The following data is part of a premarket notification filed by Fly Cast Technologies, Inc. with the FDA for Dental Matrix Band.
| Device ID | K071858 |
| 510k Number | K071858 |
| Device Name: | DENTAL MATRIX BAND |
| Classification | Instruments, Dental Hand |
| Applicant | FLY CAST TECHNOLOGIES, INC. P.O. BOX 848 Grayslake, IL 60030 |
| Contact | Michele H Vovolka |
| Correspondent | Michele H Vovolka FLY CAST TECHNOLOGIES, INC. P.O. BOX 848 Grayslake, IL 60030 |
| Product Code | DZN |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-05 |
| Decision Date | 2007-08-31 |
| Summary: | summary |