Aigis-Soft

FDA 510(k) K024136 · Sb Lucius, Inc.

Substantially Equivalent

510(k) numberK024136

Submission

Device name
Aigis-Soft
Applicant
Sb Lucius, Inc.
Anaheim, CA, US
Received
December 16, 2002
Decision date
March 10, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EJT – Alloy, Gold-Based Noble Metal
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3060
Specialty
Dental

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K040043NDX-40 AlloyEJT · Traditional Heraeus Kulzer, Inc.03/03/2004SE
K034049Herador Ec, PF, C, H, NH, G, GG and MP; Heraloy U and G; Herabond N; Albabond C, B and…EJT · Traditional Heraeus Kulzer,GmbH03/01/2004SE
K033279Gold Dental Casting AlloysEJT · Traditional Bego U.S.A.01/15/2004SE
K033446APEX93, APEX87, APEX84, APEX85, APEX77, E-Sarang 88 and E-Sarang 82EJT · Traditional We Dong Myung Dental Industrial Co., Ltd.11/13/2003SE
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K032320Appollo 3 AlloyEJT · Traditional Dentsply International10/01/2003SE

More from Dentsply International

510(k)DeviceDecision
K031010Miracle 98EJT · Traditional 06/25/2003SE
K024143Aigis-FineEJT · Traditional 03/10/2003SE
K024142Aigis-SuperEJT · Traditional 03/10/2003SE
K024135Aigis-PlusEJT · Traditional 03/10/2003SE
K024145Aigis-XoEJT · Traditional 03/07/2003SE
K024144Aigis-PtEJT · Traditional 03/07/2003SE
K024139Aigis-InlayEJT · Traditional 03/07/2003SE
K024141Neo 76EJT · Traditional 03/06/2003SE
K024140Aigis-AEJT · Traditional 03/06/2003SE
K023197Ceranum 82EJT · Traditional 11/05/2002SE

Questions and answers

When was Aigis-Soft cleared by the FDA?

Aigis-Soft (K024136) received a 510(k) decision of Substantially Equivalent on March 10, 2003, 84 days after the submission was received.

What is the product code of K024136?

The FDA product code is EJT – Alloy, Gold-Based Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.