FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

HOT & COLD PULP TESTER #4001

K Number: K820598 · Decision Mar 19, 1982
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
21
Applicant Total
9
Review Days
15

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Basic Information

Device Name
HOT & COLD PULP TESTER #4001
K Number
K820598
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
872.1720
Medical Specialty
Dental
Decision
Substantially Equivalent
Applicant
Analytic Technology
Date Received
March 4, 1982
Decision Date
March 19, 1982
Product Code
EAT
Advisory Committee
Dental
Review Advisory Committee
DE
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
EAT Tester, Pulp

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K864500 ANALYTIC TECHNOLOGY ENDO ANALYZER MODEL 8001
K832179 HOT PROBE MODEL 6001
K823486 TOUCH-N-HEAT MODEL 5001
K801974 ANALYTIC TECH. METAL POINT HEATER #3001
K790799 PULPTESTER MODEL 2001