| Device Classification Name |
implant, endosseous, root-form
|
|---|
| 510(K) Number |
K122855 |
|---|
| Models |
033.530S,531S,532S,533S,534S,535S,
033.560S,561S,562S,563S,564S,
033.571S,.572S,.573S,.574S,
033.580S,581S,582S,583S 584S,
033.590S,.5918,592S,593S,594S
|
| Device Name |
TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS |
|---|
| Applicant |
| STRAUMANN USA |
| 60 minuteman road |
|
andover,
MA
01810
|
|
| Contact |
elaine alan |
| Regulation Number | 872.3640
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 09/18/2012 |
|---|
| Decision Date | 12/12/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Dental
|
|---|
| Review Advisory Committee |
Dental
|
|---|
| summary |
summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
