Dentalez, Inc., Stardental Division · Class I · Cleared Jan 12, 2026
| K-number | K251701 |
| Device name | Star E900 Electric System |
| Applicant | Dentalez, Inc., Stardental Division |
| Product code | EBW |
| Device class | Class I |
| Decision date | Jan 12, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 872.4200 |
The Star E900 Electric System is a dental handpiece system comprising a power supply, control unit, cable, and brushless micromotor for use by dental professionals in dental restoration, prophylaxis, and endodontic procedures. It operates at 100–40,000 rpm with forward and reverse rotation, offers two operating modes with customizable profiles, and includes LED lighting with variable intensity.
The device shares the same intended use, power source, RFID technology, and motor overcurrent sensing as its predicate. Key differences include temperature sensing software to detect handpiece temperature and cellular connectivity for system monitoring and software updates, neither of which affects device performance.
ISO 14457:2017 (Dentistry – Handpieces and Motors), IEC 60601-1:2005 Ed 3+A1;A2 (Medical Electrical Equipment – Basic Safety), IEC 60601-1-2:2014 A1:2020 (Electromagnetic Compatibility), IEC 60601-1-6:2010 (Usability), IEC 80601-2-60:2019 Ed. 2 (Dental Equipment), ANSI/AAMI ST79:2010 & A4:2013 (Sterilization), and ISO 14971:2012 (Risk Management).
The Star E900 Electric System is substantially equivalent to the NLZ Motor System (K163402) predicate because both devices share identical indications for use, design principles, and core technological characteristics including electronic micromotor drive, LED lighting, and temperature/overcurrent sensing. Minor differences in cellular connectivity and temperature sensing software do not affect performance or indications for use, as demonstrated by conformity to applicable standards and bench testing.
View the full FDA submission: accessdata.fda.gov