510(k) K262685
- Device
- Zirconia Collective 4Y Dental Zirconia Blank
- Applicant
- Zirconia Collective, Inc.
- 510(k) number
- K262685
- Product code
- EIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-10-30
- Date received
- 2026-07-31
- Regulation
- 872.6660
- Classification name
- Powder, Porcelain
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Gerard Giuliano Jr
- Address
- 10860 Dover St. Suite 2500 Westminster CO US 80021 80021
FDA Registration Numbers#
- 2018957
- 3017450159
- 3031595584
- 1420052
- 2647456
- 3008912871
- 3025436468
- 3011824442
- 9613953
- 3013551048
- 2082832
- 3034244245
- 1725006
- 9612618
- 3018249917
- 9612352
- 3006235664
- 3012187973
- 3008578884
- 3008347275
- 3027481489
- 3003310824
- 3003775534
- 3045855232
- 3027341558
- 3009727738
- 3007160911
- 8031058
- 3009496224
- 2244842
- 3012441963
- 3022068322
- 3032163716
- 3006223010
- 1000118628
- 3009312656
- 3006146796
- 3040605150
- 3038718579
- 3004491043
- 3008254125
- 3009740550
- 3009482106
- 3009409473
- 3009081830
- 3013102320
- 8010711
- 3010905160
- 3035693034
- 3030536692
- 3019784699
- 3025604798
- 3007597023
- 9613348
- 3015332784
- 3017619362
- 3030515618
- 3035983708
- 3005974404
- 3031841433
- 3008190898
- 3013513796
- 3012867029
- 3013342350
- 3004905070
- 1222802
- 2424472
- 3045857207
- 3012354669
- 3031915955
- 3014945384
- 3034605324
- 3008383146
- 3049848172
- 3042370495
- 3031605796
- 3014980456
- 3009300369
- 1420089
Source Documents#
Other 510(k) Records For Product Code EIH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262756 | Zirconia Dental Ceramics and Staining Solution | Fanen New Materials Technology (Suzhou) Co., Ltd. | 2026-10-29 |
| K262980 | INNI-CERA (BCM-W500, BCM-W1000) | DentMedi Co., Ltd. | 2026-10-21 |
| K262523 | Amber Arte | Hass Corp. | 2026-10-16 |
| K262074 | Any-Zircos | Mediclus Co., Ltd. | 2026-08-21 |
| K262239 | Obsidian® Press Over Zirconia | Prismatik Dentalcraft, Inc. | 2026-07-30 |
| K261046 | Dental Zirconia Blank & Coloring Liquid | Hunan Qinghao Puzhong Technology Co., Ltd. | 2026-07-17 |
| K262195 | Dandy Ceramic Stain and Glaze | Zima International Inc., dba Dandy | 2026-06-30 |
| K260918 | Zolid Lunaris | Amann Girrbach AG | 2026-06-29 |
| K260859 | Rosetta SM, Rosetta SP | Hass Corp. | 2026-06-11 |
| K253191 | DCMhotbond zircon | Dental Creativ Management GmbH | 2026-05-21 |
| K260067 | Eternal Art Porcelain Powders | Shandong Huge Dental Material Corporation | 2026-04-09 |
| K260370 | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Bloomden Bioceramics (HuNan) Co., Ltd. | 2026-03-30 |
| K253953 | IPS e.max Zirconia | Ivoclar Vivadent, Inc. | 2026-03-10 |
| K254283 | BruxZir® Shaded 16 PLUS | Prismatik Dentalcraft, Inc. | 2026-01-30 |
| K253973 | Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series | Liaoning Upcera Co., Ltd. | 2026-01-09 |