FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM
K Number: K100647
·
Decision Jul 9, 2010
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
194
Applicant Total
69
Review Days
123
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Basic Information
- Device Name
- A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM
- K Number
- K100647
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4850
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- A-Dec, Inc.
- Date Received
- March 8, 2010
- Decision Date
- July 9, 2010
- 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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|---|---|---|---|
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