FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇹 Austria
Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)
K Number: K243280
·
Decision Jul 3, 2025
Classifications
1
FEI Numbers
125
Registration Numbers
125
Same Product Code
90
Applicant Total
3
Review Days
259
Basic Information
- Device Name
- Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)
- K Number
- K243280
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4250
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- W&H Dentalwerk Buermoos GmbH
- Date Received
- October 17, 2024
- Decision Date
- July 3, 2025
- Product Code
- ERL
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | FDA class 2 | Ear, Nose, Throat |
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