Vivacap HR

FDA 510(k) K982460 · Ab Ardent

Substantially Equivalent

510(k) numberK982460

Submission

Device name
Vivacap HR
Applicant
Ab Ardent
Tonawanda, NY, US
Received
July 15, 1998
Decision date
August 24, 1998
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

Other 510(k)s with product code EJJ

510(k)DeviceApplicantDecision
K053114SilverfilEJJ · Traditional Dunia Perwira Manufacturing Sdn. Bhd.11/15/2005SE
K051010Securalloy, Septalloy NG 50 and Septalloy NG 70EJJ · Special Septodont05/02/2005SE
K033434BestaloyEJJ · Traditional We Dong Myung Dental Industrial Co., Ltd.11/12/2003SE
K032152Benco AdmixEJJ · Traditional Southern Dental Industries, Inc.08/06/2003SE
K031658Benco SphericalEJJ · Traditional Southern Dental Industries, Inc.07/29/2003SE
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

More from Nordiska Dental AB

510(k)DeviceDecision
K131753MeridianEBF · Abbreviated 11/14/2013SE
K040465Latit FlowEBF · Traditional 07/20/2004SE
K022971Microhybrid 11EBF · Traditional 11/25/2002SE
K022975Etching 15EBF · Traditional 11/22/2002SE
K022974Microhybrid 12EBF · Traditional 11/22/2002SE
K022973Adhesive 14KLE · Traditional 11/22/2002SE
K022972Microfill 13EBF · Traditional 11/22/2002SE
K020452High Silver ConventionalEJJ · Traditional 05/07/2002SE
K011801Futura Topcap Non GAMMA-2EJJ · Traditional 08/16/2001SE
K991974Futura Glass Ionomer Silver ReinforcedEMA · Traditional 09/17/1999SE

Questions and answers

When was Vivacap HR cleared by the FDA?

Vivacap HR (K982460) received a 510(k) decision of Substantially Equivalent on August 24, 1998, 40 days after the submission was received.

What is the product code of K982460?

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