FDA 510(k)
FDA class 1
Substantially Equivalent
🇯🇵 Japan
PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.)
K Number: K990682
·
Decision Mar 24, 1999
Classifications
1
FEI Numbers
88
Registration Numbers
88
Same Product Code
88
Applicant Total
13
Review Days
21
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Basic Information
- Device Name
- PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.)
- K Number
- K990682
- 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
- March 3, 1999
- Decision Date
- March 24, 1999
- Product Code
- EKX
- 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 |
|---|---|---|---|
| EKX | Handpiece, Direct Drive, Ac-Powered | FDA class 1 | Dental |
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Other Clearances by Nsk Nakanishi, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K991701 | MACH-SIGMA HANDPIECE, ULTRAPUSH, MODELS MACH-SIGMA MU (MINI HEAD), MACH-SIGMA SU (STD. HEAD), MACH-SIGMA TU (TORQUE HD) | Aug 10, 1999 | Substantially Equivalent |
| K991021 | SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NL | Jun 23, 1999 | Substantially Equivalent |
| K990954 | ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET | Jun 9, 1999 | Substantially Equivalent |
| K990646 | PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE | Mar 19, 1999 | Substantially Equivalent |
| 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 |