Last synced on 23 September 2022 at 11:05 pm

Krystal Klear Aligners

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K182388
510(k) Type
Traditional
Applicant
Shatkin F.I.R.S.T. LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/19/2019
Days to Decision
471 days
Submission Type
Summary

Krystal Klear Aligners

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K182388
510(k) Type
Traditional
Applicant
Shatkin F.I.R.S.T. LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/19/2019
Days to Decision
471 days
Submission Type
Summary