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Sign in to claim this brandDoceram Medical Ceramics GmbH
US
Last updated May 27, 2026
What Doceram Medical Ceramics GmbH makes
Doceram Medical Ceramics GmbH specializes in ceramic materials used for dental appliance fabrication, providing a range of products under the brand Nacera. These materials are designed for dental restorations, including crowns, bridges, and other fixed prosthetics, offering biocompatible and durable solutions for dental applications.
The company’s portfolio is regulated under Class II medical devices in the US, with products authorised via 510(k) premarket notifications and listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Doceram Medical Ceramics GmbH manufacture?
Doceram Medical Ceramics GmbH specializes in ceramic materials used for dental appliance fabrication. Their primary focus is on dental appliance fabrication materials, specifically ceramics, which are used for dental restorations like crowns, bridges, and other fixed prosthetics. These materials are designed to be biocompatible and durable for long-term use in dental applications.
Where is Doceram Medical Ceramics GmbH based?
Doceram Medical Ceramics GmbH operates from the United States. The company’s headquarters and manufacturing operations are located within the country, though specific regional offices or production sites are not detailed in the available information.
Which regulatory registries list Doceram Medical Ceramics GmbH’s devices?
Doceram Medical Ceramics GmbH’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries confirm the company’s products have undergone the necessary regulatory pathways for authorisation in the US, including 510(k) clearance for their Class II devices.
How are Doceram Medical Ceramics GmbH’s devices classified in the US?
Doceram Medical Ceramics GmbH’s devices fall under Class II classification in the US regulatory framework. This classification applies to dental ceramics used in restorations, which are considered moderate-risk devices requiring premarket notification (510(k)) to demonstrate substantial equivalence to a legally marketed predicate device before being authorised for sale.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- dentaldirekt.de
- —
- —
- [email protected]
- Phone
- +495225863190
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 537713567
Catalogue (473)
Page 2 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Nacera | Pearl Shaded 0M3 | FDA UDI | Class II | Active |
| Nacera | Pearl Shaded C2 | FDA UDI | Class II | Active |
| Nacera | Pearl Shaded B3 | FDA UDI | Class II | Active |
| Nacera | Pearl Shaded A2 | FDA UDI | Class II | Active |
| Nacera | Pearl Natural C2 | FDA UDI | Class II | Active |
| Nacera | Pearl 1,5 | FDA UDI | Class II | Unknown |
| Nacera | Pearl 1 for Amann Girrbach | FDA UDI | Class II | Unknown |
| Nacera | Pearl 2,5 | FDA UDI | Class II | Unknown |
| Nacera | Pearl 5 | FDA UDI | Class II | Unknown |
| Nacera | Pearl Shaded A3,5 | FDA UDI | Class II | Active |
| Nacera | Pearl Natural A2 | FDA UDI | Class II | Active |
| Nacera | Hybrid Bleach 2 Block M | FDA UDI | Class II | Unknown |
| Nacera | Pearl Shaded B2 | FDA UDI | Class II | Active |
| Nacera | Pearl Shaded A2 | FDA UDI | Class II | Active |
| Nacera | Hybrid A3 Block S | FDA UDI | Class II | Unknown |
| Nacera | Pearl Multi-Shade A | FDA UDI | Class II | Unknown |
| Nacera | Pearl Multi-Shade B | FDA UDI | Class II | Unknown |
| Nacera | Pearl Shaded A4 | FDA UDI | Class II | Active |
| Nacera | Hybrid A1 Disc | FDA UDI | Class II | Unknown |
| Nacera | Pearl 1 Zirkonzahn 95 | FDA UDI | Class II | Unknown |
| Nacera | Pearl Shaded A2 | FDA UDI | Class II | Active |
| Nacera | Pearl Natural B1 | FDA UDI | Class II | Active |
| Nacera | Pearl Shaded D4 | FDA UDI | Class II | Active |
| Nacera | Pearl 1 Zirkonzahn 95 | FDA UDI | Class II | Unknown |
| Nacera | Classic Liquid Body A3 | FDA UDI | Class II | Unknown |
| Nacera | Pearl Shaded OM2 | FDA UDI | Class II | Active |
| Nacera | Pearl Shaded B4 | FDA UDI | Class II | Active |
| Nacera | Pearl 1 | FDA UDI | Class II | Unknown |
| Nacera | Pearl Shaded D4 | FDA UDI | Class II | Active |
| Nacera | Pearl Shaded B3 | FDA UDI | Class II | Active |
| Nacera | Pearl Shaded OM2 | FDA UDI | Class II | Active |
| Nacera | Hybrid A2 Disc | FDA UDI | Class II | Unknown |
| Nacera | Shell 3 | FDA UDI | Class II | Unknown |
| Nacera | Pearl Shaded A4 | FDA UDI | Class II | Active |
| Nacera | Pearl Natural Stellar white | FDA UDI | Class II | Active |
| Nacera | Pearl Shaded A3 | FDA UDI | Class II | Active |
| Nacera | Pearl 3 | FDA UDI | Class II | Unknown |
| Nacera | Classic Liquid Balancer | FDA UDI | Class II | Unknown |
| Nacera | Pearl 2 | FDA UDI | Class II | Unknown |
| Nacera | Classic Liquid Body C1 | FDA UDI | Class II | Unknown |
| Nacera | Pearl Shaded B1 | FDA UDI | Class II | Active |
| Nacera | Pearl Shaded C1 | FDA UDI | Class II | Active |
| Nacera | Classic Liquid Body C1 | FDA UDI | Class II | Unknown |
| Nacera | Pearl Natural Stellar white | FDA UDI | Class II | Active |
| Nacera | Hybrid C2 Block M | FDA UDI | Class II | Unknown |
| Nacera | Pearl 1 Zirkonzahn 95 | FDA UDI | Class II | Unknown |
| Nacera | Pearl Shaded B2 | FDA UDI | Class II | Active |
| Nacera | Pearl Shaded C1 | FDA UDI | Class II | Active |
| Nacera | Pearl Shaded B4 | FDA UDI | Class II | Active |
| Nacera | Pearl Q³ Multi-Shade A-Dark | FDA UDI | Class II | Unknown |
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