The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Partial Denture Alloy.
Device ID | K860437 |
510k Number | K860437 |
Device Name: | PARTIAL DENTURE ALLOY |
Classification | Alloy, Metal, Base |
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 | EJH |
CFR Regulation Number | 872.3710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-04 |
Decision Date | 1986-03-17 |