The following data is part of a premarket notification filed by Di-equi Dental Products with the FDA for Crown Index Tray.
Device ID | K842273 |
510k Number | K842273 |
Device Name: | CROWN INDEX TRAY |
Classification | Tray, Impression, Preformed |
Applicant | DI-EQUI DENTAL PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EHY |
CFR Regulation Number | 872.6880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-06-08 |
Decision Date | 1984-07-31 |