510(k) K022796
- Device
- CERCON CERAM S PORCELAIN
- Applicant
- DENTSPLY INTL.
- 510(k) number
- K022796
- Product code
- EIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-09-06
- Date received
- 2002-08-23
- Regulation
- 872.6660
- Classification name
- Powder, Porcelain
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- P. JEFFERY LEHN
- Address
- 570 W. College Ave. York PA US 17405 17405
FDA Registration Numbers#
- 9614705
- 3009081830
- 3009482106
- 3021284321
- 3009432160
- 1000426619
- 3034244245
- 9611458
- 3009409473
- 3012421607
- 9681531
- 3025604798
- 3013513796
- 3031915955
- 1410097
- 9612352
- 3030536692
- 3008254125
- 3031886796
- 3014683120
- 3014311922
- 3005344553
- 3008347275
- 3013136463
- 3044819802
- 8031058
- 3006110126
- 3045855232
- 3027341558
- 1222802
- 1064583
- 3010127342
- 3030464310
- 3010564008
- 3012441963
- 3044771104
- 3013343038
- 3005974404
- 2436986
- 3018249917
- 3030515618
- 3004905070
- 3015978392
- 9612468
- 9612618
- 3018252381
- 3034729565
- 3002808149
- 3013546336
- 8010711
- 3013376795
- 3027481489
- 3009312656
- 3004884150
- 2082832
- 2424472
- 3034729999
- 2023817
- 3039433962
- 3015194291
- 3008190898
- 1725006
- 3013102320
- 3013934196
- 3040605150
- 3014980456
- 1718912
- 3031606428
- 3006223010
- 3018411778
- 3012494290
- 3009727738
- 3010002722
- 2433919
- 3007518500
- 3031595584
- 3008383146
- 3031841433
- 3025436468
- 3017619362
Source Documents#
Other 510(k) Records For Product Code EIH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K250063 | ARENA Star, Galaxy Star | Arum Dentistry Co., Ltd. | 2025-07-10 |
Legacy Summary#
summary
FDA Review#
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