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 | Device Class | Medical Specialty |
|---|---|---|---|
| EAT | Tester, Pulp | FDA class 2 | Dental |
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Other Clearances by Analytic Technology
| K Number | Device Name | ||
|---|---|---|---|
| K921604 | TOUCH N' HEAT, MODIFICATION | Aug 24, 1992 | Substantially Equivalent |
| K915243 | TOUCH 'N HEAT MODEL 5002, MODIFICATION | Jan 21, 1992 | Substantially Equivalent |
| K890735 | COATED APEX PROBE | Apr 19, 1989 | Substantially Equivalent |
| K864500 | ANALYTIC TECHNOLOGY ENDO ANALYZER MODEL 8001 | Mar 19, 1987 | Substantially Equivalent |
| K832179 | HOT PROBE MODEL 6001 | Oct 4, 1983 | Substantially Equivalent |
| K823486 | TOUCH-N-HEAT MODEL 5001 | Jan 18, 1983 | Substantially Equivalent |
| K801974 | ANALYTIC TECH. METAL POINT HEATER #3001 | Nov 12, 1980 | Substantially Equivalent |
| K790799 | PULPTESTER MODEL 2001 | May 31, 1979 | Substantially Equivalent |