The following data is part of a premarket notification filed by Heany Industries Inc with the FDA for Heany Industries Inc Dental Xirconia.
Device ID | K073314 |
510k Number | K073314 |
Device Name: | HEANY INDUSTRIES INC DENTAL XIRCONIA |
Classification | Powder, Porcelain |
Applicant | HEANY INDUSTRIES INC 249 BRIARWOOD LANE Scottsville, NY 14546 |
Contact | Corey Dunn |
Correspondent | Corey Dunn HEANY INDUSTRIES INC 249 BRIARWOOD LANE Scottsville, NY 14546 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-11-26 |
Decision Date | 2008-02-21 |
Summary: | summary |