Cleared Traditional

K071182 - PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013
(FDA 510(k) Clearance)

K071182 · Nobel Biocare AB · Dental

Jul 2007

Decision

72d

Days

Class 2

Risk

K071182 is an FDA 510(k) clearance for the PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013. This device is classified as a Teeth, Porcelain (Class II — Special Controls, product code ELL).

Submitted by Nobel Biocare AB (Yorba Linda,, US). The FDA issued a Cleared decision on July 11, 2007, 72 days after receiving the submission on April 30, 2007.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3920.

Submission Details

510(k) Number	K071182 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 30, 2007
Decision Date	July 11, 2007
Days to Decision	72 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF