The following data is part of a premarket notification filed by Air Force, Inc. with the FDA for Dental Air Force Home Dental Cleaning System, Model No. 0020001.
| Device ID | K001493 |
| 510k Number | K001493 |
| Device Name: | DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001 |
| Classification | Unit, Oral Irrigation |
| Applicant | AIR FORCE, INC. 933 BUTTERNUT DR. Holland, MI 49424 |
| Contact | Piero Policicchio |
| Correspondent | Piero Policicchio AIR FORCE, INC. 933 BUTTERNUT DR. Holland, MI 49424 |
| Product Code | EFS |
| CFR Regulation Number | 872.6510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-12 |
| Decision Date | 2000-10-25 |