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BLX Implant

EUDAMEDFDA 510(k)FDA UDI

Class IIb (EU MDR)

Ref 061.4324510(k) K173961Ref 061.4512Ref 061.5316Ref 061.5308Ref 061.3314Ref 061.9510Ref 061.4314Ref 061.3516

by Institut Straumann AG

Identity

Trade Name
Straumann BLX Line Extension - Implants, SRAs And Anatomic Abutments FDA UDI
Straumann BLX Ø3.5 mm Implants FDA UDI
Straumann BLX Implant System FDA UDI
Generic Name
Screw endosteal dental implant, two-piece FDA UDI
Device Name
BLX Implant EUDAMED
BLX Implant, Ø 3.75mm RB, SLA® 12mm, Roxolid® FDA UDI
BLX Implant, Ø 3.5mm RB, SLActive® 14mm, Roxolid® FDA UDI
BLX Implant, Ø 4.0mm RB, SLActive® 16mm, Roxolid® FDA UDI
BLX Implant, Ø 6.5mm WB, SLA® 10mm, Roxolid® FDA UDI
BLX Implant, Ø 4.0mm RB, SLActive® 8mm, Roxolid® FDA UDI
BLX Ø3.75 RB, SLActive® 14mm, RXD FDA UDI
BLX Implant, Ø 3.5mm RB, SLA® 16mm, Roxolid® FDA UDI
Model / Reference
061.4324 EUDAMED
061.4512 EUDAMED
061.5316 EUDAMED
061.5308 EUDAMED
061.3314 EUDAMED
061.9510 EUDAMED
061.4314 EUDAMED
061.3516 EUDAMED
SLA Roxolid BL FDA UDI
SLActive Roxolid BL FDA UDI
Description
BLX Implant, Ø 3.75mm RB, SLA® 12mm, Roxolid® FDA UDI
BLX Implant, Ø 3.5mm RB, SLActive® 14mm, Roxolid® FDA UDI
BLX Implant, Ø 4.0mm RB, SLActive® 16mm, Roxolid® FDA UDI
BLX Implant, Ø 6.5mm WB, SLA® 10mm, Roxolid® FDA UDI
BLX Implant, Ø 4.0mm RB, SLActive® 8mm, Roxolid® FDA UDI
BLX Ø3.75 RB, SLActive® 14mm, RXD FDA UDI
BLX Implant, Ø 3.5mm RB, SLA® 16mm, Roxolid® FDA UDI

Identifiers

Catalog Number
061.4512 FDA UDI
061.3314 FDA UDI
061.5316 FDA UDI
061.9510 FDA UDI
061.5308 FDA UDI
061.4314 FDA UDI
061.3516 FDA UDI
Primary DI / UDI-DI
07630031743428 EUDAMED
07630031743466 EUDAMEDFDA UDI
07630031743305 EUDAMEDFDA UDI
07630031743558 EUDAMEDFDA UDI
07630031743916 EUDAMEDFDA UDI
07630031743510 EUDAMEDFDA UDI
07630031736529 EUDAMEDFDA UDI
07630031743381 EUDAMEDFDA UDI
Basic UDI-DI
0763003170069R6 EUDAMED
510(k) Number
K173961 FDA 510(k)
K191256 FDA UDI
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 EUDAMED
Class 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

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 UDIFDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Length — 12 Millimeter FDA UDI
Outer Diameter — 3.75 Millimeter FDA UDI
Length — 14 Millimeter FDA UDI
Outer Diameter — 3.5 Millimeter FDA UDI
Outer Diameter — 4 Millimeter FDA UDI
Length — 16 Millimeter FDA UDI
Outer Diameter — 6.5 Millimeter FDA UDI
Length — 10 Millimeter FDA UDI
Length — 8 Millimeter FDA UDI

BLX Implant by Institut Straumann AG — Class IIb — FDA_510K, MDR — listed in EUDAMED, FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Institut Straumann AG
EUDAMED SRN
CH-MF-000009933
Authorised Representative
Etkon GmbH DE-AR-000009335

Sources (16)

  • EUDAMED eb7f98f0-d1a4-4f4c-b9ab-58add8ecb17c 61 fields · synced Jul 30, 2026
  • FDA 510(k) K173961 24 fields · synced May 18, 2026
  • FDA UDI 0a9d977b-214e-4706-8273-3930ecdd79a7 37 fields · synced May 29, 2026
  • FDA UDI f668dfba-5d22-4fda-865c-a34ce513ed01 38 fields · synced May 30, 2026
  • FDA UDI 228a7408-f346-4bd4-b514-f8bf6509d84b 37 fields · synced May 30, 2026
  • FDA UDI 896a6641-c287-45bd-9da8-285f4394b5ac 37 fields · synced May 30, 2026
  • FDA UDI e74d30aa-cb00-483d-affa-a29b9ce105b7 37 fields · synced May 30, 2026
  • FDA UDI c3ddb6a2-df7e-4544-90c2-0fe3500db2db 37 fields · synced May 30, 2026
  • FDA UDI 483768ee-ef88-4034-b1e7-091bbac298df 38 fields · synced May 30, 2026
  • EUDAMED 0014602c-ee92-406c-8f4c-8122c3dd7ab5 61 fields · synced Jul 10, 2026
  • EUDAMED f759ebce-acfd-4f32-b6c8-780a134523d6 61 fields · synced Jul 10, 2026
  • EUDAMED 4ce93a20-703c-4551-8be9-f302336425e1 61 fields · synced Jul 13, 2026
  • EUDAMED 2fb8b9ad-5987-4b51-ae6d-b438ff56af9e 61 fields · synced Jul 22, 2026
  • EUDAMED f8f06a0b-3c47-4587-8a86-576015860a1c 61 fields · synced Jul 25, 2026
  • EUDAMED 43781d3e-af85-4da3-81c0-197aa2b43302 61 fields · synced Jul 27, 2026
  • EUDAMED 311d56fc-5800-4427-82a3-18a215e36614 61 fields · synced Jul 30, 2026