| Device Classification Name |
Cup, Prophylaxis
|
| 510(k) Number |
K864059 |
| Device Name |
DENTAL PROPHY CUPS (VARIOUS TYPES) |
| Applicant |
| Mission White Dental, Inc. |
| 31 Park Rd. |
|
Tinton Falls,
NJ
07724
|
|
| Applicant Contact |
JOSEPH J BUTLER |
| Correspondent |
| Mission White Dental, Inc. |
| 31 Park Rd. |
|
Tinton Falls,
NJ
07724
|
|
| Correspondent Contact |
JOSEPH J BUTLER |
| Regulation Number | 872.6290 |
| Classification Product Code |
|
| Date Received | 10/20/1986 |
| Decision Date | 11/19/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Dental
|
| 510k Review Panel |
Dental
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|