FDA 510(k), K893396, AN ALTERNATIVE DIRECT BONDING ORTHO. SYSTEM

FDA 510(k), K893396, AN ALTERNATIVE DIRECT BONDING ORTHO. SYSTEM

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510(K) Number: K893396
Device Name: AN ALTERNATIVE DIRECT BONDING ORTHO. SYSTEM
Manufacturer:
Device Classification Name: Adhesive, Bracket And Tooth Conditioner, Resin
Regulation Number: 872.3750
Classification Product Code: DYH
Date Received: 05/01/1989
Decision Date: 06/23/1989
Regulation Medical Specialty: Dental

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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