The following data is part of a premarket notification filed by Bien-air Dental, Sa with the FDA for Chiropro L System.
| Device ID | K092214 |
| 510k Number | K092214 |
| Device Name: | CHIROPRO L SYSTEM |
| Classification | Controller, Foot, Handpiece And Cord |
| Applicant | BIEN-AIR DENTAL, SA 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Cynthia J Nolte |
| Correspondent | Cynthia J Nolte BIEN-AIR DENTAL, SA 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | EBW |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-22 |
| Decision Date | 2009-12-15 |
| Summary: | summary |