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 |