SPI System Dental Implants
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- SPI ELEMENT INICELL FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- Dental implants EUDAMED
- Model / Reference
- 4.23.113 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640156471304 EUDAMEDFDA UDI
- Basic UDI-DI
- 7640156473101032123201TK EUDAMED
- FDA Product Code
- DZE FDA 510(k)FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Screw endosteal dental implant, two-piece FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 872.3640 FDA 510(k)
- Regulation Number
- 872.3640 FDA 510(k)FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
The SPI System Dental Implants are titanium dental implants designed for osseointegration in the alveolar bone to support single-tooth or multi-tooth prosthetics. Classified under the product code DZE, these implants are intended for use in dental restoration procedures, providing a stable foundation for crowns, bridges, or dentures.
These implants are supplied sterile and intended for single-use, requiring surgical placement by a trained dental professional. The system is authorized under FDA 510K clearance and MDR compliance, with a traditional review pathway. Storage and handling must adhere to sterile medical device protocols to ensure integrity before use.
Frequently asked questions
Are these dental implants designed for use in both single-tooth and multi-tooth restorations, and how do they achieve stability?
Yes, the SPI System Dental Implants are specifically designed for both single-tooth and multi-tooth prosthetics. They achieve stability through osseointegration, a process where the titanium implant integrates directly with the patient’s alveolar bone, creating a strong and durable foundation for crowns, bridges, or dentures.
How should the SPI System Dental Implants be stored and handled to maintain sterility before use?
The SPI System Dental Implants are supplied sterile and must be stored and handled according to sterile medical device protocols. This ensures the integrity of the implant until surgical placement by a trained dental professional, preventing contamination or damage.
Are these implants intended for single-use only, and what does that mean for a dental practice?
Yes, the SPI System Dental Implants are intended for single-use only. This means each implant is designed for one surgical procedure and should not be reused, reducing the risk of infection and ensuring patient safety. Practices must manage inventory accordingly to avoid cross-contamination.
What regulatory pathways have been followed for the SPI System Dental Implants, and how does this affect their use?
The SPI System Dental Implants have undergone FDA 510(k) clearance through a traditional review pathway and comply with MDR (Medical Device Regulation) standards. This means they have been evaluated for safety and effectiveness by regulatory authorities, ensuring they meet established performance criteria before use in dental restoration procedures.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K072649 | Class II | Active |
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Manufacturer
- Manufacturer
- Thommen Medical AG
Sources (3)
- FDA 510(k) K072649 24 fields · synced Oct 6, 2026
- FDA UDI 4202fa9f-57bf-4244-b283-5fa97ddd54b0 33 fields · synced May 25, 2026
- EUDAMED 3daedff5-70e5-49c0-a79e-2b819850dd59 61 fields · synced Sep 17, 2026