510(k) K011428
- Device
- TRICERAM
- Applicant
- DENTAURUM, INC.
- 510(k) number
- K011428
- Product code
- EIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-06-05
- Date received
- 2001-05-09
- 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
- No
Applicant Contact#
- Contact
- THOMAS J ANDERSON
- Address
- 10 Pheasant Run Newtown PA US 18940 18940
FDA Registration Numbers#
- 1000426619
- 3009300369
- 3012441963
- 3038718579
- 9611385
- 3024046877
- 3008582406
- 2523320
- 2244842
- 3005942449
- 1000625496
- 3010905160
- 3015332784
- 3010127342
- 9681199
- 8010711
- 3004362235
- 3013343038
- 3033848620
- 3010564008
- 3006110126
- 1000118628
- 2082832
- 3039433962
- 3024185724
- 3031606428
- 3008320092
- 9612468
- 3009312656
- 3017674095
- 3006235664
- 2647456
- 3002808149
- 2436986
- 1410097
- 3027341558
- 3030464310
- 3002807050
- 3009081830
- 3009409473
- 3029968429
- 3008190898
- 3011649314
- 3004884150
- 3031605796
- 3034729999
- 3009727738
- 3008754429
- 3038715999
- 3011824442
- 3019784699
- 3030536692
- 3025436468
- 9612300
- 3008912871
- 3000219976
- 3005554774
- 3034729565
- 3040605150
- 3022082678
- 3022068322
- 1064583
- 3031595584
- 3035693034
- 3012421607
- 2424472
- 3013934196
- 3003775534
- 3014311922
- 3007738736
- 3010002722
- 3030515618
- 3009482106
- 3003449480
- 2916735
- 3042272797
- 1718912
- 8031058
- 9614977
Source Documents#
Other 510(k) Records For Product Code EIH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K250826 | Multi M Series | Dmax Co., Ltd. | 2025-06-12 |
| K251084 | zirkon; structure; LFU shades, stains and glazes | Estetic Ceram AG | 2025-06-05 |
| K250673 | CERABIEN MiLai | Kuraray Noritake Dental, Inc. | 2025-05-29 |
| K250534 | Biomic Color Opaque | Aidite (Qinhuangdao) Technology Co., Ltd. | 2025-05-20 |
| K250393 | ZircaGlow & ZircaGlow HT Zirconia | United Zirconia | 2025-05-12 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases