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ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K974906
510(k) Type
Traditional
Applicant
COLTENE/WHALEDENT INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/24/1998
Days to Decision
83 days
Submission Type
Statement

ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K974906
510(k) Type
Traditional
Applicant
COLTENE/WHALEDENT INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/24/1998
Days to Decision
83 days
Submission Type
Statement