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Bone Level Implant
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 021.2614Ref 021.4512Ref 021.2608Ref 021.6310Ref 021.2508Ref 021.6610
Identity
- Trade Name
- STRAUMANN DENTAL IMPLANT SYSTEM FDA UDIStraumann® Dental Implant System Roxolid® SLA Impl. FDA UDIBL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- Bone Level Implant EUDAMEDBone Level Implant, D 3.3mm NC, SLA® 8mm, Ti, Loxim™ FDA UDIBone Level Implant, D 3.3mm NC, SLA® 14mm, Ti, Loxim™ FDA UDIBone Level Implant, D 4.8mm RC, SLA® 10mm, Ti, Loxim™ FDA UDIBone Level Implant, D 3.3mm NC, SLA® 8mm, Roxolid®, Loxim™ FDA UDIBone Level Implant, D 4.1mm RC, SLA® 12mm, Roxolid®, Loxim™ FDA UDIBone Level Implant D 4.8mm RC, SLActive® 10mm, Roxolid® Loxim™ FDA UDI
- Model / Reference
- 021.2614 EUDAMED021.4512 EUDAMED021.2608 EUDAMED021.6310 EUDAMED021.2508 EUDAMED021.6610 EUDAMEDSLA Titanium BL FDA UDISLA Roxolid BL FDA UDISLActive Roxolid BL FDA UDI
- Description
- Bone Level Implant, D 3.3mm NC, SLA® 8mm, Ti, Loxim™ FDA UDIBone Level Implant, D 3.3mm NC, SLA® 14mm, Ti, Loxim™ FDA UDIBone Level Implant, D 4.8mm RC, SLA® 10mm, Ti, Loxim™ FDA UDIBone Level Implant, D 3.3mm NC, SLA® 8mm, Roxolid®, Loxim™ FDA UDIBone Level Implant, D 4.1mm RC, SLA® 12mm, Roxolid®, Loxim™ FDA UDIBone Level Implant D 4.8mm RC, SLActive® 10mm, Roxolid® Loxim™ FDA UDI
Identifiers
- Catalog Number
- 021.2608 FDA UDI021.2614 FDA UDI021.6610 FDA UDI021.2508 FDA UDI021.4512 FDA UDI021.6310 FDA UDI
- Primary DI / UDI-DI
- 07630031706607 EUDAMEDFDA UDI07630031706577 EUDAMEDFDA UDI07630031707406 EUDAMEDFDA UDI07630031706539 EUDAMEDFDA UDI07630031706966 EUDAMEDFDA UDI07630031707260 EUDAMEDFDA UDI
- Basic UDI-DI
- 0763003170115QL 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
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 8 Millimeter FDA UDIOuter Diameter — 3.3 Millimeter FDA UDILength — 14 Millimeter FDA UDILength — 10 Millimeter FDA UDIOuter Diameter — 4.8 Millimeter FDA UDILength — 12 Millimeter FDA UDIOuter Diameter — 4.1 Millimeter FDA UDI
Bone Level Implant by Institut Straumann AG — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0763003170115QL | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Institut Straumann AG
- EUDAMED SRN
- CH-MF-000009933
- Authorised Representative
- Etkon GmbH DE-AR-000009335
Sources (12)
- EUDAMED 46fa0a53-aa19-4131-887c-086d0881e49e 61 fields · synced Jul 31, 2026
- FDA UDI 9187fcd7-f8eb-42de-a56f-48f04c26579f 38 fields · synced May 29, 2026
- FDA UDI 7069bd28-b214-4624-9235-6562cbf87598 38 fields · synced May 30, 2026
- FDA UDI 61e09802-ccef-40d5-a2a0-711915d003da 38 fields · synced May 30, 2026
- FDA UDI 9902fc91-631b-4226-b963-850202825632 38 fields · synced May 30, 2026
- FDA UDI 27a6fb40-c874-406a-9424-c11c3c611037 38 fields · synced May 30, 2026
- FDA UDI 8b6cdb1d-b406-42b2-b992-5dcad4673021 38 fields · synced May 30, 2026
- EUDAMED cfe255e2-b9db-4178-bfb1-a85b643b2d95 61 fields · synced Jul 8, 2026
- EUDAMED 72291b64-5ae9-4fb1-9f2c-d97497fb3d2d 61 fields · synced Jul 17, 2026
- EUDAMED 5443ab16-dfbf-4d1d-8f36-354d68a51a03 61 fields · synced Jul 18, 2026
- EUDAMED 54d07f43-9304-49df-9462-5060f289e3e9 61 fields · synced Jul 19, 2026
- EUDAMED 1f17df79-a41b-4493-975b-39d0b755f7ca 61 fields · synced Jul 31, 2026