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Bio-TackS Orthodontic Mini Implant

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190871
510(k) Type
Traditional
Applicant
Bio Cetec Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
1/17/2020
Days to Decision
289 days
Submission Type
Summary

Bio-TackS Orthodontic Mini Implant

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190871
510(k) Type
Traditional
Applicant
Bio Cetec Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
1/17/2020
Days to Decision
289 days
Submission Type
Summary