Pure Global AI
FDA · official record K914697Substantially Equivalent

MDT/CASTLE PURUS DENTAL UNIT

United StatesEIAMdt Corp., Inc.
Official record identity
FDA application number
K914697
Decision date
November 13, 1991
Published decision
Substantially Equivalent
Classification
Published parties
Additional source fields
Decision code
SESE
Published decision
Substantially Equivalent
Submission type
Traditional
Received date
1991-10-18
Review panel
Dental
Current product-code class (harmonized)
1
Current product-code regulation (harmonized)
872.6640
About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.