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TL Implant

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref 033.611S

by Institut Straumann AG

Identity

Trade Name
TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS FDA UDI
Generic Name
Screw endosteal dental implant, two-piece FDA UDI
Device Name
TL Implant EUDAMED
Standard Plus Implant, D 4.8mm WN, SLActive® 8mm, Roxolid®, Loxim™ FDA UDI
Model / Reference
033.611S EUDAMED
SLActive Roxolid TL FDA UDI
Description
Standard Plus Implant, D 4.8mm WN, SLActive® 8mm, Roxolid®, Loxim™ FDA UDI

Identifiers

Catalog Number
033.611S FDA UDI
Primary DI / UDI-DI
07630031716255 EUDAMEDFDA UDI
Basic UDI-DI
0763003170058QZ EUDAMED
510(k) Number
K122855 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 — 8 Millimeter FDA UDI

TL 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

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Manufacturer

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

Sources (2)

  • EUDAMED def5b98b-8de8-4769-bd38-12b76dae3500 61 fields · synced Jul 14, 2026
  • FDA UDI 7bbd4cb3-0cb7-40a7-8b6a-3b044858e20d 38 fields · synced May 30, 2026