Data / Medical devices / United States / Streamline Dental Products Inc.
Streamline Dental Products Inc.: FDA-registered device maker in New York, NY, United States, 1 510(k) clearance
Streamline Dental Products Inc. is registered with the FDA (registration 3007028587) in New York, NY, United States. It lists 9 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 8, 2020. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3007028587
- Address
- 237 W 37th St Fl 2, New York, NY, United States, 10018
- Owner or operator
- Streamline Dental Laboratory (10025166)
- Roles
- Repackager or relabeler
- First device listed
- August 15, 2018
- Registered through
- 2027
- Brand names listed
- ALL CERAMIC, CAD/CAM RESTORATION, FULL CAST BASE, FULL DENTURE, PARTIAL DENTURES, PFM GENERAL, PFM NOBLE, PROVISIONAL
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dentures, Full | NSL | N | Repackager or relabeler | accessdata.fda.gov |
| Dentures, Partial | NSK | N | Repackager or relabeler | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Repackager or relabeler | accessdata.fda.gov |
| Restoration, Base Metal | NSQ | N | Repackager or relabeler | accessdata.fda.gov |
| Restoration, Noble Metal | NSJ | N | Repackager or relabeler | accessdata.fda.gov |
| Restoration, Porcelain | NSP | N | Repackager or relabeler | accessdata.fda.gov |
| Restoration, Porcelain-Fused-To-Metal | NSO | N | Repackager or relabeler | accessdata.fda.gov |
| Restoration, Resin | NSM | N | Repackager or relabeler | accessdata.fda.gov |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | 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 |
|---|---|---|---|---|---|---|
| October 8, 2020 | K201483 | Impression Material | ELW | Substantially Equivalent | Zhengzhou Huaer Electro Optics Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Restoration, Base Metal
- All makers of Dentures, Full
- All makers of Material, Impression
- All makers of Restoration, Resin
- All makers of System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
- All makers of Restoration, Noble Metal
Updated October 8, 2020. 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.