Device Classification Name |
scaler, rotary
|
510(k) Number |
K121114 |
Device Name |
TIGRAN PERIBRUSH |
Applicant |
TIGRAN TECHNOLOGIES AB |
Medeon Science Park |
Malmo,
SE
205 12
|
|
Applicant Contact |
ULF LUNDGREN |
Correspondent |
TIGRAN TECHNOLOGIES AB |
Medeon Science Park |
Malmo,
SE
205 12
|
|
Correspondent Contact |
ULF LUNDGREN |
Regulation Number | 872.4840
|
Classification Product Code |
|
Date Received | 04/12/2012 |
Decision Date | 09/17/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|