The following data is part of a premarket notification filed by Mirage Dental Systems with the FDA for Mirage Complete Kit And Mirage Abc Kit.
| Device ID | K915511 |
| 510k Number | K915511 |
| Device Name: | MIRAGE COMPLETE KIT AND MIRAGE ABC KIT |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | MIRAGE DENTAL SYSTEMS 200 NORTH 6TH ST. Kansas City, KS 66101 |
| Contact | Timothy Sigler |
| Correspondent | Timothy Sigler MIRAGE DENTAL SYSTEMS 200 NORTH 6TH ST. Kansas City, KS 66101 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-09 |
| Decision Date | 1992-03-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850015110313 | K915511 | 000 |