Data / Medical devices / United States / Open Implants
Open Implants: FDA-registered device maker in Santa Ana, CA, United States, 4 510(k) clearances
Open Implants is registered with the FDA (registration 3027595870) in Santa Ana, CA, United States. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated June 26, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027595870
- Address
- 2850 Red Hill Ave Suite 210, Santa Ana, CA, United States, 92705
- Owner or operator
- Open Implants (10089590)
- Roles
- Manufacturer
- First device listed
- December 20, 2023
- Registered through
- 2026
- Brand names listed
- Neodent Grand Morse, Sherlock Abutment, Sherlock Accessories
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | 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 |
|---|---|---|---|---|---|---|
| June 26, 2025 | K250967 | Sherlock | NHA | Substantially Equivalent | Open Implants, LLC | accessdata.fda.gov |
| June 21, 2022 | K220482 | Sherlock | NHA | Substantially Equivalent | Open Implants, LLC | accessdata.fda.gov |
| November 30, 2021 | K212664 | Sherlock | NHA | Substantially Equivalent | Open Implants, LLC | accessdata.fda.gov |
| March 24, 2020 | K193335 | Sherlock | NHA | Substantially Equivalent | Open Implants, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Abutment, Implant, Dental, Endosseous
Updated June 26, 2025. 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.