FDA 510(k)
FDA class 1
Substantially Equivalent
🇯🇵 Japan
E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION
K Number: K972569
·
Decision Oct 8, 1997
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
72
Applicant Total
13
Review Days
90
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Basic Information
- Device Name
- E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION
- K Number
- K972569
- 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
- July 10, 1997
- Decision Date
- October 8, 1997
- Product Code
- EGS
- 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 |
|---|---|---|---|
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | FDA class 1 | Dental |
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| K972924 | SURGIC II IMPLANT CONTROL UNIT | Oct 30, 1997 | Substantially Equivalent |
| K971774 | NSK PUSH-BUTTON MIDWEST REPLACEMENT TURBINE:FOR QUIETAIR AND TRADITION | Jun 20, 1997 | Substantially Equivalent |
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| K962542 | AIR MOTOR HANDPIECE TN-102 | Sep 24, 1996 | Substantially Equivalent |