Last synced on 25 January 2026 at 3:41 am

BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K121131
510(k) Type
Traditional
Applicant
Straumann USA
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/6/2012
Days to Decision
54 days
Submission Type
Summary

BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K121131
510(k) Type
Traditional
Applicant
Straumann USA
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/6/2012
Days to Decision
54 days
Submission Type
Summary