The following data is part of a premarket notification filed by Crown Delta Corp. with the FDA for Tryout-vps Holding Paste.
Device ID | K122974 |
510k Number | K122974 |
Device Name: | TRYOUT-VPS HOLDING PASTE |
Classification | Cement, Dental |
Applicant | CROWN DELTA CORP. 1550 FRONT ST. Yorktown Heights, NY 10598 |
Contact | Mark Konopka |
Correspondent | Mark Konopka CROWN DELTA CORP. 1550 FRONT ST. Yorktown Heights, NY 10598 |
Product Code | EMA |
CFR Regulation Number | 872.3275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-09-26 |
Decision Date | 2013-05-17 |