Cera E Dental Alloy

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K980661 ↗

FDA Product Code

EJS

Device Class

Class II

Regulation

21 CFR Part 872.3060

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Orion Vesta Dental Alloy

  Class II

  FDA 510(k) K981001 Active Cleared 18 May 1998

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  Class II

  FDA 510(k) K980660 Active Cleared 27 Apr 1998

• Antagon Porcelain

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  FDA 510(k) K982129 Active Cleared 4 Aug 1998

• Orion Wx Dental Alloy

  Class II

  FDA 510(k) K981002 Active Cleared 18 May 1998

• Carrara Pdf, Carrara H, Carrara R

  Class II

  FDA 510(k) K980597 Active Cleared 9 Mar 1998

• Carrara Porcelain and Carrara Vincent Porcelain

  Class II

  FDA 510(k) K981000 Active Cleared 15 May 1998

• What is the CERA E Dental Alloy used for?

  The CERA E Dental Alloy is used by a dental lab technician under the direction of an attending dentist to cast elements of fixed and removable dental prostheses, including precious metal inlays, onlays, crowns, bridges, bars, and attachments. This is based on the device description specifying its application in dental laboratory work for prosthetic fabrication.

• Is the CERA E Dental Alloy supplied sterile or non-sterile, and can it be reused?

  The device is supplied non-sterile and is intended for reuse after appropriate cleaning and sterilization by the user, as explicitly stated in the description. This means the end-user must perform sterilization prior to each clinical use.

• How should the CERA E Dental Alloy be stored?

  The device is stored under standard conditions, as indicated in the description. No special temperature, humidity, or environmental controls are specified beyond standard storage practices for dental alloys.

• What regulatory pathway was used for the CERA E Dental Alloy, and what is its classification?

  The CERA E Dental Alloy received authorization via the FDA 510(k) pathway and is classified as a Class 2 dental device with product code EJS, as stated in the NAME, AUTHORIZATIONS, and DESCRIPTION fields. The decision_code: SESE and product_code: EJS.

• What is the product code and regulation number for the CERA E Dental Alloy?

  The product code is EJS and the regulation number is 872.3060, as directly listed in the SPECIFICATIONS section under product_code and regulation_number. These identifiers are used for regulatory classification and tracking.