Dental Amalgam Alloy (Spherical II)
FDA 510(k) K760379 · L.D. Caulk Co.
510(k) numberK760379
Submission
- Device name
- Dental Amalgam Alloy (Spherical II)
- Applicant
- L.D. Caulk Co.
Mchenry, IL, US - Received
- August 5, 1976
- Decision date
- August 23, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EJS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K041433 | Bright Gold XHEJS · Traditional | Ivoclar Vivadent, Inc. | 08/19/2004SE |
| K040436 | Simidur SuperiorEJS · Traditional | Wieland Dental + Technik GmbH & Co. KG | 03/05/2004SE |
| K022252 | Sterngold 1, Model 1127781EJS · Abbreviated | Sterngold | 09/19/2002SE |
| K022469 | Eco E4EJS · Traditional | Wieland Dental + Technik GmbH & Co. KG | 09/18/2002SE |
| K021367 | Sterngold 66, Model #1180230EJS · Abbreviated | Sterngold | 05/16/2002SE |
| K020195 | Simidur S1SEJS · Traditional | Wieland Dental + Technik GmbH & Co. KG | 03/15/2002SE |
| K020194 | Simidur KF PlusEJS · Traditional | Wieland Dental + Technik GmbH & Co. KG | 03/15/2002SE |
| K020192 | Simidur S2EJS · Traditional | Wieland Dental + Technik GmbH & Co. KG | 03/15/2002SE |
| K014042 | D.Sign 84EJS · Traditional | Ivoclar Vivadent, Inc. | 02/22/2002SE |
| K013809 | D.Sign 59EJS · Traditional | Ivoclar Vivadent, Inc. | 02/07/2002SE |
More from Ivoclar Vivadent, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K802262 | Composite Restorative · Traditional | 09/16/1980SESP |
| K801690 | ValiantEJJ · Traditional | 08/13/1980SE |
| K790586 | ChembondEMA · Traditional | 05/16/1979SE |
| K790585 | FinesseEBF · Traditional | 05/16/1979SE |
| K780560 | Dental AmalgamatorEFD · Traditional | 04/21/1978SE |
| K780384 | Improved DycalEJK · Traditional | 03/15/1978SE |
| K780301 | Caulk TylokEMA · Traditional | 02/28/1978SE |
| K771402 | Nuva-Cote (Modification to)EBC · Traditional | 08/26/1977SE |
| K771399 | Lip & Cheek RetractorEIG · Traditional | 08/26/1977SE |
| K771398 | Shell VeneerELM · Traditional | 08/26/1977SE |
Questions and answers
When was Dental Amalgam Alloy (Spherical II) cleared by the FDA?
Dental Amalgam Alloy (Spherical II) (K760379) received a 510(k) decision of Substantially Equivalent on August 23, 1976, 18 days after the submission was received.
What is the product code of K760379?
The FDA product code is EJS – Alloy, Other Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.