FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HOT PROBE MODEL 6001
K Number: K832179
·
Decision Oct 4, 1983
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
11
Applicant Total
9
Review Days
90
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Basic Information
- Device Name
- HOT PROBE MODEL 6001
- K Number
- K832179
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6475
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Analytic Technology
- Date Received
- July 6, 1983
- Decision Date
- October 4, 1983
- Product Code
- EEG
- 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 |
|---|---|---|---|
| EEG | Heat Source For Bleaching Teeth | FDA class 1 | 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 |
| K823486 | TOUCH-N-HEAT MODEL 5001 | Jan 18, 1983 | Substantially Equivalent |
| K820598 | HOT & COLD PULP TESTER #4001 | Mar 19, 1982 | Substantially Equivalent |
| K801974 | ANALYTIC TECH. METAL POINT HEATER #3001 | Nov 12, 1980 | Substantially Equivalent |
| K790799 | PULPTESTER MODEL 2001 | May 31, 1979 | Substantially Equivalent |