FDA 510(k) K253655: Angled Screwdriver MED (M-SD090)
Summary & scoring by The Bell Brief (Dr. Jennifer Bell) using the Drill-Down Protocol (Drill-Down Score) — not the original publisher.
Why it matters for dental
The new angled screwdriver clearance gives general dentists and oral surgeons a powered option for tight-access implant osteotomies, potentially reducing the need for flap elevation or second-stage surgery in posterior sites.
Key points
- Device cleared under K253655 for W&H Dentalwerk Bürmoos GmbH; product code DZI, Class II, regulation 872.4120.
- Traditional 510(k) pathway; labeled 'substantially equivalent' to predicate devices rather than novel technology.
- Powered bone drill indicated for angled access—useful for single-unit and short-span implant cases where straight-line drilling is obstructed.
- No recall history or special controls cited; clinics should verify compatibility with existing W&H motor systems before stocking.
Who should care
Read the original on openFDA Dental Devices
Full reporting and any paywall content live on accessdata.fda.gov. We summarize and score; we do not republish.
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