{"product_id":"fda-510k-k230199","title":"FDA 510(k) K230199, Byte Aligner System, by Dentsply Sirona, Inc.","description":"\u003cp\u003e\n\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eAligner, Sequential\u003cbr\u003e\n\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK230199\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e Byte Aligner System\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Dentsply Sirona, Inc.\u003cbr\u003e\n\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e872.5470\u003cbr\u003e\n\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003eNXC\u003cbr\u003e\n\u003cstrong\u003eDate Received: \u003c\/strong\u003e01\/25\/2023\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 10\/18\/2023\u003cbr\u003e\n\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003cbr\u003e\n\u003cstrong\u003eRegulation Medical Specialty: \u003c\/strong\u003eDental\u003cbr\u003e\n\u003cstrong\u003e510k Review Panel: \u003c\/strong\u003eDental\u003cbr\u003e\n\u003c\/p\u003e\n\u003cp\u003e\n\u003cstrong\u003eTotal number of pages:\u003c\/strong\u003e 974\u003cbr\u003e\n\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 408\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 566\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51313334386852,"sku":"FDA510K230199","price":1426.66,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k230199","provider":"FOIA Document Source","version":"1.0","type":"link"}