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Custom Legacy and Custom InterActive Titanium Abutments

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192218
510(k) Type
Traditional
Applicant
Implant Direct Sybron Manufacturing , LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/8/2020
Days to Decision
267 days
Submission Type
Summary

Custom Legacy and Custom InterActive Titanium Abutments

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192218
510(k) Type
Traditional
Applicant
Implant Direct Sybron Manufacturing , LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/8/2020
Days to Decision
267 days
Submission Type
Summary