{"product_id":"fda-510k-k181331-juvora-oyster-white-dental-disc-ceramill-peek-by-juvora-oyster","title":"FDA 510(k) K181331, JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White, by Juvora, Ltd.","description":"\u003cp\u003eFDA 510(k) records for \u003cstrong\u003eJUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White\u003c\/strong\u003e (K181331), submitted by Juvora, Ltd..\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003e510(k) Number:\u003c\/strong\u003e K181331\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDevice Classification:\u003c\/strong\u003e Resin, Denture, Relining, Repairing, Rebasing\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Juvora, Ltd.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDate Received:\u003c\/strong\u003e 05\/21\/2018\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 12\/21\/2018\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRegulation Number:\u003c\/strong\u003e 872.376\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eProduct Code:\u003c\/strong\u003e EBI\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRegulation Medical Specialty:\u003c\/strong\u003e Dental\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eReview Panel:\u003c\/strong\u003e Dental\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eTotal Pages:\u003c\/strong\u003e 919 (276 unredacted, 69% redacted overall)\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003cstrong\u003eWhat's in this document\u003c\/strong\u003e (sections may appear in any order):\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003e~ \u003cstrong\u003e510(k) Summary \/ Statement:\u003c\/strong\u003e 50% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eIndications for Use:\u003c\/strong\u003e 41% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eDevice Description:\u003c\/strong\u003e 40% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eSubstantial Equivalence \/ Predicate:\u003c\/strong\u003e 40% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003ePerformance \/ Bench Testing:\u003c\/strong\u003e 73% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eBiocompatibility:\u003c\/strong\u003e 66% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eSoftware \/ Cybersecurity:\u003c\/strong\u003e 100% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eSterilization \/ Shelf Life:\u003c\/strong\u003e 50% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eLabeling \/ IFU:\u003c\/strong\u003e 44% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eClinical Data:\u003c\/strong\u003e 100% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eFDA Correspondence:\u003c\/strong\u003e 40% redacted\u003c\/li\u003e\n\u003cli\u003e✓ \u003cstrong\u003eRisk Analysis \/ FMEA:\u003c\/strong\u003e 0% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eElectromagnetic Compatibility (EMC):\u003c\/strong\u003e 60% redacted\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003cem\u003eSection contents and redaction percentages are AI-assisted estimates based on automated document analysis. Actual content may vary.\u003c\/em\u003e\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":53852132966564,"sku":"FDA510K181331","price":895.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda-510k-k181331-juvora-oyster-white-dental-disc-ceramill-peek-by-juvora-oyster.png?v=1791745548","url":"https:\/\/foiadocs.com\/products\/fda-510k-k181331-juvora-oyster-white-dental-disc-ceramill-peek-by-juvora-oyster","provider":"FOIA Document Source","version":"1.0","type":"link"}