Device Classification Name |
unit, x-ray, extraoral with timer
|
510(k) Number |
K992610 |
Device Name |
GENDEX 765DC, MODEL 110-0154 |
Applicant |
DENTSPLY INTL. |
901 WEST OAKTON ST. |
DES PLAINES,
IL
60018 -1884
|
|
Applicant Contact |
DANIEL P MURPHY |
Correspondent |
DENTSPLY INTL. |
901 WEST OAKTON ST. |
DES PLAINES,
IL
60018 -1884
|
|
Correspondent Contact |
DANIEL P MURPHY |
Regulation Number | 872.1800
|
Classification Product Code |
|
Date Received | 08/04/1999 |
Decision Date | 09/07/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|