GRANDIO

Material, Tooth Shade, Resin

VOCO GMBH

The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Grandio.

Pre-market Notification Details

• Device ID: K051867
• 510k Number: K051867
• Device Name: GRANDIO
• Classification: Material, Tooth Shade, Resin
• Applicant: VOCO GMBH 19379 BLUE LAKE LOOP Bend, OR 97702
• Contact: Gerald W Shipps
• Correspondent: Gerald W Shipps; VOCO GMBH 19379 BLUE LAKE LOOP Bend, OR 97702
• Product Code: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-07-11
• Decision Date: 2005-07-27

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
E22118551	K051867	000
E22118231	K051867	000
E22118221	K051867	000
E22118211	K051867	000
E22118201	K051867	000
E22118191	K051867	000
E22118181	K051867	000
E22118171	K051867	000
E22118161	K051867	000
E22118151	K051867	000
E22118141	K051867	000
E22118131	K051867	000
E22118121	K051867	000
E22118111	K051867	000
E22118101	K051867	000
E22118081	K051867	000
E22118051	K051867	000
E22118241	K051867	000
E22118251	K051867	000
E22118301	K051867	000
E22118541	K051867	000
E22118531	K051867	000
E22118521	K051867	000
E22118511	K051867	000
E22118501	K051867	000
E22118491	K051867	000
E22118481	K051867	000
E22118471	K051867	000
E22118461	K051867	000
E22118451	K051867	000
E22118441	K051867	000
E22118431	K051867	000
E22118421	K051867	000
E22118411	K051867	000
E22118401	K051867	000
E22118381	K051867	000
E22118001	K051867	000