Bak-On SP Porcelain Alloy
FDA 510(k) K812101 · Johnson & Johnson Professionals, Inc.
510(k) numberK812101
Submission
- Device name
- Bak-On SP Porcelain Alloy
- Applicant
- Johnson & Johnson Professionals, Inc.
Raynham, MA, US - Received
- July 24, 1981
- Decision date
- August 18, 1981
- 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 |
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| K983141 | Capitello-Condylar Total Elbow ProsthesisJDB · Traditional | 11/06/1998SE |
| K983014 | Summit Acetabular SystemLPH · Traditional | 10/27/1998SE |
| K980778 | Hakim Micro Programmable Valve SystemJXG · Traditional | 07/17/1998SE |
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| K980801 | J-Fx Bipolar HeadKWY · Traditional | 05/29/1998SE |
Questions and answers
When was Bak-On SP Porcelain Alloy cleared by the FDA?
Bak-On SP Porcelain Alloy (K812101) received a 510(k) decision of Substantially Equivalent on August 18, 1981, 25 days after the submission was received.
What is the product code of K812101?
The FDA product code is EJS – Alloy, Other Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.