Data / Medical devices / United States / DDS Dentalab
DDS Dentalab: FDA-registered device maker in Ft Washington, PA, United States, 4 510(k) clearances
DDS Dentalab is registered with the FDA (registration 3006191485) in Ft Washington, PA, United States. It lists 7 device types. The FDA files 4 510(k) clearances under its listings, the newest dated December 14, 2007. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006191485
- Address
- 260 New York Dr --SUITE 403, Ft Washington, PA, United States, 19034
- Owner or operator
- DDS DENTALAB (9105900)
- Roles
- Repackager or relabeler
- First device listed
- August 15, 2007
- Registered through
- 2026
- Brand names listed
- AAA DENTALAB LLC, ARTIFICIAL TEETH, DENTURE, EMPRESS, FOSHION DENTAL CHAIR WITH OPERATIVE UNIT, IMPRESSION MATERIAL, NON-PRECIOUS ALLOY, OPC and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Alloy, Metal, Base | EJH | 2 | Repackager or relabeler | accessdata.fda.gov |
| Alloy, Other Noble Metal | EJS | 2 | Repackager or relabeler | accessdata.fda.gov |
| Chair, Dental, With Operative Unit | KLC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Denture, Plastic, Teeth | ELM | 2 | Repackager or relabeler | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Repackager or relabeler | accessdata.fda.gov |
| Teeth, Porcelain | ELL | 2 | Repackager or relabeler | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 14, 2007 | K071353 | FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C | KLC | Substantially Equivalent | Shanghai Foshion Medical Instruments Co., Ltd. | accessdata.fda.gov |
| January 13, 2006 | K053427 | FRESH, DENTAL IMPRESSION MATERIAL | ELW | Substantially Equivalent | Exacta Dental Products, Inc. | accessdata.fda.gov |
| May 28, 2004 | K041283 | PROCERA BRIDGE ZIRCONIA | ELL | Substantially Equivalent | Nobel Biocare AB | accessdata.fda.gov |
| November 4, 1992 | K924526 | DENTURE PLASTIC TEETH | ELM | Substantially Equivalent | Austenal, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Alloy, Metal, Base
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Alloy, Other Noble Metal
- All makers of Denture, Plastic, Teeth
- All makers of Material, Impression
- All makers of Teeth, Porcelain
Updated December 14, 2007. 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.