Star E900 Electric System
FDA 510(k) K251701 · Dentalez, Inc., Stardental Division
510(k) numberK251701
Submission
- Device name
- Star E900 Electric System
- Applicant
- Dentalez, Inc., Stardental Division
Lancaster, PA, US - Received
- June 2, 2025
- Decision date
- January 12, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Foshan Coxo Medical Instrument Co., Ltd.
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|---|---|---|
| K240183 | Star E900 Handpiece SeriesEGS · Traditional | 09/19/2024SE |
Questions and answers
When was Star E900 Electric System cleared by the FDA?
Star E900 Electric System (K251701) received a 510(k) decision of Substantially Equivalent on January 12, 2026, 224 days after the submission was received.
What is the product code of K251701?
The FDA product code is EBW – Controller, Foot, Handpiece And Cord, a Class I (low risk) device regulated under 21 CFR 872.4200.