The following data is part of a premarket notification filed by Discus Dental, Llc with the FDA for Zen Cordless Prophy System.
| Device ID | K101612 |
| 510k Number | K101612 |
| Device Name: | ZEN CORDLESS PROPHY SYSTEM |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | DISCUS DENTAL, LLC 8550 HIGUERA ST. Culver City, CA 90232 |
| Contact | Winkie Wong |
| Correspondent | Jeff D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-06-09 |
| Decision Date | 2010-06-30 |