The following data is part of a premarket notification filed by Mission White Dental, Inc. with the FDA for Dental Prophy Cups (various Types).
| Device ID | K864059 |
| 510k Number | K864059 |
| Device Name: | DENTAL PROPHY CUPS (VARIOUS TYPES) |
| Classification | Cup, Prophylaxis |
| Applicant | MISSION WHITE DENTAL, INC. 31 PARK RD. Tinton Falls, NJ 07724 |
| Contact | Joseph J Butler |
| Correspondent | Joseph J Butler MISSION WHITE DENTAL, INC. 31 PARK RD. Tinton Falls, NJ 07724 |
| Product Code | EHK |
| CFR Regulation Number | 872.6290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-20 |
| Decision Date | 1986-11-19 |