510(k) K142987
- Device
- DD Bio Z, DD Bio ZX(square), DD BioZX(square) Color
- Applicant
- DENTAL DIREKT OF AMERIKA UG (HAFTUNGSBESCHRAENKT)
- 510(k) number
- K142987
- Product code
- EIH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-02-11
- Date received
- 2014-10-16
- 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
- Gerhard de Boer
- Address
- Pappelweg 6 Spenge DE 32139 32139
FDA Registration Numbers#
- 3022082678
- 1410097
- 3040605150
- 3005942449
- 3023272670
- 9612352
- 2916735
- 3039433962
- 3017674095
- 3031605796
- 1420052
- 3013136463
- 3008564629
- 3015978392
- 1420089
- 3017619362
- 3031841433
- 3009727738
- 3019596325
- 3030515618
- 3018249917
- 3034729565
- 3025436468
- 3009643402
- 3014945384
- 1064583
- 3014311922
- 3009482106
- 3009300369
- 9681531
- 3012187973
- 3002889488
- 3008383146
- 3015194291
- 2436986
- 3030464310
- 3012354669
- 3031595584
- 3018252381
- 3012441963
- 9613953
- 3014980456
- 3002807050
- 3003449480
- 2023129
- 3008912871
- 3018411778
- 3035983708
- 3004884150
- 3007160911
- 3013513796
- 3020611371
- 3003775534
- 1000118628
- 2424472
- 3031886796
- 3008582406
- 3015332784
- 3038718579
- 9681199
- 3024185724
- 3010002722
- 3034244245
- 3004491043
- 3011221537
- 3008792854
- 3030621102
- 3008754429
- 3042370495
- 3009409473
- 9613348
- 3038715999
- 3006235664
- 3009081830
- 3004905070
- 3022068322
- 3004362235
- 3008347275
- 3010564008
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#
summary
FDA Review#
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