The following data is part of a premarket notification filed by Wallace A. Erickson & Co. with the FDA for Centric (bite) Registration Paste.
Device ID | K810498 |
510k Number | K810498 |
Device Name: | CENTRIC (BITE) REGISTRATION PASTE |
Classification | Paper, Articulation |
Applicant | WALLACE A. ERICKSON & CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EFH |
CFR Regulation Number | 872.6140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-02-24 |
Decision Date | 1981-03-17 |