Luminesse Anterior Zirconia AT
FDA 510(k) K152066 · Talladium, Inc.
510(k) numberK152066
Submission
- Device name
- Luminesse Anterior Zirconia AT
- Applicant
- Talladium, Inc.
Valencia, CA, US - Received
- July 24, 2015
- Decision date
- October 21, 2015
- 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 |
| K253953 | IPS e.max ZirconiaEIH · Traditional | Ivoclar Vivadent, Inc. | 03/10/2026SE |
More from Ivoclar Vivadent, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K152023 | Luminesse Shaded Zirconia SZEIH · Traditional | 09/15/2016SE |
| K143090 | Luminesse Pre-Sintered Zirconia Coloring LiquidEIH · Traditional | 06/15/2015SE |
| K142371 | Luminesse PMMAEBG · Traditional | 04/24/2015SE |
| K140848 | Luminesse Porcelain SystemEIH · Traditional | 12/17/2014SE |
| K100232 | Luminesse ZR BlanksEIH · Abbreviated | 05/21/2010SE |
| K894085 | Talladium Tilite Ceramic AlloyEJH · Traditional | 12/20/1989SE |
Questions and answers
When was Luminesse Anterior Zirconia AT cleared by the FDA?
Luminesse Anterior Zirconia AT (K152066) received a 510(k) decision of Substantially Equivalent on October 21, 2015, 89 days after the submission was received.
What is the product code of K152066?
The FDA product code is EIH – Powder, Porcelain, a Class II (moderate risk) device regulated under 21 CFR 872.6660.