FDA 510(k) clearance · back to tracker
Digital X-Ray DentiMax Pro Imaging System
Dentimax, Inc. cleared K251206 on 2025-09-24, decision: substantially equivalent
K-number
K251206
Sponsor
Dentimax, Inc.
Device
Digital X-Ray DentiMax Pro Imaging System
Class
Class II
Decision
Substantially Equivalent
Decision date
2025-09-24
Product code
MUH
Advisory committee
Dental
Medical specialty
Dental
Regulation number
872.1800
Official FDA record
Open K251206on accessdata.fda.gov →
FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.
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