FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ANALYTIC TECH. METAL POINT HEATER #3001
K Number: K801974
·
Decision Nov 12, 1980
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
3
Applicant Total
9
Review Days
85
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Basic Information
- Device Name
- ANALYTIC TECH. METAL POINT HEATER #3001
- K Number
- K801974
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Analytic Technology
- Date Received
- August 19, 1980
- Decision Date
- November 12, 1980
- Product Code
- ELA
- 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 |
|---|---|---|---|
| ELA | Instrument, Hand, Calculus Removal | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ELA), ordered by most recent decision date.
OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034)
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TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES
FDA 510(k)
FDA Class 1
·Dental
DENTAL INSTRUMENTS - CUTTING INSTRUMENT
FDA 510(k)
FDA Class 1
·Dental
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 |
| K820598 | HOT & COLD PULP TESTER #4001 | Mar 19, 1982 | Substantially Equivalent |
| K790799 | PULPTESTER MODEL 2001 | May 31, 1979 | Substantially Equivalent |