The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Caulk's Vps Cartridge System.
Device ID | K873153 |
510k Number | K873153 |
Device Name: | CAULK'S VPS CARTRIDGE SYSTEM |
Classification | Syringe, Restorative And Impression Material |
Applicant | DENTSPLY INTL. 570 WEST COLLEGE AVE. P.O. BOX 872 York, PA 17405 |
Contact | John O Semmelman |
Correspondent | John O Semmelman DENTSPLY INTL. 570 WEST COLLEGE AVE. P.O. BOX 872 York, PA 17405 |
Product Code | EID |
CFR Regulation Number | 872.4565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-11 |
Decision Date | 1987-09-16 |