Ultradent Products Inc. / K1 11017 Trade / Address Ultradent Products Inc. / /
Country
United States / /
Currency
pence / /
Event
FDA Phase / /
Facility
General Hospital / /
IndustryTerm
medical device / announcements concerning your device / predicate device / manufacturing practice requirements / provisional cement / similar products / cement / marketed predicate devices / manufacturing practice / temporary cement / /
MedicalCondition
Irritation / Ambient Light Sensitivity / /
Organization
Division of Postmarket Surveillance / CDR-1's office of Surveillance / Food and Drug Administration / M.B.A. Director Division of Anesthesiology / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / Infection Control and Dental Devices Office / General Hospital / Device Evaluation Center for Devices and Radiological Health Enclosure Statement of Indications for Use / DEPARTMENT OF HEALTH / /
Person
Silver Spring / Diane Rogers / Anthony D. Watson / / /
Section 5JU[removed]Traditional 5 10(k) Summary This summary of the Traditional 510(k) substantial equivalence information is being submitted in