Tester, Pulp

Device Code: 1113

Product Code(s): EAT

Device Classification Information

Device Type ID1113
Device NameTester, Pulp
Regulation DescriptionPulp Tester.
Regulation Medical SpecialtyDental
Review PanelDental
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Dental Devices Branch (DEDB)
Submission Type510(K) Exempt
CFR Regulation Number872.1720 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeEAT
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID1113
DeviceTester, Pulp
Product CodeEAT
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionPulp Tester.
CFR Regulation Number872.1720 [🔎]
TPLC Last Update: 2019-04-02 19:48:33

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.