FDA 510(k)
FDA class 1
Substantially Equivalent
🇯🇵 Japan
SURGIC II IMPLANT CONTROL UNIT
K Number: K972924
·
Decision Oct 30, 1997
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
60
Applicant Total
13
Review Days
83
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Basic Information
- Device Name
- SURGIC II IMPLANT CONTROL UNIT
- K Number
- K972924
- 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
- August 8, 1997
- Decision Date
- October 30, 1997
- Product Code
- EBW
- 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 |
|---|---|---|---|
| EBW | Controller, Foot, Handpiece And Cord | FDA class 1 | Dental |
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Other Clearances by Nsk Nakanishi, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| 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 |
| K990682 | PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MAX), ENDO-MATE (600RPM MAX.) | Mar 24, 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 |
| 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 |