FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
DENTAL ULTRASONIC SCALER/ENDOSONIC
K Number: K840141
·
Decision Mar 16, 1984
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
194
Applicant Total
97
Review Days
71
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Basic Information
- Device Name
- DENTAL ULTRASONIC SCALER/ENDOSONIC
- K Number
- K840141
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4850
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- CooperVision, Inc.
- Date Received
- January 5, 1984
- Decision Date
- March 16, 1984
- 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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| K190965 | MyDay | Apr 29, 2019 | Substantially Equivalent |
| K181920 | Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker | Dec 11, 2018 | Substantially Equivalent |
| K160803 | Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens | Jul 13, 2016 | Substantially Equivalent |
| K133627 | AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS | Dec 23, 2013 | Substantially Equivalent |
| K131378 | SUS (STENFILCON A) CONTACT LENS | Aug 30, 2013 | Substantially Equivalent |