TSX® Immediate Molar Implant
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- TSX® Immediate Molar Implant EUDAMEDFDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- Friction-Fit Implants EUDAMEDTSX® Immediate Molar Implant, 7mmD, 10mmL FDA UDI
- Model / Reference
- TSXIM7D10L EUDAMEDFDA UDI
- Description
- TSX® Immediate Molar Implant, 7mmD, 10mmL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00844868047674 EUDAMEDFDA UDI
- Basic UDI-DI
- 844868B9HD EUDAMED
- FDA Product Code
- DZE 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 UDI
- Regulation Number
- 872.3640 FDA UDI
- Market of Registration
- Spain EUDAMED
- 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
Yes
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
Dimensions & Sizes
- Size
- Length — 10 Millimeter FDA UDI
Category: Screw endosteal dental implant, two-piece
TSX® Immediate Molar Implant by Biomet 3i, Llc — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Screw endosteal dental implant, two-piece.
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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 |
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Manufacturer
- Manufacturer
- Biomet 3i, Llc
Sources (2)
- FDA UDI c50955f9-1e4e-401a-9636-79c6534ebf3d 34 fields · synced Sep 17, 2026
- EUDAMED 3990e22e-d650-43e9-b163-794bcd79a375 61 fields · synced Sep 17, 2026