FDA 510(k) K253206: METICULY Patient-specific CMF solution
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
Dental implant and oral-surgery practices now have another FDA-cleared, patient-specific CMF plate option for complex facial reconstructions; owners and specialists should evaluate cost, lead time, and reimbursement differences versus stock plates.
Key points
- Device cleared via traditional 510(k) K253206 as substantially equivalent (Class II, product code JEY, Reg. 872.4760).
- Meticuly’s plates are custom-fabricated for individual cranio-maxillofacial defects, targeting oral surgeons and plastic-reconstructive teams.
- Potential practice impact includes case-by-case pre-authorization, variable reimbursement, and changes in OR scheduling due to production lead times.
- No recall or safety alert attached; routine surveillance for post-market data remains standard.
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.
Related
- ·Business
‘Surviving your own balance sheet’: The operational challenges weighing DSOs down
- ·Regulatory
ADHA opposes Nevada bill allowing hygienists to skip accredited training
- ·Business
23% of dentists have dropped insurers so far in 2026
- ·Business
Dental reimbursement rates not keeping pace with inflation: ADA