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Silent Nite Sleep Appliance with the Glidewell Hinge

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210694
510(k) Type
Special
Applicant
Prismatik Dentalcraft, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/16/2021
Days to Decision
100 days
Submission Type
Summary

Silent Nite Sleep Appliance with the Glidewell Hinge

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K210694
510(k) Type
Special
Applicant
Prismatik Dentalcraft, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/16/2021
Days to Decision
100 days
Submission Type
Summary