Naturelle

FDA 510(k) K823097 · Bauer, Cheng & Associates, Inc.

Substantially Equivalent

510(k) numberK823097

Submission

Device name
Naturelle
Applicant
Bauer, Cheng & Associates, Inc.
Mchenry, IL, US
Received
October 19, 1982
Decision date
November 10, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EJS – Alloy, Other Noble Metal
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3060
Specialty
Dental

Other 510(k)s with product code EJS

510(k)DeviceApplicantDecision
K041433Bright Gold XHEJS · Traditional Ivoclar Vivadent, Inc.08/19/2004SE
K040436Simidur SuperiorEJS · Traditional Wieland Dental + Technik GmbH & Co. KG03/05/2004SE
K022252Sterngold 1, Model 1127781EJS · Abbreviated Sterngold09/19/2002SE
K022469Eco E4EJS · Traditional Wieland Dental + Technik GmbH & Co. KG09/18/2002SE
K021367Sterngold 66, Model #1180230EJS · Abbreviated Sterngold05/16/2002SE
K020195Simidur S1SEJS · Traditional Wieland Dental + Technik GmbH & Co. KG03/15/2002SE
K020194Simidur KF PlusEJS · Traditional Wieland Dental + Technik GmbH & Co. KG03/15/2002SE
K020192Simidur S2EJS · Traditional Wieland Dental + Technik GmbH & Co. KG03/15/2002SE
K014042D.Sign 84EJS · Traditional Ivoclar Vivadent, Inc.02/22/2002SE
K013809D.Sign 59EJS · Traditional Ivoclar Vivadent, Inc.02/07/2002SE

More from Ivoclar Vivadent, Inc.

510(k)DeviceDecision
K840084Coltene Brilliant LuxEBF · Traditional 03/30/1984SE
K840085Coltene BrilliantEBF · Traditional 03/16/1984SE
K823100RX 91EJS · Traditional 11/10/1982SE
K823099RX MidacastEJT · Traditional 11/10/1982SE
K823098Rex-CapsEJJ · Traditional 11/10/1982SE
K823084ChallengerEJS · Traditional 11/10/1982SE
K810972The Gnathometer-MKZO · Traditional 05/05/1981SE
K810971The GnatometEJP · Traditional 05/05/1981SE
K810970Isosit TeethELM · Traditional 05/05/1981SE
K810969Isosit C & B MaterialEBF · Traditional 05/05/1981SE

Questions and answers

When was Naturelle cleared by the FDA?

Naturelle (K823097) received a 510(k) decision of Substantially Equivalent on November 10, 1982, 22 days after the submission was received.

What is the product code of K823097?

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