FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TURBINE, AIR DRIVEN HANDPIECE (2000)
K Number: K760331
·
Decision Aug 11, 1976
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
260
Applicant Total
12
Review Days
14
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Basic Information
- Device Name
- TURBINE, AIR DRIVEN HANDPIECE (2000)
- K Number
- K760331
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Litton Dental Products
- Date Received
- July 28, 1976
- Decision Date
- August 11, 1976
- Product Code
- EFB
- 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 |
|---|---|---|---|
| EFB | Handpiece, Air-Powered, Dental | FDA class 1 | Dental |
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Other Clearances by Litton Dental Products
| K Number | Device Name | ||
|---|---|---|---|
| K791704 | MASTERSCALE II | Oct 26, 1979 | Substantially Equivalent |
| K791024 | ULTRASONIC DENTAL PROPHYLAXIS UNIT | Sep 17, 1979 | Substantially Equivalent |
| K781114 | ULTRAMATE 990 | Aug 14, 1978 | Substantially Equivalent |
| K781044 | ULTRASONIC DENTAL PROPHYLAXIS UNIT,SSM | Jun 30, 1978 | Substantially Equivalent |
| K772244 | ILLUMINATED DENTAL HANDPIECE | Jan 20, 1978 | Substantially Equivalent |
| K771556 | EXR | Aug 22, 1977 | Substantially Equivalent |
| K771557 | ULTRASON 990 | Aug 19, 1977 | Substantially Equivalent |
| K771251 | HU:500, HYGIENASSIST | Jul 15, 1977 | Substantially Equivalent |
| K771252 | CB600, TURBINE CONTROL BOL | Jul 15, 1977 | Substantially Equivalent |
| K761246 | SONUS III | Dec 16, 1976 | Substantially Equivalent |