Angled Screwdriver MED (M-SD090)
FDA 510(k) K253655 · W&H Dentalwerk Bürmoos GmbH
510(k) numberK253655
Submission
- Device name
- Angled Screwdriver MED (M-SD090)
- Applicant
- W&H Dentalwerk Bürmoos GmbH
Buermoos, AT - Received
- November 20, 2025
- Decision date
- July 31, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 510(k) | Device | Decision |
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| K242179 | Synea Fusion Handpieces (Intensiv & Profin)EFB · Traditional | 02/28/2025SE |
Questions and answers
When was Angled Screwdriver MED (M-SD090) cleared by the FDA?
Angled Screwdriver MED (M-SD090) (K253655) received a 510(k) decision of Substantially Equivalent on July 31, 2026, 253 days after the submission was received.
What is the product code of K253655?
The FDA product code is DZI – Drill, Bone, Powered, a Class II (moderate risk) device regulated under 21 CFR 872.4120.