Valiant

FDA 510(k) K801690 · L.D. Caulk Co.

Substantially Equivalent

510(k) numberK801690

Submission

Device name
Valiant
Applicant
L.D. Caulk Co.
Mchenry, IL, US
Received
July 23, 1980
Decision date
August 13, 1980
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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
K802262Composite Restorative · Traditional 09/16/1980SESP
K790586ChembondEMA · Traditional 05/16/1979SE
K790585FinesseEBF · Traditional 05/16/1979SE
K780560Dental AmalgamatorEFD · Traditional 04/21/1978SE
K780384Improved DycalEJK · Traditional 03/15/1978SE
K780301Caulk TylokEMA · Traditional 02/28/1978SE
K771402Nuva-Cote (Modification to)EBC · Traditional 08/26/1977SE
K771399Lip & Cheek RetractorEIG · Traditional 08/26/1977SE
K771398Shell VeneerELM · Traditional 08/26/1977SE
K771403Ease (Modification to)EJJ · Traditional 08/22/1977SE

Questions and answers

When was Valiant cleared by the FDA?

Valiant (K801690) received a 510(k) decision of Substantially Equivalent on August 13, 1980, 21 days after the submission was received.

What is the product code of K801690?

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