Vericore Zirconia Blanks
FDA 510(k) K140877 · Whip Mix Corp.
510(k) numberK140877
Submission
- Device name
- Vericore Zirconia Blanks
- Applicant
- Whip Mix Corp.
Louisville, KY, US - Received
- April 7, 2014
- Decision date
- September 3, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K262195 | Dandy Ceramic Stain and GlazeEIH · Traditional | Zima International Inc., dba Dandy | 06/30/2026SE |
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| K260067 | Eternal Art Porcelain PowdersEIH · Traditional | Shandong Huge Dental Material Corporation | 04/09/2026SE |
| K260370 | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankEIH · Traditional | Bloomden Bioceramics (HuNan) Co., Ltd. | 03/30/2026SE |
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More from Ivoclar Vivadent, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K241729 | Hard Splint & Thermo-Adaptive SplintMQC · Traditional | 03/18/2025SE |
| K190107 | VeriSplintMQC · Traditional | 07/10/2019SE |
| K152443 | Vericore Gradient Temporary DiscEBG · Traditional | 05/11/2016SE |
| K142670 | Vericore Zirconia BlanksEIH · Special | 10/22/2014SE |
| K140146 | Comfortsoft Soft Denture Liner SystemEBI · Traditional | 04/29/2014SE |
| K131760 | Whip Mix Preppies PlusEJR · Traditional | 03/26/2014SE |
| K092857 | Vericore Abutment in Titanium for Implant SystemsNHA · Traditional | 03/04/2010SE |
| K090976 | Vericore Abutment in Zirconia for Implant SystemsNHA · Traditional | 06/25/2009SE |
| K082299 | Vericore Implant AbutmentsNHA · Traditional | 11/20/2008SE |
Questions and answers
When was Vericore Zirconia Blanks cleared by the FDA?
Vericore Zirconia Blanks (K140877) received a 510(k) decision of Substantially Equivalent on September 3, 2014, 149 days after the submission was received.
What is the product code of K140877?
The FDA product code is EIH – Powder, Porcelain, a Class II (moderate risk) device regulated under 21 CFR 872.6660.