Admira Fusion

Material, Tooth Shade, Resin

VOCO GMBH

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

Pre-market Notification Details

• Device ID: K150784
• 510k Number: K150784
• Device Name: Admira Fusion
• Classification: Material, Tooth Shade, Resin
• Applicant: VOCO GMBH ANTON-FLETTNER-STR. 1-3 Cuxhaven, DE 27472
• Contact: M Th Plaumann
• Correspondent: T Gerkensmeier; VOCO GMBH ANTON-FLETTNER-STR. 1-3 Cuxhaven, DE 27472
• Product Code: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-03-25
• Decision Date: 2015-07-02

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
E22127771	K150784	000
E22127561	K150784	000
E22127571	K150784	000
E22127581	K150784	000
E22127591	K150784	000
E22127601	K150784	000
E22127621	K150784	000
E22127631	K150784	000
E22127641	K150784	000
E22127661	K150784	000
E22127681	K150784	000
E22127701	K150784	000
E22127551	K150784	000
E22127541	K150784	000
E22127521	K150784	000
E22128050	K150784	000
E22124811	K150784	000
E22124821	K150784	000
E22124831	K150784	000
E22124841	K150784	000
E22124861	K150784	000
E22124911	K150784	000
E22124921	K150784	000
E22124931	K150784	000
E22124941	K150784	000
E22127511	K150784	000
E22127711	K150784	000
E22127721	K150784	000
E22127911	K150784	000
E22127921	K150784	000
E22127941	K150784	000
E22127961	K150784	000
E22127981	K150784	000
E22127991	K150784	000
E22128001	K150784	000
E22128011	K150784	000
E22128031	K150784	000
E22128041	K150784	000
E22128061	K150784	000
E22127901	K150784	000
E22127881	K150784	000
E22127871	K150784	000
E22127731	K150784	000
E22127751	K150784	000
E22127761	K150784	000
E22127781	K150784	000
E22127791	K150784	000
E22127811	K150784	000
E22127821	K150784	000
E22127831	K150784	000
E22127841	K150784	000
E22127851	K150784	000
E22127861	K150784	000
E22128091	K150784	000