The following data is part of a premarket notification filed by Kavo America with the FDA for Prophypearls.
| Device ID | K031868 |
| 510k Number | K031868 |
| Device Name: | PROPHYPEARLS |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | KAVO AMERICA PO BOX 7007 Deer Field, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm KAVO AMERICA PO BOX 7007 Deer Field, IL 60015 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-17 |
| Decision Date | 2003-07-09 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PROPHYPEARLS 76502681 2822710 Live/Registered |
KALTENBACH & VOIGT GMBH 2003-04-01 |