The following data is part of a premarket notification filed by Beyes Dental Canada Inc with the FDA for Easyprophy Series Air Polish Devices, Models Easyprophy 200 And Easyprophy 400.
| Device ID | K112869 |
| 510k Number | K112869 |
| Device Name: | EASYPROPHY SERIES AIR POLISH DEVICES, MODELS EASYPROPHY 200 AND EASYPROPHY 400 |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | BEYES DENTAL CANADA INC 3500 SOUTH DUPONT HIGHWAY Dover, DE 19901 |
| Contact | Anthony Hopkins |
| Correspondent | Anthony Hopkins BEYES DENTAL CANADA INC 3500 SOUTH DUPONT HIGHWAY Dover, DE 19901 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-30 |
| Decision Date | 2011-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00837699001168 | K112869 | 000 |
| 00990010302358 | K112869 | 000 |