{"product_id":"fda-510k-k190043","title":"FDA 510(k) K190043, Halley resin, by Dentsply Sirona","description":"\u003cp\u003e\n\u003cstrong\u003eDevice Classification Name: \u003c\/strong\u003eResin, Denture, Relining, Repairing, Rebasing\u003cbr\u003e\n\u003cstrong\u003e510(k) Number: \u003c\/strong\u003eK190043\u003cbr\u003e\n\u003cstrong\u003eDevice Name:\u003c\/strong\u003e Halley resin\u003cbr\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Dentsply Sirona\u003cbr\u003e\n\u003cstrong\u003eRegulation Number: \u003c\/strong\u003e872.376\u003cbr\u003e\n\u003cstrong\u003eClassification Product Code: \u003c\/strong\u003eEBI\u003cbr\u003e\n\u003cstrong\u003eDate Received: \u003c\/strong\u003e2019-01-09\u003cbr\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 2019-04-24\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 664\u003cbr\u003e\n\u003cstrong\u003eFully redacted pages:\u003c\/strong\u003e 405\u003cbr\u003e\n\u003cstrong\u003eContent pages:\u003c\/strong\u003e 259\n\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51309545062564,"sku":"FDA510K190043","price":804.6,"currency_code":"USD","in_stock":true}],"url":"https:\/\/foiadocs.com\/products\/fda-510k-k190043","provider":"FOIA Document Source","version":"1.0","type":"link"}