510(k) K081263
- Device
- STARCERAM
- Applicant
- H.C. STARCK CERAMICS GMBH & CO.KG
- 510(k) number
- K081263
- Product code
- EIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-07-01
- Date received
- 2008-05-05
- Regulation
- 872.6660
- Classification name
- Powder, Porcelain
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT N CLARK
- Address
- 13605 W. 7th Ave. Golden CO US 80401 80401
FDA Registration Numbers#
- 3013934196
- 3042370495
- 3008582406
- 3031841433
- 3031595584
- 3017619362
- 3039433962
- 3034729565
- 3044819802
- 3042244574
- 1064583
- 3031915955
- 3035983708
- 3008564629
- 3014311922
- 3038715999
- 3002889488
- 3025436468
- 3015332784
- 3024792419
- 3011649314
- 3011221537
- 3023272670
- 9612352
- 3010564008
- 3034729999
- 3013513796
- 3005904906
- 3006146796
- 3009409473
- 3018411778
- 9611385
- 3013136463
- 3031886796
- 3002808149
- 3025604798
- 9611458
- 9612468
- 3012354669
- 1718912
- 3008578884
- 1420052
- 3008383146
- 3030536692
- 3015108415
- 3009432160
- 3011824442
- 9613953
- 2023817
- 3009740550
- 3000219976
- 3009081830
- 3012867029
- 3009312656
- 2023129
- 3002807050
- 3013584861
- 3027341558
- 3003775534
- 3017674095
- 3024185724
- 2436986
- 3035693034
- 3045857207
- 3012187973
- 3022068322
- 3021284321
- 3013546336
- 3019784699
- 3014683120
- 3012494290
- 3006235664
- 2523320
- 3008320092
- 1219645
- 3009482106
- 8031058
- 3008912871
- 3049848172
Source Documents#
Other 510(k) Records For Product Code EIH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K252789 | Glass Ceramic | Shenzhen Xiangtong Co., Ltd. | 2025-12-08 |
| K252446 | BruxZir® NOW | Prismatik Dentalcraft, Inc. | 2025-09-03 |
| K251593 | DenMat Multilayered Zirconia Disc | Denmat Holding, LLC | 2025-08-25 |
Legacy Summary#
summary
FDA Review#
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