FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL G-61 ULTRASONIC DENTAL UNIT
K Number: K791585
·
Decision Sep 19, 1979
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
194
Applicant Total
32
Review Days
33
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Basic Information
- Device Name
- MODEL G-61 ULTRASONIC DENTAL UNIT
- K Number
- K791585
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4850
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Cavitron Corp.
- Date Received
- August 17, 1979
- Decision Date
- September 19, 1979
- Product Code
- ELC
- 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 |
|---|---|---|---|
| ELC | Scaler, Ultrasonic | FDA class 2 | Dental |
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Other Clearances by Cavitron Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K811582 | THE PLACER | Jul 28, 1981 | Substantially Equivalent |
| K810207 | MINOR SURGERY LIGHT | Feb 13, 1981 | Substantially Equivalent |
| K802928 | SPIROMETRIC COMPUTER #SC-10 | Dec 17, 1980 | Substantially Equivalent |
| K801623 | CAVITRON ULTRASONIC SURG. ASPIR. CUSA | Nov 18, 1980 | Substantially Equivalent |
| K801877 | SLIT LAMP ATTACHMENT | Sep 16, 1980 | Substantially Equivalent |
| K800869 | MODEL PM-20(N)(R)CO2 PATIENT MONITOR/ALA | May 28, 1980 | Substantially Equivalent |
| K800722 | AUTO-FIELD D AUTOMATED VISUAL DETECTOR | Apr 29, 1980 | Substantially Equivalent |
| K791277 | MODEL 6500 EXTRACTION IRRIGATION SYS | Aug 22, 1979 | Substantially Equivalent |
| K782054 | LASER, CO2 SURGICAL | Jan 17, 1979 | Substantially Equivalent |
| K782065 | LASER, PHOTOCOAGULATION | Dec 28, 1978 | Substantially Equivalent |