ENA HFO COMPOSITE SYSTEM

Material, Tooth Shade, Resin

MICERIUM S.P.A.

The following data is part of a premarket notification filed by Micerium S.p.a. with the FDA for Ena Hfo Composite System.

Pre-market Notification Details

• Device ID: K062906
• 510k Number: K062906
• Device Name: ENA HFO COMPOSITE SYSTEM
• Classification: Material, Tooth Shade, Resin
• Applicant: MICERIUM S.P.A. VIA MARCONI 83 Avengo, IT 16030
• Contact: Eugenio Miceli
• Correspondent: Eugenio Miceli; MICERIUM S.P.A. VIA MARCONI 83 Avengo, IT 16030
• Product Code: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-09-27
• Decision Date: 2006-11-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
EMICEHFS0	K062906	000
EMICEHR6FC0	K062906	000
EMICEHR6FC1	K062906	000
EMICEHRBD00	K062906	000
EMICEHRBD01	K062906	000
EMICEHRBD050	K062906	000
EMICEHRBD051	K062906	000
EMICEHRBD10	K062906	000
EMICEHRBD11	K062906	000
EMICEHRBD20	K062906	000
EMICEHRBD21	K062906	000
EMICEHRBD30	K062906	000
EMICEHRBD31	K062906	000
EMICEHRBD350	K062906	000
EMICEHR6B1	K062906	000
EMICEHR6B0	K062906	000
EMICEHFS1	K062906	000
EMICEHOA0	K062906	000
EMICEHOA1	K062906	000
EMICEHOBN0	K062906	000
EMICEHOBN1	K062906	000
EMICEHR150	K062906	000
EMICEHR151	K062906	000
EMICEHR3FC0	K062906	000
EMICEHR3FC1	K062906	000
EMICEHR4F0	K062906	000
EMICEHR4F1	K062906	000
EMICEHR4FC0	K062906	000
EMICEHR4FC1	K062906	000
EMICEHRBD351	K062906	000
EMICEHRBD40	K062906	000
EMICEHREF21	K062906	000
EMICEHREF30	K062906	000
EMICEHREF31	K062906	000
EMICEHRFUD00	K062906	000
EMICEHRFUD01	K062906	000
EMICEHRFUD050	K062906	000
EMICEHRFUD051	K062906	000
EMICEHRFUD10	K062906	000
EMICEHRFUD11	K062906	000
EMICEHRFUD20	K062906	000
EMICEHRFUD21	K062906	000
EMICEHRFUD30	K062906	000
EMICEHRFUD31	K062906	000
EMICEHREF20	K062906	000
EMICEHREF11	K062906	000
EMICEHRBD41	K062906	000
EMICEHRBD50	K062906	000
EMICEHRBD51	K062906	000
EMICEHRBD60	K062906	000
EMICEHRBD61	K062906	000
EMICEHRBF10	K062906	000
EMICEHRBF11	K062906	000
EMICEHRBF20	K062906	000
EMICEHRBF21	K062906	000
EMICEHRBF2F1	K062906	000
EMICEHRBF30	K062906	000
EMICEHRBF31	K062906	000
EMICEHREF10	K062906	000
EMICEHRFUD350	K062906	000
EMICEHF8N1	K062906	000
EMICEH5UB0	K062906	000
EMICEHFUD11	K062906	000
EMICEHFUD20	K062906	000
EMICEHFUD21	K062906	000
EMICEHFUD30	K062906	000
EMICEHFUD31	K062906	000
EMICEHFUD350	K062906	000
EMICEHFUD351	K062906	000
EMICEHFUD40	K062906	000
EMICEHFUD41	K062906	000
EMICEHFUD50	K062906	000
EMICEHFUD51	K062906	000
EMICEHFUD60	K062906	000
EMICEHR3FB1	K062906	000
EMICEHFUD10	K062906	000
EMICEHFB41	K062906	000
EMICEHFGC0	K062906	000
EMICEHFGC1	K062906	000
EMICEHR5UB1	K062906	000
EMICEHTS20	K062906	000
EMICEHTS21	K062906	000
EMICEHTSF0	K062906	000
EMICEHTSF1	K062906	000
EMICEHTSF10	K062906	000
EMICEHTSF11	K062906	000
EMICEHR6T0	K062906	000
EMICEHFB30	K062906	000
EMICEHFB31	K062906	000
EMICEHFB40	K062906	000
EMICEFFUD10	K062906	000
EMICEFFUD11	K062906	000
EMICEH2OBN1	K062906	000
EMICEHF1N0	K062906	000
EMICEHF1N1	K062906	000
EMICEHF3N0	K062906	000
EMICEHF3N1	K062906	000
EMICEHF4N0	K062906	000
EMICEHF4N1	K062906	000
EMICEHF5N0	K062906	000
EMICEHF5N1	K062906	000
EMICEHF6N0	K062906	000
EMICEHF6N1	K062906	000
EMICEHF7N0	K062906	000
EMICEHF7N1	K062906	000
EMICEH2OBN0	K062906	000
EMICEH2OA1	K062906	000
EMICEFFUD20	K062906	000
EMICEFFUD21	K062906	000
EMICEFFUD30	K062906	000
EMICEFFUD31	K062906	000
EMICEFFUD350	K062906	000
EMICEFFUD351	K062906	000
EMICEFFUD40	K062906	000
EMICEFFUD41	K062906	000
EMICEFFUD50	K062906	000
EMICEFFUD51	K062906	000
EMICEFFUD60	K062906	000
EMICEFFUD61	K062906	000
EMICEH2OA0	K062906	000
EMICEHF8N0	K062906	000
EMICEHRFUD351	K062906	000
EMICEHRUE11	K062906	000
EMICERBD30	K062906	000
EMICERBD40	K062906	000
EMICERBF10	K062906	000
EMICERBF11	K062906	000
EMICERBF20	K062906	000
EMICERBF21	K062906	000
EMICERBF30	K062906	000
EMICERBF31	K062906	000
EMICEREF10	K062906	000
EMICEREF11	K062906	000
EMICEREF20	K062906	000
EMICEREF21	K062906	000
EMICEREF30	K062906	000
EMICERBD20	K062906	000
EMICERBD10	K062906	000
EMICEHRUE20	K062906	000
EMICEHRUE21	K062906	000
EMICEHRUE30	K062906	000
EMICEHRUE31	K062906	000
EMICEHTOA1	K062906	000
EMICEHTOBN1	K062906	000
EMICEHTUD31	K062906	000
EMICER3E0	K062906	000
EMICER3E1	K062906	000
EMICER3FB0	K062906	000
EMICER3FB1	K062906	000
EMICER3FC0	K062906	000
EMICER3FC1	K062906	000
EMICEREF31	K062906	000
EMICERIW0	K062906	000
EMICERUD40	K062906	000
EMICERUD41	K062906	000
EMICERUD50	K062906	000
EMICERUD51	K062906	000
EMICERUE10	K062906	000
EMICERUE11	K062906	000
EMICERUE20	K062906	000
EMICERUE21	K062906	000
EMICERUE30	K062906	000
EMICERUE31	K062906	000
EMICETPKIT0	K062906	000
EMICETPKIT1	K062906	000
EMICETST0	K062906	000
EMICERUD351	K062906	000
EMICERUD350	K062906	000
EMICERIW1	K062906	000
EMICERIWS0	K062906	000
EMICERIWS1	K062906	000
EMICERUD00	K062906	000
EMICERUD01	K062906	000
EMICERUD050	K062906	000
EMICERUD051	K062906	000
EMICERUD10	K062906	000
EMICERUD11	K062906	000
EMICERUD20	K062906	000
EMICERUD21	K062906	000
EMICERUD30	K062906	000
EMICERUD31	K062906	000
EMICETST1	K062906	000
EMICEHRUE10	K062906	000
EMICEHRFUD40	K062906	000
EMICEHRTBD31	K062906	000
EMICEHRTBD351	K062906	000
EMICEHRTBD41	K062906	000
EMICEHRTBD51	K062906	000
EMICEHRTBD61	K062906	000
EMICEHRTBF11	K062906	000
EMICEHRTBF21	K062906	000
EMICEHRTBF31	K062906	000
EMICEHRTEF11	K062906	000
EMICEHRTEF21	K062906	000
EMICEHRTEF31	K062906	000
EMICEHRTIM1	K062906	000
EMICEHRTIW1	K062906	000
EMICEHRTBD21	K062906	000
EMICEHRTBD11	K062906	000
EMICEHRFUD41	K062906	000
EMICEHRFUD50	K062906	000
EMICEHRFUD51	K062906	000
EMICEHRFUD60	K062906	000
EMICEHRFUD61	K062906	000
EMICEHRIM0	K062906	000
EMICEHRIM1	K062906	000
EMICEHRIW0	K062906	000
EMICEHRIW1	K062906	000
EMICEHRIWS0	K062906	000
EMICEHRIWS1	K062906	000
EMICEHRTBD01	K062906	000
EMICEHRTBD051	K062906	000
EMICEHRTIWS1	K062906	000
EMICEHRTUD01	K062906	000
EMICEHRUD10	K062906	000
EMICEHRUD11	K062906	000
EMICEHRUD20	K062906	000
EMICEHRUD21	K062906	000
EMICEHRUD30	K062906	000
EMICEHRUD31	K062906	000
EMICEHRUD350	K062906	000
EMICEHRUD351	K062906	000
EMICEHRUD40	K062906	000
EMICEHRUD41	K062906	000
EMICEHRUD50	K062906	000
EMICEHRUD51	K062906	000
EMICEHRUD60	K062906	000
EMICEHRUD051	K062906	000
EMICEHRUD050	K062906	000
EMICEHRTUD051	K062906	000
EMICEHRTUD11	K062906	000
EMICEHRTUD21	K062906	000
EMICEHRTUD31	K062906	000
EMICEHRTUD351	K062906	000
EMICEHRTUD41	K062906	000
EMICEHRTUD51	K062906	000
EMICEHRTUD61	K062906	000
EMICEHRTUE11	K062906	000
EMICEHRTUE21	K062906	000
EMICEHRTUE31	K062906	000
EMICEHRUD00	K062906	000
EMICEHRUD01	K062906	000
EMICEHRUD61	K062906	000