Registered with FDA
DDS Dentalab
Fort Washington, PA, United States. Lists 7 dental device types with FDA across 1 registered establishment.
- Device types listed
- 7
- Brands and models
- 12
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What DDS Dentalab currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Base Metal AlloyEJH · Class 2 | Dental alloys | Lister | NON-PRECIOUS ALLOYPFM NP | 2007 |
| Alloy Other Noble MetalEJS · Class 2 | Dental alloys | Lister | ARTIFICIAL TEETH | 2007 |
| Porcelain TeethELL · Class 2 | Dental ceramics & zirconia | Lister | EMPRESSOPCPROCERAZIRCONIA | 2007 |
| Teeth Plastic DentureELM · Class 2 | Denture resins & teeth | Lister | DENTURETEETH | 2007 |
| Impression MaterialELW · Class 2 | Impression materials | Lister | IMPRESSION MATERIAL | 2007 |
| Dental Chair with Operative UnitKLC · Class 1 | Dental chairs & operative units | Lister | FOSHION DENTAL CHAIR WITH OPERATIVE UNIT | 2013 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Lister | AAA DENTALAB LLC | 2018 |
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
DDS Dentalab 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: Shanghai Foshion Medical Instruments Co., Ltd. (1), Exacta Dental Products, Inc. (1), Nobel Biocare Services AG (1), Austenal, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 14 Dec 2007 | K071353 | FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C | Shanghai Foshion Medical Instruments Co., Ltd. | KLC Dental Chair with Operative Unit |
| 13 Jan 2006 | K053427 | FRESH, DENTAL IMPRESSION MATERIAL | Exacta Dental Products, Inc. | ELW Impression Material |
| 28 May 2004 | K041283 | PROCERA BRIDGE ZIRCONIA | Nobel Biocare Services AG | ELL Porcelain Teeth |
| 4 Nov 1992 | K924526 | DENTURE PLASTIC TEETH | Austenal, Inc. | ELM Teeth Plastic Denture |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DDS DENTALABFDA reg. 3006191485 | Ft Washington, PA, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9105900). 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.