The following data is part of a premarket notification filed by Hti, Inc. with the FDA for Fogcutter Dental Mouth Mirror.
| Device ID | K833310 |
| 510k Number | K833310 |
| Device Name: | FOGCUTTER DENTAL MOUTH MIRROR |
| Classification | Mirror, Mouth |
| Applicant | HTI, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EAX |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-26 |
| Decision Date | 1984-05-07 |