Device Classification Name |
handpiece, belt and/or gear driven, dental
|
510(k) Number |
K960260 |
Device Name |
STAR TITAN SERIES MOTORS & ATTACHMENTS |
Applicant |
DENTALEZ GROUP |
1816 COLONIAL VILLAGE LN. |
LANCASTER,
PA
17601
|
|
Applicant Contact |
JEFF PEINHARDT |
Correspondent |
DENTALEZ GROUP |
1816 COLONIAL VILLAGE LN. |
LANCASTER,
PA
17601
|
|
Correspondent Contact |
JEFF PEINHARDT |
Regulation Number | 872.4200
|
Classification Product Code |
|
Date Received | 01/18/1996 |
Decision Date | 03/28/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|