DUCERAM PLUS CERAMIC SYSTEM
FDA 510(k) clearance K040420 · decided 2004-03-18
Clearance details
- K-number
- K040420
- Device name
- DUCERAM PLUS CERAMIC SYSTEM
- Applicant
- Dentsply Intl.
- Decision
- Substantially Equivalent
- Date received
- 2004-02-18
- Decision date
- 2004-03-18
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- EIH
- Device class
- 2
- Regulation number
- 872.6660
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- York, PA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| DCMhotbond zircon (K253191) | Dental Creativ Management GmbH | 2026-05-21 |
| Eternal Art Porcelain Powders (K260067) | Shandong Huge Dental Material Corporation | 2026-04-09 |
| Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (K260370) | Bloomden Bioceramics (HuNan) Co., Ltd. | 2026-03-30 |
| IPS e.max Zirconia (K253953) | Ivoclar Vivadent, Inc. | 2026-03-10 |
| BruxZir® Shaded 16 PLUS (K254283) | Prismatik Dentalcraft, Inc. | 2026-01-30 |
| Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series (K253973) | Liaoning Upcera Co., Ltd. | 2026-01-09 |
| Glass Ceramic (K252789) | Shenzhen Xiangtong Co., Ltd. | 2025-12-08 |
Recalls involving this device
No recalls on record reference this clearance.