08/10/2026
๐๐น๐ฒ๐ฎ๐ฟ๐ฒ๐ฑ ๐ถ๐ ๐ป๐ผ๐ ๐๐ต๐ฒ ๐๐ฎ๐บ๐ฒ ๐ฎ๐ ๐ฝ๐ฟ๐ผ๐๐ฒ๐ป โ ๐ฎ๐ป๐ฑ ๐๐ต๐ฒ๐ฟ๐ฒ'๐ ๐ฎ ๐ฝ๐๐ฏ๐น๐ถ๐ฐ ๐๐ฒ๐ฎ๐ฟ๐ฐ๐ต ๐ฏ๐ผ๐
๐๐ต๐ฎ๐ ๐๐ต๐ผ๐๐ ๐๐ผ๐ ๐๐ต๐ฒ ๐ฑ๐ถ๐ณ๐ณ๐ฒ๐ฟ๐ฒ๐ป๐ฐ๐ฒ.
In dentistry, radiographic AI is regulated: it's a Class II device because it makes a claim about pathology. Crown design, voice charting, scheduling, chatbots โ largely unregulated. Often excellent, but nobody independent has checked.
Clearance is also narrow. Cleared to find caries on bitewings means exactly that, and nothing else.
Ask your vendor which 510(k) number their product was cleared under. Friendly question, correct answer, public record.