FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 HOLES, MODELS HS 2012 (STANDARD HEAD) & HS 2014 (SMALL HEAD)
K Number: K021250
·
Decision Oct 24, 2002
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
1
Review Days
188
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Basic Information
- Device Name
- MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 HOLES, MODELS HS 2012 (STANDARD HEAD) & HS 2014 (SMALL HEAD)
- K Number
- K021250
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Handpiece Unlimited
- Date Received
- April 19, 2002
- Decision Date
- October 24, 2002
- Product Code
- EBF
- 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | FDA class 2 | Dental |
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