The following data is part of a premarket notification filed by Syntex Dental Products, Inc. with the FDA for Vibratory Endodontic System.
| Device ID | K832378 |
| 510k Number | K832378 |
| Device Name: | VIBRATORY ENDODONTIC SYSTEM |
| Classification | Preparer, Root Canal Endodontic |
| Applicant | SYNTEX DENTAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EKQ |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-19 |
| Decision Date | 1983-10-04 |