| Device Classification Name |
Cleaner, Denture, Mechanical
|
| 510(k) Number |
K883403 |
| Device Name |
DENTA PLUS |
| Applicant |
| Connoisseurs Products Corp. |
| 100 Fellsway W. |
|
Somerville,
MA
02145
|
|
| Applicant Contact |
KARL KALTENBACH |
| Correspondent |
| Connoisseurs Products Corp. |
| 100 Fellsway W. |
|
Somerville,
MA
02145
|
|
| Correspondent Contact |
KARL KALTENBACH |
| Regulation Number | 872.3530 |
| Classification Product Code |
|
| Date Received | 08/11/1988 |
| Decision Date | 10/25/1988 |
| 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
|
|
|