Prama White Implant Systems
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K180365 FDA 510(k)
- FDA Product Code
- DZE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3640 FDA 510(k)
- Regulation Number
- 872.3640 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Prama White Implant Systems is a dental implant system designed for osseointegrated restoration in the oral cavity. Classified under dental implant devices, it provides components for single crowns, bridges, and full-arch prosthetics, featuring a COLLEX ONE connection for secure prosthetic attachment. The system includes abutments with and without repositioning shoulders, allowing clinicians flexibility in prosthetic margin placement. Its design prioritises soft tissue integration and stability through internal prosthetic support collars.
The system is supplied as a reusable, non-sterile kit for clinical preparation, requiring sterilisation prior to use. Implants are intended for single-use per patient, with sizes and configurations determined by the manufacturer’s specifications. The Prama White is authorised under FDA 510(k) clearance (K180365) and MDD compliance, adhering to dental implant standards for osseointegration. Storage follows standard medical device protocols, and MRI safety is not specified. No third-party reprocessing is indicated.
Frequently asked questions
What types of dental restorations can the Prama White Implant Systems support, and how does its connection system contribute to stability?
The Prama White Implant Systems supports single crowns, bridges, and full-arch prosthetics. Its COLLEX ONE connection ensures a secure attachment for prosthetic components, while the internal prosthetic support collars enhance stability and soft tissue integration, helping to maintain long-term osseointegration.
Is the Prama White Implant System reusable, and if so, what sterilization method should be used before clinical use?
Yes, the Prama White Implant Systems is supplied as a reusable, non-sterile kit for clinical preparation. It must be sterilized prior to use following standard medical device sterilization protocols, as it is not intended for direct patient application out of the box.
Are the implants in this system single-use, and if so, how are sizes and configurations determined?
Yes, the implants themselves are intended for single-use per patient. Sizes and configurations are predefined by the manufacturer’s specifications, which clinicians can reference when selecting the appropriate components for a patient’s specific anatomical needs.
How should the Prama White Implant Systems be stored, and are there any special considerations for handling?
The system should be stored according to standard medical device protocols, ensuring it remains clean and protected from contamination. Since it is reusable and non-sterile, it must be sterilized before clinical use, and there are no third-party reprocessing recommendations provided.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Prosthetic Solutions | Prama Power, Prama W Power Sweden & Martina Spa, Home | Sweden & Martina INC
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K180365 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sweden & Martina S.p.a.
Sources (2)
- FDA 510(k) K180365 24 fields · synced Sep 20, 2026
- EUDAMED 1 fields · synced May 18, 2026