JENSEN ZIRCONIA

Powder, Porcelain

JENSEN INDUSTRIES, INC.

The following data is part of a premarket notification filed by Jensen Industries, Inc. with the FDA for Jensen Zirconia.

Pre-market Notification Details

• Device ID: K112806
• 510k Number: K112806
• Device Name: JENSEN ZIRCONIA
• Classification: Powder, Porcelain
• Applicant: JENSEN INDUSTRIES, INC. 50 STILLMAN RD. North Haven, CT 06473
• Contact: Gary Phelps
• Correspondent: Gary Phelps; JENSEN INDUSTRIES, INC. 50 STILLMAN RD. North Haven, CT 06473
• Product Code: EIH
• CFR Regulation Number: 872.6660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-09-27
• Decision Date: 2011-12-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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00817340025088	K112806	000
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