# Pearl, Inc.

- Location (FDA's records): Beverly Hills, CA
- FDA decisions: 8 (2022–2025): 8 510(k) clearances
- Product codes: MYN (6), QIH (2)
- 510(k) review time since 2016: median 219 days, against 210 for FDA's reviews in the same codes and years (3 of 8 faster)
- Predicates its devices cite: 12 (5 its own); citations of its devices by later devices: 11 (5 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
- Overjet, Inc.: 4 (https://510kreport.com/company/overjet)
- Relu BV: 1 (https://510kreport.com/company/relu)
- Denti.Ai Technology, Inc.: 1 (https://510kreport.com/company/denti-ai-technology)
- Carestream Dental, LLC: 1 (https://510kreport.com/company/carestream-dental)

## Firms that cite its devices most
- Denti.Ai Technology, Inc.: 1 (https://510kreport.com/company/denti-ai-technology)
- Overjet, Inc.: 1 (https://510kreport.com/company/overjet)
- Nobel Biocare AB: 1 (https://510kreport.com/company/nobel-biocare)
- Velmeni, Inc.: 1 (https://510kreport.com/company/velmeni)
- Dentsply Sirona: 1 (https://510kreport.com/company/dentsply-sirona)
- Better Diagnostics AI Corp.: 1 (https://510kreport.com/company/better-diagnostics-ai)

## Its most-cited devices
- K210365: Second Opinion (2022), cited by 9
- K243989: Second Opinion® 3D (2025), cited by 2

## Recent decisions
- K250525: Second Opinion® Panoramic (Nov 14, 2025)
- K243234: Second Opinion® CS (Jun 12, 2025)
- K243989: Second Opinion® 3D (May 23, 2025)
- K243230: Second Opinion® BLE (May 9, 2025)
- K243893: Second Opinion® Pediatric (May 5, 2025)
- K242600: Second Opinion Periapical Radiolucency Contours (Apr 11, 2025)
- K242522: Second Opinion CC (Jan 16, 2025)
- K210365: Second Opinion (Mar 4, 2022)

Source page: https://510kreport.com/company/pearl