Data / Medical devices / United States / Emery Enterprises Inc.
Emery Enterprises Inc.: FDA-registered device maker in Irvine, CA, United States, 1 510(k) clearance
Emery Enterprises Inc. is registered with the FDA (registration 2086964) in Irvine, CA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 20, 1996. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2086964
- FEI number
- 3003054571
- Address
- 31 Peters Canyon Rd, Irvine, CA, United States, 92606
- Owner or operator
- EMERY ENTERPRISES INC.dba ITL Dental (9094606)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- November 14, 2006
- Registered through
- 2026
- Brand names listed
- PRECISE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| March 20, 1996 | K960110 | KIS MT3 | DZE | Substantially Equivalent | The Implant Center of the Palm Beaches | accessdata.fda.gov |
Compare with other makers
Updated March 20, 1996. 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.