The following data is part of a premarket notification filed by Dental Crafters with the FDA for Ist Snoring Appliance.
| Device ID | K090911 |
| 510k Number | K090911 |
| Device Name: | IST SNORING APPLIANCE |
| Classification | Device, Jaw Repositioning |
| Applicant | DENTAL CRAFTERS P.O. BOX 770 Marshfeld, WI 54449 |
| Contact | Amy Nystrom |
| Correspondent | Amy Nystrom DENTAL CRAFTERS P.O. BOX 770 Marshfeld, WI 54449 |
| Product Code | LQZ |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-01 |
| Decision Date | 2009-09-11 |
| Summary: | summary |