# Open Implants, LLC

- Location (FDA's records): Woburn, MA
- FDA decisions: 4 (2020–2025): 4 510(k) clearances
- Product codes: NHA (4)
- 510(k) review time since 2016: median 106 days, against 150 for FDA's reviews in the same codes and years (4 of 4 faster)
- Predicates its devices cite: 4 (3 its own); citations of its devices by later devices: 3 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Preat Corporation: 1 (https://510kreport.com/company/preat)

## Its most-cited devices
- K212664: Sherlock (2021), cited by 1
- K193335: Sherlock (2020), cited by 1
- K220482: Sherlock (2022), cited by 1

## Recent decisions
- K250967: Sherlock (Jun 26, 2025)
- K220482: Sherlock (Jun 21, 2022)
- K212664: Sherlock (Nov 30, 2021)
- K193335: Sherlock (Mar 24, 2020)

Source page: https://510kreport.com/company/open-implants