Identity
- Trade Name
- SPI VARIO FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Prosthetic EUDAMED
- Model / Reference
- 2.03.404 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640156476224 EUDAMEDFDA UDI
- Basic UDI-DI
- 7640182643402031223266WH EUDAMED
- 510(k) Number
- K031747 FDA UDI
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
Manufacturing Date
No
Category: Dental implant suprastructure, permanent, preformed
Spi Vario by Thommen Medical AG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, permanent, preformed.
- SPARE CAST. SLEEVE FOR — SWEDEN & MARTINA INC · Class II
- HS/HG Prosthetic System — OSSTEM IMPLANT Co., Ltd. · Class II
- DESS dental smart solutions — TERRATS MEDICAL SL. · Class II
- Diamodent — Diamodent · Class II
- Cemented Abutment — POINTIMPLANT Co., Ltd. · Class II
- GS System — OSSTEM IMPLANT Co., Ltd. · Class II
- Temporary Abutment — Cybermed Inc. · Class II
- EZ Post — Megagen Implant Co. Ltd · Class II
Cleared under the same submission
K031747 also covers:
- Gingiva former (4-lobe), PF 4.5, H 5.7 mm — Thommen Medical AG
- Gingiva former (4-lobe), PF 5.0, H 5.7 mm — Thommen Medical AG
- Gingiva former (4-lobe), narrow, PF 3.5, H 4.5 mm — Thommen Medical AG
- Gingiva former (4-lobe), narrow, PF 4.0, H 7.0 mm — Thommen Medical AG
- Gingiva former (4-lobe), narrow, PF 4.5, H 3.2 mm — Thommen Medical AG
- Gingiva former (4-lobe), narrow, PF 4.5, H 5.7 mm — Thommen Medical AG
- Gingiva former (4-lobe), narrow, PF 5.0, H 2.0 mm — Thommen Medical AG
- Gingiva former (4-lobe), narrow, PF 5.0, H 3.2 mm — Thommen Medical AG
- Gingiva former (4-lobe), narrow, PF 5.0, H 4.5 mm — Thommen Medical AG
- Gingiva former (4-lobe), narrow, PF 5.0, H 7.0 mm — Thommen Medical AG
- Gingiva former (4-lobe), narrow, PF 6.0, H 3.2 mm — Thommen Medical AG
- Gingiva former (4-lobe), narrow, PF 6.0, H 4.5 mm — Thommen Medical AG
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Thommen Medical AG
Sources (2)
- FDA UDI 54147f29-d5da-474d-a1d3-9cf07f916cfb 33 fields · synced Oct 7, 2026
- EUDAMED b089978b-23b8-4ded-94fd-6b6e0dbb034e 61 fields · synced Oct 7, 2026