Renamel NANO +plus

Material, Tooth Shade, Resin

Cosmedent, Inc

The following data is part of a premarket notification filed by Cosmedent, Inc with the FDA for Renamel Nano +plus.

Pre-market Notification Details

• Device ID: K163480
• 510k Number: K163480
• Device Name: Renamel NANO +plus
• Classification: Material, Tooth Shade, Resin
• Applicant: Cosmedent, Inc 401 N Michigan Ave, Suite 2500 Chicago, IL 60611
• Contact: Hiren Patel
• Correspondent: Hiren Patel; Cosmedent, Inc 401 N Michigan Ave, Suite 2500 Chicago, IL 60611
• Product Code: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-12-12
• Decision Date: 2017-02-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
EDEL6005350	K163480	000
EDEL6006C10	K163480	000
EDEL6006B20	K163480	000
EDEL6006B10	K163480	000
EDEL6006B00	K163480	000
EDEL6006A40	K163480	000
EDEL6006A30	K163480	000
EDEL6006A20	K163480	000
EDEL6006A10	K163480	000
EDEL6006C20	K163480	000
EDEL6006C30	K163480	000
EDEL6006S30	K163480	000
EDEL6006S20	K163480	000
EDEL6006S10	K163480	000
EDEL6006MI0	K163480	000
EDEL6006LI0	K163480	000
EDEL6006D30	K163480	000
EDEL6006D20	K163480	000
EDEL6006C40	K163480	000
EDEL6006350	K163480	000
EDEL6005WI0	K163480	000
EDEL6005C10	K163480	000
EDEL6005B20	K163480	000
EDEL6005B10	K163480	000
EDEL6005B00	K163480	000
EDEL6005A40	K163480	000
EDEL6005A30	K163480	000
EDEL6005A20	K163480	000
EDEL6005A10	K163480	000
EDEL6005C20	K163480	000
EDEL6005C30	K163480	000
EDEL6005S30	K163480	000
EDEL6005S20	K163480	000
EDEL6005S10	K163480	000
EDEL6005MI0	K163480	000
EDEL6005LI0	K163480	000
EDEL6005D30	K163480	000
EDEL6005D20	K163480	000
EDEL6005C40	K163480	000
EDEL6006WI0	K163480	000
D7796005350	K163480	000
D7796006C41	K163480	000
D7796006C31	K163480	000
D7796006C21	K163480	000
D7796006C11	K163480	000
D7796006B21	K163480	000
D7796006B11	K163480	000
D7796006B01	K163480	000
D7796006A41	K163480	000
D7796006D21	K163480	000
D7796006D31	K163480	000
D7796005S10	K163480	000
D7796005C40	K163480	000
D7796006WI1	K163480	000
D7796006S31	K163480	000
D7796006S21	K163480	000
D7796006S11	K163480	000
D7796006MI1	K163480	000
D7796006LI1	K163480	000
D7796006A31	K163480	000
D7796006A21	K163480	000
D7796005C10	K163480	000
D7796005B20	K163480	000
D7796005B10	K163480	000
D7796005B00	K163480	000
D7796005A40	K163480	000
D7796005A30	K163480	000
D7796005A20	K163480	000
D7796005A10	K163480	000
D7796005C20	K163480	000
D7796005C30	K163480	000
D7796006A11	K163480	000
D7796006351	K163480	000
D7796005WI0	K163480	000
D7796005S30	K163480	000
D7796005MI0	K163480	000
D7796005LI0	K163480	000
D7796005D30	K163480	000
D7796005D20	K163480	000
D7796005S20	K163480	000