# Dentalez, Inc.

- Location (FDA's records): Lancaster, PA
- FDA decisions: 7 (2007–2020): 7 510(k) clearances
- Product codes: EFB (6), EGS (1)
- 510(k) review time since 2016: median 135 days, against 210 for FDA's reviews in the same codes and years (3 of 3 faster)
- Predicates its devices cite: 9 (2 its own); citations of its devices by later devices: 4 (2 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
- Dentalez Group: 3 (https://510kreport.com/company/dentalez-group)
- Scican, Ltd.: 1 (https://510kreport.com/company/scican)
- J. Morita USA, Inc.: 1 (https://510kreport.com/company/j-morita-usa)
- A-Dec, Inc.: 1 (https://510kreport.com/company/a-dec)
- Micro Motors, Inc.: 1 (https://510kreport.com/company/micro-motors)

## Firms that cite its devices most
- Premium Plus International Limited: 1 (https://510kreport.com/company/premium-plus-international)
- Nakamura Magnifier Co., Ltd.: 1 (https://510kreport.com/company/nakamura-magnifier)

## Its most-cited devices
- K070869: Prophy Star 3 Hygiene Handpiece, Model 264422 (2007), cited by 2
- K153411: 430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece (2016), cited by 1
- K113301: Concenpiece,High-Speed Handpiece Series (2012), cited by 1

## Recent decisions
- K192412: SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece (Jan 6, 2020)
- K173465: Concentrix MX-AC High-Speed Handpiece (Mar 28, 2018)
- K162397: Titan 3 Low Speed Angle Attachments (Jan 19, 2017)
- K153411: 430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece (Apr 8, 2016)
- K113301: Concenpiece,High-Speed Handpiece Series (Jan 23, 2012)
- K093072: Starcare Handpiece Maintenance Unit (Dec 28, 2009)
- K070869: Prophy Star 3 Hygiene Handpiece, Model 264422 (Jun 15, 2007)

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