FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NL
K Number: K991021
·
Decision Jun 23, 1999
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
194
Applicant Total
13
Review Days
86
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Basic Information
- Device Name
- SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NL
- K Number
- K991021
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4850
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Nsk Nakanishi, Inc.
- Date Received
- March 29, 1999
- Decision Date
- June 23, 1999
- Product Code
- ELC
- 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 |
|---|---|---|---|
| ELC | Scaler, Ultrasonic | FDA class 2 | Dental |
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FDA 510(k)
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