The following data is part of a premarket notification filed by Ivoclar Vivadent, Inc. with the FDA for Systemp.c&b Plus.
Device ID | K042820 |
510k Number | K042820 |
Device Name: | SYSTEMP.C&B PLUS |
Classification | Crown And Bridge, Temporary, Resin |
Applicant | IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
Contact | Donna Hartnett |
Correspondent | Donna Hartnett IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
Product Code | EBG |
CFR Regulation Number | 872.3770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-10-12 |
Decision Date | 2004-12-14 |