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BLC Implant
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 035.9514SRef 035.8310SRef 035.8306SRef 035.9312SRef 035.9508SRef 035.8318SRef 035.8314SRef 035.9512SRef 035.8816SRef 035.8308SRef 035.9206SRef 035.9516SRef 035.9708SRef 035.8814SRef 035.9210SRef 035.9506SRef 035.9410SRef 035.9208SRef 035.8516S
Identity
- Trade Name
- Straumann® BLC and TLC Implants FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- BLC Implant EUDAMEDBLC Implant, Ø 3.75mm RB, SLActive® 10mm, Roxolid® FDA UDIBLC Implant, Ø 3.75mm RB, SLActive® 8mm, Roxolid® FDA UDIBLC Implant, Ø 3.75mm RB, SLActive® 6mm, Roxolid® FDA UDIBLC Implant, Ø 6.5mm WB, SLA 14mm, Roxolid FDA UDIBLC Implant, Ø 4.5mm WB, SLActive® 10mm, Roxolid® FDA UDIBLC Implant, Ø 5.5mm WB, SLActive® 8mm, Roxolid® FDA UDI
- Model / Reference
- 035.9514S EUDAMED035.8310S EUDAMED035.8306S EUDAMED035.9312S EUDAMED035.9508S EUDAMED035.8318S EUDAMED035.8314S EUDAMED035.9512S EUDAMED035.8816S EUDAMED035.8308S EUDAMED035.9206S EUDAMED035.9516S EUDAMED035.9708S EUDAMED035.8814S EUDAMED035.9210S EUDAMED035.9506S EUDAMED035.9410S EUDAMED035.9208S EUDAMED035.8516S EUDAMEDSLActive Roxolid BL FDA UDISLA Roxolid BL FDA UDI
- Description
- BLC Implant, Ø 3.75mm RB, SLActive® 10mm, Roxolid® FDA UDIBLC Implant, Ø 3.75mm RB, SLActive® 8mm, Roxolid® FDA UDIBLC Implant, Ø 3.75mm RB, SLActive® 6mm, Roxolid® FDA UDIBLC Implant, Ø 6.5mm WB, SLA 14mm, Roxolid FDA UDIBLC Implant, Ø 4.5mm WB, SLActive® 10mm, Roxolid® FDA UDIBLC Implant, Ø 5.5mm WB, SLActive® 8mm, Roxolid® FDA UDI
Identifiers
- Catalog Number
- 035.9210S FDA UDI035.9208S FDA UDI035.9206S FDA UDI035.8814S FDA UDI035.9410S FDA UDI035.9708S FDA UDI
- Primary DI / UDI-DI
- 07630031780171 EUDAMED07630031780225 EUDAMED07630031780201 EUDAMED07630031780096 EUDAMED07630031780140 EUDAMED07630031780263 EUDAMED07630031780249 EUDAMED07630031780164 EUDAMED07630031764652 EUDAMED07630031780218 EUDAMED07630031764270 EUDAMEDFDA UDI07630031764294 EUDAMEDFDA UDI07630031764287 EUDAMEDFDA UDI07630031764645 EUDAMEDFDA UDI07630031764430 EUDAMEDFDA UDI07630031764553 EUDAMEDFDA UDI07630031780188 EUDAMED07630031780133 EUDAMED07630031780324 EUDAMED
- Basic UDI-DI
- 0763003170107QM EUDAMED
- 510(k) Number
- K230108 FDA UDI
- 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
Yes
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 3.75 Millimeter FDA UDILength — 10 Millimeter FDA UDILength — 8 Millimeter FDA UDILength — 6 Millimeter FDA UDIOuter Diameter — 6.5 Millimeter FDA UDILength — 14 Millimeter FDA UDIOuter Diameter — 4.5 Millimeter FDA UDIOuter Diameter — 5.5 Millimeter FDA UDI
BLC 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 | 0763003170107QM | 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 (25)
- EUDAMED d7b1137b-c04b-48d6-adc3-85ee8652db56 61 fields · synced Jul 30, 2026
- EUDAMED 981d0dd9-5715-4f95-907f-e19bc71c80d2 61 fields · synced May 16, 2026
- EUDAMED 0cd68e72-aff9-4e78-aef3-a92c4c992b06 61 fields · synced May 17, 2026
- EUDAMED 78db4933-9919-4bf0-8336-2c1db2a636b6 61 fields · synced May 17, 2026
- EUDAMED 2cdd2664-d0d8-4cb1-aa92-f351283f36a6 61 fields · synced May 17, 2026
- EUDAMED f4c49b1f-4b13-42ca-bf45-6a7b35bda1e9 61 fields · synced May 17, 2026
- EUDAMED 3668e3da-e61b-48c6-93ae-0bb785fca583 61 fields · synced May 17, 2026
- EUDAMED 24ea7a05-88b8-43cd-ad98-ec33c4e2db63 61 fields · synced May 18, 2026
- EUDAMED 0153c9e5-0831-4dec-9d11-c383c449b43f 61 fields · synced May 18, 2026
- EUDAMED 7665e678-4a72-4b4c-89e3-d6da2382407d 61 fields · synced May 18, 2026
- EUDAMED bf9bbcad-99ca-4565-9c72-5776273c576e 61 fields · synced May 18, 2026
- FDA UDI 6d177ff9-9d7f-4c52-a822-b8d2eb8f8d8f 38 fields · synced May 26, 2026
- FDA UDI c3317702-d4ae-422a-83b9-a5e290e52f6a 38 fields · synced May 29, 2026
- FDA UDI e735a00d-2726-4533-8ed7-6cda58456fd0 38 fields · synced May 29, 2026
- FDA UDI e73a4a19-38f5-4b83-9a09-5c3e6e0a3c54 37 fields · synced May 30, 2026
- FDA UDI cc78e81e-2b2d-4df7-b8bd-577a73dd7744 38 fields · synced May 30, 2026
- FDA UDI 08cae542-f381-40c0-85e3-35c2d68e9ed7 38 fields · synced May 30, 2026
- EUDAMED a830956f-dc94-44d4-9d5a-da665528f36d 61 fields · synced Jul 9, 2026
- EUDAMED c48e8a0d-6892-4f8d-9454-eb91e173f630 61 fields · synced Jul 10, 2026
- EUDAMED a3ca35bb-14d6-47ce-bbe8-c13a905ecb0a 61 fields · synced Jul 12, 2026
- EUDAMED 2d0653f9-7747-472d-92b0-357c686d4437 61 fields · synced Jul 12, 2026
- EUDAMED e7d8f258-795b-4b0f-b65e-fc3456a8fb18 61 fields · synced Jul 17, 2026
- EUDAMED 0d031a2c-eec1-43eb-8332-d2409f04233b 61 fields · synced Jul 21, 2026
- EUDAMED b643b049-5a72-45b2-a21a-33d4180ca2d3 61 fields · synced Jul 23, 2026
- EUDAMED a651175e-ae29-4e96-8c22-3bf33939f97a 61 fields · synced Jul 30, 2026