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Straumann TLX Implant System

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K200586Ref 035.2014SRef 035.0114SRef 035.0810SRef 035.2016SRef 035.0506SRef 035.0012SRef 035.2812SRef 035.3116SRef 035.1806SRef 035.0016SRef 035.1106SRef 035.0418SRef 035.2108SRef 035.3516SRef 035.3808SRef 035.1408SRef 035.2412SRef 035.3708SRef 035.3812SRef 035.0708SRef 035.3304SRef 035.3512S

by Institut Straumann AG

Identity

Trade Name
Straumann TLX Implant System FDA UDI
Generic Name
Screw endosteal dental implant, two-piece FDA UDI
Device Name
TLX Implant EUDAMED
TLX S Implant, Ø 6.5mm WT, SLA® 10mm, Roxolid® FDA UDI
TLX SP Implant, Ø 3.75mm RT, SLActive® 16mm, Roxolid® FDA UDI
TLX S Implant, Ø 4.5mm NT, SLA® 18mm, Roxolid® FDA UDI
TLX S Implant, Ø 3.75mm NT, SLA® 12mm, Roxolid® FDA UDI
TLX S Implant, Ø 3.75mm RT, SLA® 14mm, Roxolid® FDA UDI
TLX SP Implant, Ø 3.75mm RT, SLA® 8mm, Roxolid® FDA UDI
TLX S Implant, Ø 6.5mm WT, SLActive® 6mm, Roxolid® FDA UDI
TLX SP Implant, Ø 6.5mm WT, SLActive® 12mm, Roxolid® FDA UDI
TLX SP Implant, Ø 4.5mm NT, SLA® 12mm, Roxolid® FDA UDI
TLX S Implant, Ø 4.5mm NT, SLActive® 8mm, Roxolid® FDA UDI
TLX SP Implant, Ø 3.75mm NT, SLA® 16mm, Roxolid® FDA UDI
TLX SP Implant, Ø 5.5mm WT, SLActive® 8mm, Roxolid® FDA UDI
TLX SP Implant, Ø 3.75mm NT, SLA® 14mm, Roxolid® FDA UDI
TLX S Implant, Ø 4.5mm RT, SLA® 6mm, Roxolid® FDA UDI
TLX S Implant, Ø 3.75mm RT, SLActive® 6mm, Roxolid® FDA UDI
TLX SP Implant, Ø 6.5mm WT, SLA® 12mm, Roxolid® FDA UDI
TLX S Implant, Ø 5.5mm WT, SLA® 8mm, Roxolid® FDA UDI
TLX S Implant, Ø 3.75mm NT, SLA® 16mm, Roxolid® FDA UDI
TLX SP Implant, Ø 4.5mm RT, SLActive® 12mm, Roxolid® FDA UDI
TLX SP Implant, Ø 6.5mm WT, SLActive® 8mm, Roxolid® FDA UDI
TLX SP Implant, Ø 4.5mm RT, SLActive® 16mm, Roxolid® FDA UDI
Model / Reference
035.2014S EUDAMED
035.0114S EUDAMED
035.0810S EUDAMED
035.2016S EUDAMED
035.0506S EUDAMED
035.0012S EUDAMED
035.2812S EUDAMED
035.3116S EUDAMED
035.1806S EUDAMED
035.0016S EUDAMED
035.1106S EUDAMED
035.0418S EUDAMED
035.2108S EUDAMED
035.3516S EUDAMED
035.3808S EUDAMED
035.1408S EUDAMED
035.2412S EUDAMED
035.3708S EUDAMED
035.3812S EUDAMED
035.0708S EUDAMED
035.3304S EUDAMED
035.3512S EUDAMED
SLA Roxolid TL FDA UDI
SLActive Roxolid TL FDA UDI
Description
TLX S Implant, Ø 6.5mm WT, SLA® 10mm, Roxolid® FDA UDI
TLX SP Implant, Ø 3.75mm RT, SLActive® 16mm, Roxolid® FDA UDI
TLX S Implant, Ø 4.5mm NT, SLA® 18mm, Roxolid® FDA UDI
TLX S Implant, Ø 3.75mm NT, SLA® 12mm, Roxolid® FDA UDI
TLX S Implant, Ø 3.75mm RT, SLA® 14mm, Roxolid® FDA UDI
TLX SP Implant, Ø 3.75mm RT, SLA® 8mm, Roxolid® FDA UDI
TLX S Implant, Ø 6.5mm WT, SLActive® 6mm, Roxolid® FDA UDI
TLX SP Implant, Ø 6.5mm WT, SLActive® 12mm, Roxolid® FDA UDI
TLX SP Implant, Ø 4.5mm NT, SLA® 12mm, Roxolid® FDA UDI
TLX S Implant, Ø 4.5mm NT, SLActive® 8mm, Roxolid® FDA UDI
TLX SP Implant, Ø 3.75mm NT, SLA® 16mm, Roxolid® FDA UDI
TLX SP Implant, Ø 5.5mm WT, SLActive® 8mm, Roxolid® FDA UDI
TLX SP Implant, Ø 3.75mm NT, SLA® 14mm, Roxolid® FDA UDI
TLX S Implant, Ø 4.5mm RT, SLA® 6mm, Roxolid® FDA UDI
TLX S Implant, Ø 3.75mm RT, SLActive® 6mm, Roxolid® FDA UDI
TLX SP Implant, Ø 6.5mm WT, SLA® 12mm, Roxolid® FDA UDI
TLX S Implant, Ø 5.5mm WT, SLA® 8mm, Roxolid® FDA UDI
TLX S Implant, Ø 3.75mm NT, SLA® 16mm, Roxolid® FDA UDI
TLX SP Implant, Ø 4.5mm RT, SLActive® 12mm, Roxolid® FDA UDI
TLX SP Implant, Ø 6.5mm WT, SLActive® 8mm, Roxolid® FDA UDI
TLX SP Implant, Ø 4.5mm RT, SLActive® 16mm, Roxolid® FDA UDI

Identifiers

Catalog Number
035.0810S FDA UDI
035.3116S FDA UDI
035.0418S FDA UDI
035.0012S FDA UDI
035.0114S FDA UDI
035.2108S FDA UDI
035.1806S FDA UDI
035.3812S FDA UDI
035.2412S FDA UDI
035.1408S FDA UDI
035.2016S FDA UDI
035.3708S FDA UDI
035.2014S FDA UDI
035.0506S FDA UDI
035.1106S FDA UDI
035.2812S FDA UDI
035.0708S FDA UDI
035.0016S FDA UDI
035.3512S FDA UDI
035.3808S FDA UDI
035.3516S FDA UDI
Primary DI / UDI-DI
07630031751850 EUDAMEDFDA UDI
07630031742810 EUDAMEDFDA UDI
07630031751713 EUDAMEDFDA UDI
07630031752123 EUDAMEDFDA UDI
07630031752208 EUDAMEDFDA UDI
07630031742209 EUDAMEDFDA UDI
07630031752055 EUDAMEDFDA UDI
07630031743251 EUDAMEDFDA UDI
07630031742438 EUDAMEDFDA UDI
07630031751249 EUDAMEDFDA UDI
07630031742179 EUDAMEDFDA UDI
07630031743190 EUDAMEDFDA UDI
07630031742162 EUDAMEDFDA UDI
07630031751720 EUDAMEDFDA UDI
07630031751942 EUDAMEDFDA UDI
07630031742681 EUDAMEDFDA UDI
07630031751805 EUDAMEDFDA UDI
07630031752147 EUDAMEDFDA UDI
07630031743077 EUDAMEDFDA UDI
07630031743237 EUDAMEDFDA UDI
07630031743091 EUDAMEDFDA UDI
07630031755575 EUDAMED
Basic UDI-DI
0763003170095R7 EUDAMED
510(k) Number
K200586 FDA 510(k)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 UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 6.5 Millimeter FDA UDI
Length — 10 Millimeter FDA UDI
Outer Diameter — 3.75 Millimeter FDA UDI
Length — 16 Millimeter FDA UDI
Length — 18 Millimeter FDA UDI
Outer Diameter — 4.5 Millimeter FDA UDI
Length — 12 Millimeter FDA UDI
Length — 14 Millimeter FDA UDI
Length — 8 Millimeter FDA UDI
Length — 6 Millimeter FDA UDI
Outer Diameter — 5.5 Millimeter FDA UDI

The Straumann TLX Implant System is a dental implant designed for osseointegration in the jawbone, classified as a Tissue Level Implant. Its fully tapered design enhances primary stability while supporting predictable hard and soft tissue healing, suitable for immediate loading protocols.

The system is supplied as a reusable surgical implant, available in a narrow diameter option of 3.75 mm alongside standard sizes. It is intended for use in dental procedures and has received FDA 510(k) clearance under the Traditional pathway, along with MDR authorization. Sterility and regulatory compliance are ensured through manufacturer-controlled processes.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Straumann TLX™ Implant System, Straumann® TLX, Welcome to Straumann, Straumann® TLX Implant System, TLX Implants Straumann Group

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Institut Straumann AG

Sources (44)

  • FDA 510(k) K200586 24 fields · synced Sep 30, 2026
  • FDA UDI 0488dc5f-f115-406b-9375-62da5273485f 38 fields · synced May 29, 2026
  • FDA UDI ccae0244-eac0-43a2-9421-95453d0bb71c 38 fields · synced May 29, 2026
  • FDA UDI f2b180f8-f5b6-499a-bb38-585e71a9355b 38 fields · synced May 30, 2026
  • FDA UDI f82fb2cb-7010-4e74-8db7-b47101a6fa73 38 fields · synced May 30, 2026
  • FDA UDI 2c4a9ec1-068a-4c38-afe3-d8ef934703d0 38 fields · synced May 30, 2026
  • FDA UDI 10644fb2-89a3-4166-b05c-4f6edb11d2f7 38 fields · synced May 30, 2026
  • FDA UDI b5735888-38cf-4e04-b34c-b461f5c6219b 38 fields · synced May 30, 2026
  • FDA UDI fd847ab4-95b2-4a24-acbc-b53bbc5db898 38 fields · synced May 30, 2026
  • FDA UDI 6d11071a-0d82-446c-8ee7-b2ad52eb0aea 38 fields · synced May 30, 2026
  • FDA UDI 56906e42-d96d-45f4-b12f-cce1cb800ff6 38 fields · synced May 30, 2026
  • FDA UDI a2fc45aa-3d2a-44cd-9825-ef34b83d0179 38 fields · synced May 30, 2026
  • FDA UDI 2a945ebc-60c8-4e45-8cec-2f77feead90f 38 fields · synced May 30, 2026
  • FDA UDI ee5ecc42-4c92-40ee-9ce0-2293c67599a0 38 fields · synced May 30, 2026
  • FDA UDI f2bf94a7-6bc6-45d7-9cc4-5f0328a59fcd 38 fields · synced May 30, 2026
  • FDA UDI 78c98b2b-3de0-47c6-bfdf-b3a9d36cc990 38 fields · synced May 30, 2026
  • FDA UDI 04baace5-abc8-480c-ad76-61c79a3a5a13 38 fields · synced May 30, 2026
  • FDA UDI c4318917-a4a0-44da-9dc1-a5f71da535de 38 fields · synced May 30, 2026
  • FDA UDI 52b08170-fbc5-4f28-8673-ab2e93f5d7e5 38 fields · synced May 30, 2026
  • FDA UDI e51daee6-5048-41c1-9955-3a9abdf37a02 38 fields · synced May 30, 2026
  • FDA UDI ea2efc5a-1bbd-4bfb-b32d-ff4e75136844 38 fields · synced May 30, 2026
  • FDA UDI 71c9a032-a7b8-467b-a074-2ec4805879f6 38 fields · synced May 30, 2026
  • EUDAMED b86a07ee-2904-46d9-be06-06643ab3f914 61 fields · synced Jul 8, 2026
  • EUDAMED 2b3814c5-aa43-407e-898b-c256a019db56 61 fields · synced Jul 9, 2026
  • EUDAMED 1af296f2-9e96-4337-97cc-28c72cf568fb 61 fields · synced Jul 11, 2026
  • EUDAMED b6f986c2-1e4e-4927-be08-12a23103e7a6 61 fields · synced Jul 13, 2026
  • EUDAMED 834bcdcd-486a-4e72-8d5a-b5f990410f0b 61 fields · synced Jul 14, 2026
  • EUDAMED c9dfc7f9-a832-4e27-ac38-cbe821165895 61 fields · synced Jul 15, 2026
  • EUDAMED 527c23c2-813c-4eef-a76c-95e7e7d2f229 61 fields · synced Jul 15, 2026
  • EUDAMED 091ff199-a58a-44a8-9d50-6ccb6776b849 61 fields · synced Jul 15, 2026
  • EUDAMED 1ba0a06d-f902-40dd-b1da-f2b5348ea50e 61 fields · synced Jul 16, 2026
  • EUDAMED 21dc8ddc-03be-4afb-bfaf-7e28e95f7f28 61 fields · synced Jul 16, 2026
  • EUDAMED 89b97ffe-e6bf-4905-9f9e-f2efb346c12d 61 fields · synced Jul 17, 2026
  • EUDAMED fae2a75f-480b-4f8c-824d-62fe03174e36 61 fields · synced Jul 21, 2026
  • EUDAMED a0d1c16f-0abb-40e8-93ff-f0f5dc39dd72 61 fields · synced Jul 21, 2026
  • EUDAMED 0de6eecd-e1cf-450c-b17b-0a362102870f 61 fields · synced Jul 21, 2026
  • EUDAMED 7d562a3f-9e8f-4128-8e8f-0e9512981d31 61 fields · synced Jul 22, 2026
  • EUDAMED 2526bec8-45a9-4358-a398-2be08640120e 61 fields · synced Jul 25, 2026
  • EUDAMED 2cc4ddc1-027b-48c0-b4fa-715296ca937e 61 fields · synced Jul 25, 2026
  • EUDAMED a89208b8-7d5b-4de1-890e-05fb23c1b4b5 61 fields · synced Jul 28, 2026
  • EUDAMED b5d2f305-bbb1-41be-93f9-978924cc7822 61 fields · synced Aug 2, 2026
  • EUDAMED 1cb1cf65-4f27-456b-a4b3-e30fcf8f78fd 61 fields · synced Aug 2, 2026
  • EUDAMED c804f247-96b5-47e3-b9ea-8332a986c010 61 fields · synced Aug 2, 2026
  • EUDAMED b94da654-bca8-4b8f-adae-d813453e15dc 61 fields · synced Sep 17, 2026