VITABLOCS

Powder, Porcelain

VITA ZAHNFABRIK H. RAUTER GMBH & CO.

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

Pre-market Notification Details

• Device ID: K102128
• 510k Number: K102128
• Device Name: VITABLOCS
• Classification: Powder, Porcelain
• Applicant: VITA ZAHNFABRIK H. RAUTER GMBH & CO. 3150 EAST BIRCH STREET Brea, CA 92821
• Contact: Elizabeth Wolfsen
• Correspondent: Daniel W Lehtonen; INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087
• Product Code: EIH
• CFR Regulation Number: 872.6660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2010-07-29
• Decision Date: 2010-08-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
J017EN1SASETCCM0	K102128	000
J017EC4B2CTF14140	K102128	000
J017EC4B3CTF1250	K102128	000
J017EC4B3CTF140	K102128	000
J017EC4B3CTF14140	K102128	000
J017EC4C2CTF1250	K102128	000
J017EC4C2CTF140	K102128	000
J017EC4C2CTF14140	K102128	000
J017EC4C3CTF1250	K102128	000
J017EC4B2CTF140	K102128	000
J017EC4B2CTF1250	K102128	000
J017EC40M1CTF14140	K102128	000
J017EC41M1CTF14140	K102128	000
J017EC4B1CI1050	K102128	000
J017EC4B1CI1250	K102128	000
J017EC4B1CI140	K102128	000
J017EC4B1CTF1250	K102128	000
J017EC4B1CTF140	K102128	000
J017EC4B1CTF14140	K102128	000
J017EC4C3CTF140	K102128	000
J017EC4C3CTF14140	K102128	000
J017EC4STKITS40	K102128	000
07630031703941	K102128	000
07630031703958	K102128	000
07630031703965	K102128	000
07630031703972	K102128	000
07630031703989	K102128	000
07630031703996	K102128	000
07630031704009	K102128	000
07630031704016	K102128	000
07630031703934	K102128	000
J017EC4A3CTF120	K102128	000
J017EC40M1CTF1250	K102128	000
J017EC40M1CTF140	K102128	000
J017EC41M1CTF1250	K102128	000
J017EC41M1CTF140	K102128	000
J017EC41M2CTF120	K102128	000
J017EC42M2CTF120	K102128	000
J017EC43M2CTF120	K102128	000
J017EC4A2CTF120	K102128	000
07630031704023	K102128	000