The following data is part of a premarket notification filed by Smart Practice with the FDA for Splatrfree Swangle 360 Disposable Prophylaxis Angle.
| Device ID | K023232 |
| 510k Number | K023232 |
| Device Name: | SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE |
| Classification | Unit, Oral Irrigation |
| Applicant | SMART PRACTICE 3400 EAST MCDOWELL RD. Phoenix, AZ 85008 |
| Contact | Kim Sullivan |
| Correspondent | Kim Sullivan SMART PRACTICE 3400 EAST MCDOWELL RD. Phoenix, AZ 85008 |
| Product Code | EFS |
| CFR Regulation Number | 872.6510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-27 |
| Decision Date | 2002-12-11 |