The following data is part of a premarket notification filed by Foremost Dental Mfg., Inc. with the FDA for Honigum Automix Impression Material (foil Bags) And Honigum Quick Impression Material (cartridges).
| Device ID | K980963 |
| 510k Number | K980963 |
| Device Name: | HONIGUM AUTOMIX IMPRESSION MATERIAL (FOIL BAGS) AND HONIGUM QUICK IMPRESSION MATERIAL (CARTRIDGES) |
| Classification | Material, Impression |
| Applicant | FOREMOST DENTAL MFG., INC. 415 W. ALDINE AVE. 10-A Chicago, IL 60657 |
| Contact | An-shih Cheng |
| Correspondent | An-shih Cheng FOREMOST DENTAL MFG., INC. 415 W. ALDINE AVE. 10-A Chicago, IL 60657 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-16 |
| Decision Date | 1998-05-11 |