| Device Classification Name |
Attachment, Precision, All
|
| 510(k) Number |
K891119 |
| Device Name |
T.R.S.: TOOTH REPLACEMENT SYSTEM |
| Applicant |
| Health Technology of America, Inc. |
| 301 W. 53rd St. |
| Apt. 21k |
|
New York,
NY
10019
|
|
| Applicant Contact |
HOWARD MARSHALL |
| Correspondent |
| Health Technology of America, Inc. |
| 301 W. 53rd St. |
| Apt. 21k |
|
New York,
NY
10019
|
|
| Correspondent Contact |
HOWARD MARSHALL |
| Regulation Number | 872.3165 |
| Classification Product Code |
|
| Date Received | 03/02/1989 |
| Decision Date | 04/17/1989 |
| 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
|
|
|