The following data is part of a premarket notification filed by Degussa Dental, Inc. with the FDA for Resistal P.
Device ID | K862870 |
510k Number | K862870 |
Device Name: | RESISTAL P |
Classification | Alloy, Metal, Base |
Applicant | DEGUSSA DENTAL, INC. 21-25 44TH AVE. Long Island, NY 11101 |
Contact | Manohar Malhotra,phd |
Correspondent | Manohar Malhotra,phd DEGUSSA DENTAL, INC. 21-25 44TH AVE. Long Island, NY 11101 |
Product Code | EJH |
CFR Regulation Number | 872.3710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-07-29 |
Decision Date | 1986-08-15 |