FDA · official record K091533Substantially Equivalent

SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200

Name: SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200 — FDA K091533
Creator: Garrison Dental Solutions
Keywords: SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200, SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200, K091533, JEP, FDA

United StatesJEPGarrison Dental Solutions

Verified

Official record identity

FDA application number: K091533
Decision date: August 17, 2009
Published decision: Substantially Equivalent

Classification

Product code: JEP

Published parties

Applicant: Garrison Dental Solutions

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2009-05-26
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.4565

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.