Carrara Porcelain and Carrara Vincent Porcelain
FDA 510(k) K981000 · European Dental Imports, Inc.
510(k) numberK981000
Submission
- Device name
- Carrara Porcelain and Carrara Vincent Porcelain
- Applicant
- European Dental Imports, Inc.
Durham, NH, US - Received
- March 18, 1998
- Decision date
- May 15, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K253191 | DCMhotbond zirconEIH · Traditional | Dental Creativ Management GmbH | 05/21/2026SE |
| 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 |
|---|---|---|
| K982129 | Antagon PorcelainEIH · Traditional | 08/04/1998SE |
| K981002 | Orion WX Dental AlloyEJS · Traditional | 05/18/1998SE |
| K981001 | Orion Vesta Dental AlloyEJS · Traditional | 05/18/1998SE |
| K980661 | Cera E Dental AlloyEJS · Traditional | 05/01/1998SE |
| K980660 | Biogold Plus Dental AlloyEJT · Traditional | 04/27/1998SE |
| K980597 | Carrara PDF, Carrara H, Carrara REJT · Traditional | 03/09/1998SE |
Questions and answers
When was Carrara Porcelain and Carrara Vincent Porcelain cleared by the FDA?
Carrara Porcelain and Carrara Vincent Porcelain (K981000) received a 510(k) decision of Substantially Equivalent on May 15, 1998, 58 days after the submission was received.
What is the product code of K981000?
The FDA product code is EIH – Powder, Porcelain, a Class II (moderate risk) device regulated under 21 CFR 872.6660.