The following data is part of a premarket notification filed by Kavo America Corporation with the FDA for Diagnodent Perio Tip (accessory).
| Device ID | K042394 |
| 510k Number | K042394 |
| Device Name: | DIAGNODENT PERIO TIP (ACCESSORY) |
| Classification | Laser, Fluorescence Caries Detection |
| Applicant | KAVO AMERICA CORPORATION PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm KAVO AMERICA CORPORATION PO BOX 7007 Deerfield, IL 60015 |
| Product Code | NBL |
| CFR Regulation Number | 872.1745 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-02 |
| Decision Date | 2005-08-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKAV100416400 | K042394 | 000 |