The following data is part of a premarket notification filed by Centrix, Inc. with the FDA for Dental Syringe System-various Styles.
| Device ID | K832662 |
| 510k Number | K832662 |
| Device Name: | DENTAL SYRINGE SYSTEM-VARIOUS STYLES |
| Classification | Applicator, Resin |
| Applicant | CENTRIX, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KXR |
| CFR Regulation Number | 872.3140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-08 |
| Decision Date | 1983-10-04 |