DCMhotbond zircon— 510(k) K253191
Substantially EquivalentDental Creativ Management GmbH
FDA 510(k) clearance K253191 for DCMhotbond zircon, Substantially Equivalent on 2026-05-21. Applicant: Dental Creativ Management GmbH. Device class: 2.
Summary
Dental Creativ Management filed DCMhotbond zircon under EIH, porcelain powders.
Class II, 21 CFR 872.6660. Dental is both the classification panel and the review panel. It was a Traditional 510(k).
The record gives the location as Mecklenburg-Vorpommerin, Germany. The decision came 237 calendar days after receipt (September 26, 2025 to May 21, 2026).
Clearance details
- Applicant
- Dental Creativ Management GmbH
- Product code
- Product code EIH
- Device class
- Class 2
- Regulation
- 21 CFR 872.6660
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mecklenburg-Vorpommerin, DE
Recent devices under product code EIH
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