
·
FEI: 3007597023
·
Expires 2026
Products
13
Proprietary Names
31
Establishment Types
3
Classifications
13
Registration Details
- Registration Name
- Digital Age Dental Laboratories, Ltd.
- Registration Number
- 3007597023
- FEI Number
- 3007597023
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.19C, 27th Street, VSIP II-A
- City
- Vinh Tan Ward Ho Chi Minh
- Country
- VN
Regulatory Submissions
- 510(k) Number
- K061043
Owner / Operator
- Firm Name
- Digital Age Dental Laboratories, Ltd.
- Operator Number
- 10028093
- Address
- 4400 PGA Blvd, Ste 700
- City
- Palm Beach Gardens
- State
- FL
- Postal Code
- 33410
- Country
- US
US Agent
- Business Name
- Digital Age Dental Labs
- Contact Name
- Ruben Ibarra
- Address
- 2110 Artesia Blvd, B-132
- City
- Redondo Beach
- State
- CA
- ZIP
- 90278
- Country
- US
- [email protected]
- Phone
- 310 2207882
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2025-08-21 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2025-08-21 |
| Post, Root Canal | ELR | Class 1 | Dental | No | 2025-07-08 |
| Dentures, Full | NSL | Class N | Unknown | No | 2008-12-29 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2025-08-20 |
| Restoration, Base Metal | NSQ | Class N | Unknown | No | 2009-05-15 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2024-12-17 |
| Dentures, Partial | NSK | Class N | Unknown | No | 2008-12-29 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2013-04-16 |
| Restoration, Noble Metal | NSJ | Class N | Unknown | No | 2009-05-15 |
| Restoration, Resin, Crown And Bridge | NSN | Class N | Unknown | No | 2008-12-29 |
| Restoration, Porcelain-Fused-To-Metal | NSO | Class N | Unknown | No | 2008-12-29 |
| Powder, Porcelain | EIH | Class 2 | Dental | No | 2025-08-21 |
Proprietary Names
Zimmer Contour Abutments
DESS Ti Base Abutments
Straumann ITI Prosthetic Abutments
Biomet 3i Cast-To Gold Abutments (NP Engaging 3.5 mm 2.9 mm)
Post and Core
CONELOG Inset Abutments
Sterngold ERA Abutments
N/A
Nobel Esthetic Abutments
Biodenta Customized Abutment - Titanium
Hiossen EK Angled Abutments
MegaGen EZ Post Abutments
LOCATOR Abutments (Zest Anchors)
CONELOG Esthomic Abutments
Hiossen Mini ET Transfer Abutments
Ankylos/X Esthetic Abutments
BioHorizons Tapered Pro Conical Implant System (Conical Esthetic Abutments, 0°, 2 mm GH, Narrow platform)
Straumann BLX/Anatomic Abutments
3 Shape Lab Scanner
Zimmer Hex-Lock Abutments
BioHorizons Tapered Internal Implant System (includes 3-in-1 abutments)
Preat Abutments
CONELOG Titanium Base CAD/CAM
Neodent GM Titanium Base Abutments
Implant Direct InterActive Abutments
Biodenta Customized Abutment-Hybrid
Implant Direct Legacy Abutments
Dentis Implant System (including abutments)
Straumann Variobase Abutments
Neodent GM Anatomic Abutments
Straumann Cementable Abutments
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)