Benco Spherical

FDA 510(k) K031658 · Southern Dental Industries, Inc.

Substantially Equivalent

510(k) numberK031658

Submission

Device name
Benco Spherical
Applicant
Southern Dental Industries, Inc.
Bensenville, IL, US
Received
May 28, 2003
Decision date
July 29, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
EJJ – Alloy, Amalgam
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3070
Specialty
Dental

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K053114SilverfilEJJ · Traditional Dunia Perwira Manufacturing Sdn. Bhd.11/15/2005SE
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K033434BestaloyEJJ · Traditional We Dong Myung Dental Industrial Co., Ltd.11/12/2003SE
K032152Benco AdmixEJJ · Traditional Southern Dental Industries, Inc.08/06/2003SE
K020452High Silver ConventionalEJJ · Traditional Ab Ardent05/07/2002SE
K011801Futura Topcap Non GAMMA-2EJJ · Traditional Ab Ardent08/16/2001SE
K002811Ana 70 Non Gamma 2 Dispersed Phase Dental AlloyEJJ · Traditional Nordiska Dental AB10/31/2000SE
K002810Ana 3000 SM Non Gamma 2 Modified Spherical Dental AlloyEJJ · Traditional Nordiska Dental AB10/31/2000SE
K002808Ana 2000 Non Gamma 2 Extra High Copper Dental AlloyEJJ · Traditional Nordiska Dental AB10/31/2000SE
K991481ParagonEJJ · Traditional Lancer Orthodontics, Inc.08/11/1999SE

More from Lancer Orthodontics, Inc.

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K050871Riva ProtectEBC · Traditional 06/10/2005SE
K050870Riva Light CureEMA · Traditional 06/03/2005SE
K050331Adhesive 1KLE · Traditional 03/24/2005SE
K042452Riva SilverEMA · Traditional 12/07/2004SE
K040393Riva LutingEMA · Traditional 04/30/2004SE
K032152Benco AdmixEJJ · Traditional 08/06/2003SE
K030568RadiiEBZ · Traditional 04/24/2003SE

Questions and answers

When was Benco Spherical cleared by the FDA?

Benco Spherical (K031658) received a 510(k) decision of Substantially Equivalent on July 29, 2003, 62 days after the submission was received.

What is the product code of K031658?

The FDA product code is EJJ – Alloy, Amalgam, a Class II (moderate risk) device regulated under 21 CFR 872.3070.