Eris Layering Materials
FDA 510(k) K012174 · Ivoclar North America, Inc.
510(k) numberK012174
Submission
- Device name
- Eris Layering Materials
- Applicant
- Ivoclar North America, Inc.
Amherst, NY, US - Received
- July 12, 2001
- Decision date
- August 27, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K253953 | IPS e.max ZirconiaEIH · Traditional | Ivoclar Vivadent, Inc. | 03/10/2026SE |
More from Ivoclar Vivadent, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K011491 | Helioseal Clear ChromaEBC · Traditional | 08/16/2001SE |
| K011492 | In Ten-SEBF · Traditional | 07/05/2001SE |
| K011490 | Modification to ExciteKLE · Traditional | 06/27/2001SE |
| K011023 | D.Sign 96EJT · Traditional | 05/02/2001SE |
| K011022 | Biouniversal PDFEJT · Traditional | 05/02/2001SE |
| K010381 | D.Sign 30EJH · Traditional | 03/06/2001SE |
| K010250 | Tetric Ceram HBEBF · Traditional | 02/28/2001SE |
| K003293 | Excite DSCKLE · Traditional | 02/06/2001SE |
| K003407 | Systemp.Desensitizer (Vivadent.Desensitizer)EMA · Traditional | 01/26/2001SE |
| K003635 | DW 276 #3EJT · Traditional | 12/22/2000SE |
Questions and answers
When was Eris Layering Materials cleared by the FDA?
Eris Layering Materials (K012174) received a 510(k) decision of Substantially Equivalent on August 27, 2001, 46 days after the submission was received.
What is the product code of K012174?
The FDA product code is EIH – Powder, Porcelain, a Class II (moderate risk) device regulated under 21 CFR 872.6660.