Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name retainer, matrix
510(k) Number K091533
Device Name SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200
Applicant
GARRISON DENTAL SOLUTIONS
80 SHELTON TECHNOLOGY CENTER
SHELTON,  CT  06484
Applicant Contact JOSEPH AZARY
Correspondent
GARRISON DENTAL SOLUTIONS
80 SHELTON TECHNOLOGY CENTER
SHELTON,  CT  06484
Correspondent Contact JOSEPH AZARY
Regulation Number872.4565
Classification Product Code
JEP  
Date Received05/26/2009
Decision Date 08/17/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-