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Bl, 04.1 Mm Rc, Slactive 8mm, Tizr And 10mm, 12, 14mm

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 021.6310

by Institut Straumann SA

Identity

Trade Name
BL, 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 EUDAMED
Bone Level Implant D 4.8mm RC, SLActive® 10mm, Roxolid® Loxim™ FDA UDI
Model / Reference
021.6310 EUDAMED
SLActive Roxolid BL FDA UDI
Description
Bone Level Implant D 4.8mm RC, SLActive® 10mm, Roxolid® Loxim™ FDA UDI

Identifiers

Catalog Number
021.6310 FDA UDI
Primary DI / UDI-DI
07630031707260 EUDAMEDFDA UDI
Basic UDI-DI
0763003170115QL EUDAMED
510(k) Number
K121131 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 EUDAMED
Class 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
Outer Diameter — 4.8 Millimeter FDA UDI
Length — 10 Millimeter FDA UDI

Bl, 04.1 Mm Rc, Slactive 8mm, Tizr And 10mm, 12, 14mm by Institut Straumann SA — Class II — FDA UDI — listed in FDA GUDID, EUDAMED

Cleared under the same submission

K121131 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Institut Straumann SA

Sources (2)

  • FDA UDI 8b6cdb1d-b406-42b2-b992-5dcad4673021 38 fields · synced Oct 7, 2026
  • EUDAMED 5443ab16-dfbf-4d1d-8f36-354d68a51a03 61 fields · synced Jul 18, 2026