Data / Medical devices / United States / Crown Delta Corp.
Crown Delta Corp.: FDA-registered device maker in Yorktown, NY, United States, 8 510(k) clearances
Crown Delta Corp. is registered with the FDA (registration 2431069) in Yorktown, NY, United States. It lists 6 device types. The FDA files 8 510(k) clearances under its listings, the newest dated May 14, 2004. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2431069
- Address
- 1520 Front ST., Yorktown, NY, United States, 10598
- Owner or operator
- CROWN DELTA CORP. (2431069)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- November 28, 2007
- Registered through
- 2026
- Brand names listed
- Impression Material Syringe, Podiatric Impression Material, Silicone Elastomer Putty, VPS Silicone Adhesive, Vinyl Silicone Material, ZerofloX
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Resin | KXR | 1 | Manufacturer | accessdata.fda.gov |
| Cord, Retraction | MVL | U | Contract manufacturer | accessdata.fda.gov |
| Elastomer, Silicone, For Scar Management | MDA | 1 | Manufacturer | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Orthosis, Moldable, Supportive, Skin Protective | MNE | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Restorative And Impression Material | EID | 1 | 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 |
|---|---|---|---|---|---|---|
| May 14, 2004 | K041028 | CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL | ELW | Substantially Equivalent | Crown Delta Corp. | accessdata.fda.gov |
| November 2, 1999 | K992001 | TRAY-LINK | ELW | Substantially Equivalent | Silicon-Und Composite Spezialitaten GmbH | accessdata.fda.gov |
| September 29, 1994 | K940132 | PODIATRIC MATERIAL | MNE | Substantially Equivalent | Crown Delta Corp. | accessdata.fda.gov |
| January 7, 1994 | K930248 | VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEM | ELW | Substantially Equivalent | Crown Delta Corp. | accessdata.fda.gov |
| September 14, 1990 | K901991 | SILICONE ELASTOMER PUTTY | MDA | Substantially Equivalent | Crown Delta Corp. | accessdata.fda.gov |
| September 14, 1990 | K901990 | VINYL SILICONE ELASTOMER MATERIAL | MDA | Substantially Equivalent | Crown Delta Corp. | accessdata.fda.gov |
| June 7, 1982 | K821221 | DENTAL IMPRESSION MATERIAL | ELW | Substantially Equivalent | Crown Delta Corp. | accessdata.fda.gov |
| July 8, 1980 | K801380 | CROWN DELTA SILICONE IMPRESSION MATERIAL | ELW | Substantially Equivalent | Crown Delta Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Elastomer, Silicone, For Scar Management
- All makers of Material, Impression
- All makers of Applicator, Resin
- All makers of Syringe, Restorative And Impression Material
- All makers of Cord, Retraction
- All makers of Orthosis, Moldable, Supportive, Skin Protective
Updated May 14, 2004. 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.