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Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K233434
510(k) Type
Special
Applicant
Prismatik Dentalcraft, Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/14/2023
Days to Decision
32 days
Submission Type
Summary

Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K233434
510(k) Type
Special
Applicant
Prismatik Dentalcraft, Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/14/2023
Days to Decision
32 days
Submission Type
Summary