VITA Ambria

Powder, Porcelain

VITA Zahnfabrik GmbH H Rauter & Co

The following data is part of a premarket notification filed by Vita Zahnfabrik Gmbh H Rauter & Co with the FDA for Vita Ambria.

Pre-market Notification Details

• Device ID: K193436
• 510k Number: K193436
• Device Name: VITA Ambria
• Classification: Powder, Porcelain
• Applicant: VITA Zahnfabrik GmbH H Rauter & Co Spitelgasse 3 Bad Sackingen, DE D-79713
• Contact: Bernd Walker
• Correspondent: Lindsay Tilton; VITA North America 22705 Savi Ranch Parkway, Suite 100 Yorba Linda, CA 92887
• Product Code: EIH
• CFR Regulation Number: 872.6660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-12-11
• Decision Date: 2020-05-14

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
J017LAM040S02850	K193436	000
J017LAM040S01950	K193436	000
J017LAM040S02050	K193436	000
J017LAM040S02750	K193436	000
J017LAM040S03950	K193436	000
J017LAM040S04350	K193436	000
J017LAM040S04550	K193436	000
J017LAM040S04750	K193436	000
J017LAM040S05050	K193436	000
J017LAM070S07050	K193436	000
J017LAM070S07150	K193436	000
J017LAM070S07250	K193436	000
J017LAM030L00230	K193436	000
J017LAM030L00430	K193436	000
J017LAM030L03630	K193436	000
J017LAM030L03730	K193436	000
J017LAM040S01250	K193436	000
J017LAM040S01150	K193436	000
J017LAM030S00650	K193436	000
J017LAM030S00750	K193436	000
J017LAM030S01150	K193436	000
J017LAM030S01250	K193436	000
J017LAM030S01950	K193436	000
J017LAM030S02050	K193436	000
J017LAM030S02750	K193436	000
J017LAM030S02850	K193436	000
J017LAM030S03950	K193436	000
J017LAM030S04350	K193436	000
J017LAM030S04550	K193436	000
J017LAM030S04750	K193436	000
J017LAM030S05050	K193436	000
J017LAM040S00650	K193436	000
J017LAM040S00750	K193436	000
J017LAM030L03830	K193436	000
J017LAM030L04130	K193436	000
J017LAM040L04130	K193436	000
J017LAM040L04230	K193436	000
J017LAM040L04630	K193436	000
J017LAM040L04930	K193436	000
J017LAM040S00250	K193436	000
J017LAM040S00450	K193436	000
J017LAM040S03650	K193436	000
J017LAM040S03750	K193436	000
J017LAM040S03850	K193436	000
J017LAM040S04150	K193436	000
J017LAM040S04250	K193436	000
J017LAM040S04650	K193436	000
J017LAM040S04950	K193436	000
J017LAMSKC10	K193436	000
J017LAMTK0M10	K193436	000
J017LAM040L03830	K193436	000
J017LAM040L03730	K193436	000
J017LAM030L04230	K193436	000
J017LAM030L04630	K193436	000
J017LAM030L04930	K193436	000
J017LAM030S00250	K193436	000
J017LAM030S00450	K193436	000
J017LAM030S03650	K193436	000
J017LAM030S03750	K193436	000
J017LAM030S03850	K193436	000
J017LAM030S04150	K193436	000
J017LAM030S04250	K193436	000
J017LAM030S04650	K193436	000
J017LAM030S04950	K193436	000
J017LAM040L00230	K193436	000
J017LAM040L00430	K193436	000
J017LAM040L03630	K193436	000
J017LAMTKA10	K193436	000