FDA 510(k) K251544: Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)
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
This standard 510(k) clearance for Lakong Medical Devices' operative dental units (MP2000-550LED-2.0, LP2100-550LED-2.0) adds two more Class I chairside units to the U.S. market—routine news for owners evaluating equipment budgets, not an immediate compliance or revenue issue.
Key points
- Device class 1, product code EIA under 21 CFR 872.6640—lowest regulatory burden; no pre-market clinical data required.
- Clearance based on substantial equivalence to existing predicate devices, not new technology or clinical claims.
- Practice owners and DSO procurement teams can now request quotes on these LED-equipped units alongside existing brands.
- No recall history or safety alerts attached; standard post-market surveillance applies.
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
Why the dental assistant shortage could get worse
- ·Business
US Oral Surgery Management exec on M&A: ‘We’ve had to be even more disciplined’
- ·Research
Vertical dimension of occlusion restoration using a digital injectable composite resin technique: A 5-year clinical follow-up
- ·Research
A digitally guided workflow integrating tooth preparation and restoration positioning for minimally invasive veneer and partial-coverage restorations: A dental technique