FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
tün® ultrasonic tips product family
K Number: K182145
·
Decision Jun 7, 2019
Classifications
1
FEI Numbers
104
Registration Numbers
104
Same Product Code
191
Applicant Total
1
Review Days
303
Basic Information
- Device Name
- tün® ultrasonic tips product family
- K Number
- K182145
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4850
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Engineered Endodontics
- Date Received
- August 8, 2018
- Decision Date
- June 7, 2019
- 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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