{"product_id":"fda-510k-k152113-biohpp-brecambiohpp","title":"FDA 510(k) K152113, BioHPP - breCAM.BioHPP, by Bredent GmbH \u0026 Co. KG","description":"\u003cp\u003eFDA 510(k) records for \u003cstrong\u003eBioHPP - breCAM.BioHPP\u003c\/strong\u003e (K152113), submitted by Bredent GmbH \u0026amp; Co. KG.\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003e510(k) Number:\u003c\/strong\u003e K152113\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDevice Classification:\u003c\/strong\u003e Material, Tooth Shade, Resin\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Bredent GmbH \u0026amp; Co. KG\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDate Received:\u003c\/strong\u003e 07\/29\/2015\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 07\/21\/2016\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 872.369\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eProduct Code:\u003c\/strong\u003e EBF\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSubsequent Product 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 434 (182 unredacted, 58% 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 40% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eDevice Description:\u003c\/strong\u003e 63% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eSubstantial Equivalence \/ Predicate:\u003c\/strong\u003e 57% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003ePerformance \/ Bench Testing:\u003c\/strong\u003e 70% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eBiocompatibility:\u003c\/strong\u003e 56% 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 66% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eLabeling \/ IFU:\u003c\/strong\u003e 55% 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 21% redacted\u003c\/li\u003e\n\u003cli\u003e~ \u003cstrong\u003eRisk Analysis \/ FMEA:\u003c\/strong\u003e 54% redacted\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eElectromagnetic Compatibility (EMC):\u003c\/strong\u003e 77% 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":53852132507812,"sku":"FDA510K152113","price":299.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda-510k-k152113-biohpp-brecambiohpp.png?v=1791745895","url":"https:\/\/foiadocs.com\/products\/fda-510k-k152113-biohpp-brecambiohpp","provider":"FOIA Document Source","version":"1.0","type":"link"}