Home / 510(k) Clearances / K253655

510(k) K253655

Angled Screwdriver MED (M-SD090) by W&H Dentalwerk Bürmoos GmbH — Product Code DZI

K253655 is an FDA 510(k) premarket notification submitted by W&H Dentalwerk Bürmoos GmbH for the device "Angled Screwdriver MED (M-SD090)". The FDA issued a decision of Substantially Equivalent on July 31, 2026. The device falls under product code DZI (Drill, Bone, Powered), a Class II device regulated under 21 CFR 872.4120. W&H Dentalwerk Bürmoos GmbH has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2026
Date Received
November 20, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drill, Bone, Powered
Device Class
Class II
Regulation Number
872.4120
Review Panel
DE
Submission Type

Other clearances by W&H Dentalwerk Bürmoos GmbH

  • K242179 — Synea Fusion Handpieces (Intensiv & Profin) (February 28, 2025)

Other clearances for product code DZI

  • K253776 — Implantmed Plus II & Piezomed Plus II Module (June 18, 2026)
  • K254163 — VarioSurg 4 (December 23, 2025)
  • K242432 — MT-Bone (August 19, 2024)
  • K240340 — Surgical Drive System (Model: ES70, ES90, E8) (July 18, 2024)
  • K231087 — Guided Surgery Kit (August 16, 2023)
  • K192561 — TRAUS SUS20 (July 13, 2020)
  • K200265 — Surgical Drills (June 30, 2020)
  • K192033 — Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-In (June 9, 2020)
  • K172137 — PIEZOTOME CUBE (May 3, 2018)
  • K171326 — Piezosurgery White (April 13, 2018)

FDA data resources