Last synced on 27 June 2025 at 11:06 pm

A&E ZIRCONIA BLANKS MODEL EZBUCT02, EZBUCT04, EZBUCT25, EZBUCT31, EZBUST07, EZBUST08, EZBUTT05, EZBUTT06

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K100145
510(k) Type
Abbreviated
Applicant
A&E BIOCERAMIC CO., LTD.
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
4/13/2010
Days to Decision
84 days
Submission Type
Statement

A&E ZIRCONIA BLANKS MODEL EZBUCT02, EZBUCT04, EZBUCT25, EZBUCT31, EZBUST07, EZBUST08, EZBUTT05, EZBUTT06

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K100145
510(k) Type
Abbreviated
Applicant
A&E BIOCERAMIC CO., LTD.
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
4/13/2010
Days to Decision
84 days
Submission Type
Statement