FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYGIENTIST; CYCLOSON I & II; RETROFIT
K Number: K812909
·
Decision Dec 14, 1981
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
194
Applicant Total
10
Review Days
56
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Basic Information
- Device Name
- HYGIENTIST; CYCLOSON I & II; RETROFIT
- K Number
- K812909
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4850
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Fibra Sonics, Inc.
- Date Received
- October 19, 1981
- Decision Date
- December 14, 1981
- 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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FDA 510(k)
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Other Clearances by Fibra Sonics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K993046 | FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000 | Nov 22, 1999 | Substantially Equivalent |
| K984199 | EXONIX | Feb 17, 1999 | Substantially Equivalent |
| K984143 | FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM | Feb 16, 1999 | Substantially Equivalent |
| K983199 | FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODEL | Dec 14, 1998 | Substantially Equivalent |
| K980930 | FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA | Sep 22, 1998 | Substantially Equivalent |
| K842024 | ULTRASONIC LITHOTRIPTOR 300A | Dec 11, 1984 | Substantially Equivalent |
| K834453 | PHACO FRAGMENTOR GT-1 | Mar 16, 1984 | Substantially Equivalent |
| K813389 | ULTRASONIC FRAGMENTOR | Feb 4, 1982 | Substantially Equivalent |
| K802381 | LEWICKY ANTERIOR CHAMBER MAINTEN. SYS. | Dec 17, 1980 | Substantially Equivalent |