The following data is part of a premarket notification filed by Premier Dental Company Products with the FDA for Aeropro Cordless Prophy System.
| Device ID | K180682 |
| 510k Number | K180682 |
| Device Name: | AeroPro Cordless Prophy System |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | Premier Dental Company Products 1710 Romano Drive Plymouth Meeting, PA 19462 |
| Contact | Noel Hetrick |
| Correspondent | Cara Braslow Premier Dental Company Products 1710 Romano Drive Plymouth Meeting, PA 19462 -4500 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-15 |
| Decision Date | 2019-02-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D691550005200 | K180682 | 000 |