DCMhotbond zircon
FDA 510(k) clearance K253191 · decided 2026-05-21
Clearance details
- K-number
- K253191
- Device name
- DCMhotbond zircon
- Applicant
- Dental Creativ Management GmbH
- Decision
- Substantially Equivalent
- Date received
- 2025-09-26
- Decision date
- 2026-05-21
- Days to decision
- 237 days
- Clearance type
- Traditional
- Product code
- EIH
- Device class
- 2
- Regulation number
- 872.6660
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mecklenburg-Vorpommerin, DE
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
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| 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 |
| BruxZir® NOW (K252446) | Prismatik Dentalcraft, Inc. | 2025-09-03 |
Recalls involving this device
No recalls on record reference this clearance.