FDA 510(k)
FDA class 1
Substantially Equivalent
🇯🇵 Japan
MACH-SIGMA HANDPIECE, ULTRAPUSH, MODELS MACH-SIGMA MU (MINI HEAD), MACH-SIGMA SU (STD. HEAD), MACH-SIGMA TU (TORQUE HD)
K Number: K991701
·
Decision Aug 10, 1999
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
260
Applicant Total
13
Review Days
83
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Basic Information
- Device Name
- MACH-SIGMA HANDPIECE, ULTRAPUSH, MODELS MACH-SIGMA MU (MINI HEAD), MACH-SIGMA SU (STD. HEAD), MACH-SIGMA TU (TORQUE HD)
- K Number
- K991701
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Nsk Nakanishi, Inc.
- Date Received
- May 19, 1999
- Decision Date
- August 10, 1999
- 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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| K Number | Device Name | ||
|---|---|---|---|
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| K980162 | MACH-SIGMA HANDPIECE, ULTRAPUSH | Jun 5, 1998 | Substantially Equivalent |
| K972924 | SURGIC II IMPLANT CONTROL UNIT | Oct 30, 1997 | Substantially Equivalent |
| K972569 | E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION | Oct 8, 1997 | Substantially Equivalent |
| K971774 | NSK PUSH-BUTTON MIDWEST REPLACEMENT TURBINE:FOR QUIETAIR AND TRADITION | Jun 20, 1997 | Substantially Equivalent |
| K970953 | E-TYPE SPEED REDUCER CONTRA ANGLE | Apr 15, 1997 | Substantially Equivalent |
| K962542 | AIR MOTOR HANDPIECE TN-102 | Sep 24, 1996 | Substantially Equivalent |