| Device Classification Name |
Handpiece, Contra- And Right-Angle Attachment, Dental
|
| 510(k) Number |
K923980 |
| Device Name |
Q3 DISPOSABLE PROPHY ANGLE |
| Applicant |
| Q3 Special Products, Inc. |
| 511 Sarah Ln. |
|
St. Louis,
MO
63141
|
|
| Applicant Contact |
DAVID KRAENZLE |
| Correspondent |
| Q3 Special Products, Inc. |
| 511 Sarah Ln. |
|
St. Louis,
MO
63141
|
|
| Correspondent Contact |
DAVID KRAENZLE |
| Regulation Number | 872.4200 |
| Classification Product Code |
|
| Date Received | 08/07/1992 |
| Decision Date | 05/27/1993 |
| 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
|
|
|