PROFIL COMPOSITES (PROFIL, PROFIL FLOW)

Material, Tooth Shade, Resin

SILMET LTD.

The following data is part of a premarket notification filed by Silmet Ltd. with the FDA for Profil Composites (profil, Profil Flow).

Pre-market Notification Details

• Device ID: K103190
• 510k Number: K103190
• Device Name: PROFIL COMPOSITES (PROFIL, PROFIL FLOW)
• Classification: Material, Tooth Shade, Resin
• Applicant: SILMET LTD. 12 HASADNA Or Yehuda, IL 60200
• Contact: Moshe Zalsman
• Correspondent: Moshe Zalsman; SILMET LTD. 12 HASADNA Or Yehuda, IL 60200
• Product Code: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-10-28
• Decision Date: 2011-02-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07290015358385	K103190	000
07290015358224	K103190	000
07290015358217	K103190	000
07290015358200	K103190	000
07290015358194	K103190	000
07290015358187	K103190	000
07290015358170	K103190	000
07290015358163	K103190	000
07290015358156	K103190	000
07290015358149	K103190	000
07290015358132	K103190	000
07290015358125	K103190	000
07290015358118	K103190	000
07290015358101	K103190	000
07290015358231	K103190	000
07290015358248	K103190	000
07290015358378	K103190	000
07290015358361	K103190	000
07290015358354	K103190	000
07290015358347	K103190	000
07290015358330	K103190	000
07290015358323	K103190	000
07290015358316	K103190	000
07290015358309	K103190	000
07290015358293	K103190	000
07290015358286	K103190	000
07290015358279	K103190	000
07290015358262	K103190	000
07290015358255	K103190	000
07290015358095	K103190	000
07290015358088	K103190	000
07290015358071	K103190	000
07290012207914	K103190	000
07290012207907	K103190	000
07290012207891	K103190	000
07290012207884	K103190	000
07290012207877	K103190	000
07290012207860	K103190	000
07290012207853	K103190	000
07290012207846	K103190	000
07290012207839	K103190	000
07290012207822	K103190	000
07290012207815	K103190	000
07290012207808	K103190	000
07290012207792	K103190	000
07290012207921	K103190	000
07290012207938	K103190	000
07290015358064	K103190	000
07290015358057	K103190	000
07290015358040	K103190	000
07290015358033	K103190	000
07290015358026	K103190	000
07290015358019	K103190	000
07290015358002	K103190	000
07290012207990	K103190	000
07290012207983	K103190	000
07290012207976	K103190	000
07290012207969	K103190	000
07290012207952	K103190	000
07290012207945	K103190	000
07290012207785	K103190	000
07290016787825	K103190	000
07290016787504	K103190	000
07290016787498	K103190	000
07290015358828	K103190	000
07290015358811	K103190	000
07290015358804	K103190	000
07290015358798	K103190	000
07290015358781	K103190	000
07290015358774	K103190	000
07290015358767	K103190	000
07290015358750	K103190	000
07290015358743	K103190	000
07290015358736	K103190	000
07290015358729	K103190	000
07290016787511	K103190	000
07290016787528	K103190	000
07290016787740	K103190	000
07290016787726	K103190	000
07290016787719	K103190	000
07290016787702	K103190	000
07290016787696	K103190	000
07290016787689	K103190	000
07290016787672	K103190	000
07290016787665	K103190	000
07290016787641	K103190	000
07290016787566	K103190	000
07290016787559	K103190	000
07290016787542	K103190	000
07290016787535	K103190	000
07290015358712	K103190	000
07290015358705	K103190	000
07290015358699	K103190	000
07290015358538	K103190	000
07290015358521	K103190	000
07290015358514	K103190	000
07290015358507	K103190	000
07290015358491	K103190	000
07290015358484	K103190	000
07290015358477	K103190	000
07290015358460	K103190	000
07290015358453	K103190	000
07290015358446	K103190	000
07290015358439	K103190	000
07290015358422	K103190	000
07290015358408	K103190	000
07290015358545	K103190	000
07290015358552	K103190	000
07290015358682	K103190	000
07290015358675	K103190	000
07290015358668	K103190	000
07290015358651	K103190	000
07290015358644	K103190	000
07290015358637	K103190	000
07290015358620	K103190	000
07290015358613	K103190	000
07290015358606	K103190	000
07290015358590	K103190	000
07290015358583	K103190	000
07290015358576	K103190	000
07290015358569	K103190	000
07290015358392	K103190	000