FDA 510(k), K172765, Smart Moves Complete

FDA 510(k), K172765, Smart Moves Complete

Regular price $655.09 USD
Regular price Sale price $655.09 USD
Sale Sold out

510(K) Number: K172765
Device Name: Smart Moves Complete
Manufacturer: Great Lakes Orthodontics Ltd
Device Classification Name: Aligner, Sequential
Regulation Number: 872.5470
Classification Product Code: NXC
Date Received: 09/13/2017
Decision Date: 06/01/2018
Regulation Medical Specialty: Dental

282 pages (569 of 851 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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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.

View full details