BACKGROUNDRegulatoryTier 1
FDA 510(k) K262433: OrthoFit Aligner (OrthoFit Aligner A2)
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
OrthoFit Aligner A2 receives FDA 510(k) clearance, allowing U.S. practices to evaluate a new resin-based bracket and tooth conditioner adhesive under Class II rules.
Key points
- Spident Co., Ltd. submitted and received clearance for the OrthoFit Aligner A2.
- FDA classified the device as substantially equivalent via traditional 510(k) pathway.
- Product code DYH and Regulation 872.3750 govern this adhesive, bracket, and tooth conditioner resin.
- Device class remains Class 2 under FDA dental-device oversight.
Who should care
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