The following data is part of a premarket notification filed by Dental Resources with the FDA for Dr Disposable Prophy Angle Model H310.
| Device ID | K060377 |
| 510k Number | K060377 |
| Device Name: | DR DISPOSABLE PROPHY ANGLE MODEL H310 |
| Classification | Handpiece, Contra- And Right-angle Attachment, Dental |
| Applicant | DENTAL RESOURCES 400 CONGRESS ST. W. Maple Lake, MN 55358 |
| Contact | Bryan Nichols |
| Correspondent | Bryan Nichols DENTAL RESOURCES 400 CONGRESS ST. W. Maple Lake, MN 55358 |
| Product Code | EGS |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-14 |
| Decision Date | 2006-04-26 |
| Summary: | summary |