The following data is part of a premarket notification filed by Medtrol, Inc. with the FDA for Medtrol Dental Kit.
| Device ID | K953707 |
| 510k Number | K953707 |
| Device Name: | MEDTROL DENTAL KIT |
| Classification | Burnisher, Operative |
| Applicant | MEDTROL, INC. 2126 BERWICK Inverness, IL 60067 |
| Contact | Bruce J Schullo |
| Correspondent | Bruce J Schullo MEDTROL, INC. 2126 BERWICK Inverness, IL 60067 |
| Product Code | EKJ |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-08 |
| Decision Date | 1996-01-04 |