Device Classification Name |
laser, fluorescence caries detection
|
510(k) Number |
K150672 |
Device Name |
VistaCam iX Proof |
Applicant |
Durr Dental AG |
Hopfigheimer Strasse 17 |
Bietigheim-Bissingen,
DE
D-74321
|
|
Applicant Contact |
Oliver Lange |
Correspondent |
AIR TECHNIQUES, INC. |
1295 WALT WHITMAN RD. |
MELVILLE,
NY
11747
|
|
Correspondent Contact |
Pablo Martinez |
Regulation Number | 872.1745
|
Classification Product Code |
|
Date Received | 03/16/2015 |
Decision Date | 01/27/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|