FDA 510(k), K172007, CamX Triton HD Proxi Head

FDA 510(k), K172007, CamX Triton HD Proxi Head

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510(K) Number: K172007
Device Name: CamX Triton HD Proxi Head
Manufacturer: Duerr Dental AG
Device Classification Name: Caries Detector, Laser Light, Transmission
Regulation Number: 872.1745
Classification Product Code: NTK
Date Received: 07/03/2017
Decision Date: 11/22/2017
Regulation Medical Specialty: Dental

254 pages (649 of 903 original pages are fully redacted)

PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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