Bisco Inc. / K131357 Trade / Ultradent Products Inc. / Address SP0 11 Ultradent Products Inc. / /
Country
United States / /
Facility
General Hospital / New HaImpshire Avenue Document Control Center / /
IndustryTerm
medical device / metals/metal alloys / announcements concerning your device / predicate device / chemical bond / manufacturing practice requirements / predicate product / metal/alloys / similar products / metal/metal alloys / marketed predicate devices / manufacturing practice / /
MedicalCondition
Irritation / /
Organization
Division of Postmarket Surveillance / HUMAN SERVICES IS Public Healib Service / New HaImpshire Avenue Document Control Center / office of Device Evaluation / office of Surveillance / FDA / General Hospital / Device Evaluation Center for Devices and Radiological Health Enclosure Statement of Indications for Use / Respiratory / Infection Control and Dental Devices Office / Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / /
Person
Diane Rogers / Kwame Ulmer / / /
Position
dentist / Resin Tooth Bonding Agent / Manager of Regulatory and Globel Affairs / PeakZ Resin tooth bonding agent / Manager of Regulatory and Global Affairs / /
fCV3[removed]Section 5 Traditional 510(k) Summary This summary of the Traditional S1O(k) substantial equivalence information isbeing submitted in accordance with the requirements of 21 CFR[removed].