The following data is part of a premarket notification filed by Young Dental Manufacturing Co 1, Llc. with the FDA for Prophylaxis Cups And Polishers.
Device ID | K790723 |
510k Number | K790723 |
Device Name: | PROPHYLAXIS CUPS AND POLISHERS |
Classification | Cup, Prophylaxis |
Applicant | YOUNG DENTAL MANUFACTURING CO 1, LLC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EHK |
CFR Regulation Number | 872.6290 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-04-10 |
Decision Date | 1979-06-15 |