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510(k) Data Aggregation
K Number
K012744Device Name
INTRAORAL LENS OPTION TO SPECTROSHADE
Manufacturer
Date Cleared
2002-01-23
(160 days)
Product Code
Regulation Number
872.6640Why did this record match?
Applicant Name (Manufacturer) :
MHT OPTIC RESEARCH AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
SpectroShade's intraoral lens option is an accessory imaging device, which is intended for use by dental professionals in taking intraoral images of dental anatomy in order to:
- 1) Assist in the assessment of the overall patient's dental health by providing magnified digital images of the oral cavity.
- 2) Provide visual educational information to the patient to more effectively communicate a treatment plan.
- 3) Provide documented images for patient records, insurance companies, and other dental professionals.
- 4) Allow the practitioner to display before and after images of dental procedures.
Device Description
Intraoral Lens Option To SpectroShade
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