FDA 510(k), K163689, 3M Clear Tray Aligner

FDA 510(k), K163689, 3M Clear Tray Aligner

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510(K) Number: K163689
Device Name: 3M Clear Tray Aligner
Manufacturer: 3M Unitek Corporation
Device Classification Name: aligner, sequential
Regulation Number: 872.5470
Classification Product Code: NXC
Date Received: 12/28/2016
Decision Date: 01/27/2017
Regulation Medical Specialty: Dental

Total pages: 1,250
Fully redacted pages: 1,074
Content pages: 176

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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