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TLC Implant

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref 035.4816SRef 035.4716SRef 035.4810SRef 035.6814SRef 035.6716SRef 035.5716SRef 035.7108SRef 035.4714SRef 035.6310SRef 035.7212SRef 035.4014SRef 035.5706SRef 035.5816SRef 035.7810SRef 035.6516SRef 035.5608SRef 035.7312SRef 035.6608SRef 035.6806S

by Institut Straumann AG

Identity

Trade Name
Straumann® BLC and TLC Implants FDA UDI
Straumann® BLC and TLC Implants - Line extension FDA UDI
Generic Name
Screw endosteal dental implant, two-piece FDA UDI
Device Name
TLC Implant EUDAMED
TLC S Implant, Ø 3.3mm NT, SLA® 14mm, Roxolid® FDA UDI
TLC SP Implant, Ø 3.75mm RT, SLA® 10mm, Roxolid® FDA UDI
TLC S Implant, Ø 5.5mm WT, SLActive 16mm, Roxolid FDA UDI
TLC SP Implant, Ø 4.5mm RT, SLA® 16mm, Roxolid® FDA UDI
TLC SP Implant, Ø 3.75mm NT, SLActive® 12mm, Roxolid® FDA UDI
TLC SP Implant, Ø 3.3mm RT, SLActive® 8mm, Roxolid® FDA UDI
TLC SP Implant, Ø 4.5mm WT, SLA® 8mm, Roxolid® FDA UDI
TLC SP Implant, Ø 6.5mm WT, SLActive® 10mm, Roxolid® FDA UDI
TLC S Implant, Ø 6.5mm WT, SLActive 16mm, Roxolid FDA UDI
TLC S Implant, Ø 5.5mm WT, SLActive® 6mm, Roxolid® FDA UDI
TLC SP Implant, Ø 3.75mm RT, SLActive® 12mm, Roxolid® FDA UDI
TLC SP Implant, Ø 6.5mm WT, SLA® 6mm, Roxolid® FDA UDI
TLC S Implant, Ø 4.5mm WT, SLActive® 8mm, Roxolid® FDA UDI
Model / Reference
035.4816S EUDAMED
035.4716S EUDAMED
035.4810S EUDAMED
035.6814S EUDAMED
035.6716S EUDAMED
035.5716S EUDAMED
035.7108S EUDAMED
035.4714S EUDAMED
035.6310S EUDAMED
035.7212S EUDAMED
035.4014S EUDAMED
035.5706S EUDAMED
035.5816S EUDAMED
035.7810S EUDAMED
035.6516S EUDAMED
035.5608S EUDAMED
035.7312S EUDAMED
035.6608S EUDAMED
035.6806S EUDAMED
SLA Roxolid TL FDA UDI
SLActive Roxolid TL FDA UDI
Description
TLC S Implant, Ø 3.3mm NT, SLA® 14mm, Roxolid® FDA UDI
TLC SP Implant, Ø 3.75mm RT, SLA® 10mm, Roxolid® FDA UDI
TLC S Implant, Ø 5.5mm WT, SLActive 16mm, Roxolid FDA UDI
TLC SP Implant, Ø 4.5mm RT, SLA® 16mm, Roxolid® FDA UDI
TLC SP Implant, Ø 3.75mm NT, SLActive® 12mm, Roxolid® FDA UDI
TLC SP Implant, Ø 3.3mm RT, SLActive® 8mm, Roxolid® FDA UDI
TLC SP Implant, Ø 4.5mm WT, SLA® 8mm, Roxolid® FDA UDI
TLC SP Implant, Ø 6.5mm WT, SLActive® 10mm, Roxolid® FDA UDI
TLC S Implant, Ø 6.5mm WT, SLActive 16mm, Roxolid FDA UDI
TLC S Implant, Ø 5.5mm WT, SLActive® 6mm, Roxolid® FDA UDI
TLC SP Implant, Ø 3.75mm RT, SLActive® 12mm, Roxolid® FDA UDI
TLC SP Implant, Ø 6.5mm WT, SLA® 6mm, Roxolid® FDA UDI
TLC S Implant, Ø 4.5mm WT, SLActive® 8mm, Roxolid® FDA UDI

Identifiers

Catalog Number
035.4014S FDA UDI
035.6310S FDA UDI
035.5716S FDA UDI
035.6516S FDA UDI
035.7212S FDA UDI
035.7108S FDA UDI
035.6608S FDA UDI
035.7810S FDA UDI
035.5816S FDA UDI
035.5706S FDA UDI
035.7312S FDA UDI
035.6806S FDA UDI
035.5608S FDA UDI
Primary DI / UDI-DI
07630031765543 EUDAMED
07630031765482 EUDAMED
07630031765512 EUDAMED
07630031766021 EUDAMED
07630031765970 EUDAMED
07630031765727 EUDAMEDFDA UDI
07630031765338 EUDAMEDFDA UDI
07630031765178 EUDAMEDFDA UDI
07630031765901 EUDAMEDFDA UDI
07630031765116 EUDAMEDFDA UDI
07630031766694 EUDAMEDFDA UDI
07630031766625 EUDAMEDFDA UDI
07630031766243 EUDAMEDFDA UDI
07630031765789 EUDAMEDFDA UDI
07630031765673 EUDAMEDFDA UDI
07630031765253 EUDAMEDFDA UDI
07630031765987 EUDAMEDFDA UDI
07630031766489 EUDAMEDFDA UDI
07630031765475 EUDAMED
Basic UDI-DI
0763003170108QP EUDAMED
510(k) Number
K230108 FDA UDI
K234049 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

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Length — 14 Millimeter FDA UDI
Outer Diameter — 3.3 Millimeter FDA UDI
Outer Diameter — 3.75 Millimeter FDA UDI
Length — 10 Millimeter FDA UDI
Outer Diameter — 5.5 Millimeter FDA UDI
Length — 16 Millimeter FDA UDI
Outer Diameter — 4.5 Millimeter FDA UDI
Length — 12 Millimeter FDA UDI
Length — 8 Millimeter FDA UDI
Outer Diameter — 6.5 Millimeter FDA UDI
Length — 6 Millimeter FDA UDI

TLC 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 (32)

  • EUDAMED 7968c172-d514-4858-91a4-c5bba96d96c8 61 fields · synced Sep 18, 2026
  • EUDAMED e934c473-cd09-4543-85e0-0a420a1a00bb 61 fields · synced May 16, 2026
  • EUDAMED beb5eba5-ab31-40cc-bfdf-8f7dd9436f1e 61 fields · synced May 17, 2026
  • EUDAMED e320a00a-d410-4a2c-87e3-6555841cd998 61 fields · synced May 17, 2026
  • EUDAMED b5b32508-caa1-4b1d-ae95-7b8b26b653f9 61 fields · synced May 18, 2026
  • EUDAMED 72a57626-347a-4552-839c-cd4b6fcf3412 61 fields · synced May 18, 2026
  • FDA UDI 859f6c91-b1b0-497f-b7e9-35ff51214070 38 fields · synced May 26, 2026
  • FDA UDI a3d5c638-d096-4b77-8c61-4dfc47fff347 38 fields · synced May 29, 2026
  • FDA UDI c2f036c1-ef79-4233-8a5b-5a47a34f0523 38 fields · synced May 29, 2026
  • FDA UDI e807be58-7f1e-48c2-8240-5f2f179faec6 38 fields · synced May 29, 2026
  • FDA UDI 01cb8547-f03c-444e-b3b8-8df080fa3e79 38 fields · synced May 29, 2026
  • FDA UDI 98ffdc12-e0b5-4c39-9cb7-28b697e19359 38 fields · synced May 29, 2026
  • FDA UDI a338bdff-80ac-4f30-8699-e2d823bd0909 38 fields · synced May 30, 2026
  • FDA UDI 08a00901-2d87-416b-afbe-041292fff7c2 38 fields · synced May 30, 2026
  • FDA UDI 8a973aa7-f739-4607-9a94-8f8d7dcdd176 38 fields · synced May 30, 2026
  • FDA UDI ac9f7021-956a-41ae-be53-1d2584801cfc 38 fields · synced May 30, 2026
  • FDA UDI 50427b52-94c3-48b8-b139-3257dc4975e9 38 fields · synced May 30, 2026
  • FDA UDI 3f61969a-c016-4438-9b37-99be11bbbbfa 38 fields · synced May 30, 2026
  • FDA UDI 3d0e5ae3-5c81-4178-b571-62909bbe2d9c 38 fields · synced May 30, 2026
  • EUDAMED db2963a8-d8ef-4c2c-889c-5da40bd8b968 61 fields · synced Jul 9, 2026
  • EUDAMED 0dab5eea-e963-4236-b2d8-a5c14a74d928 61 fields · synced Jul 10, 2026
  • EUDAMED a2f99ac3-8df4-46e7-904f-a51969519094 61 fields · synced Jul 11, 2026
  • EUDAMED 0ab2e179-6f21-4ed5-81c9-074e87ebe1e1 61 fields · synced Jul 13, 2026
  • EUDAMED 7b0a1e98-cb89-43b5-8d3a-7c4101947725 61 fields · synced Jul 16, 2026
  • EUDAMED 476822f8-8e52-45d0-aadc-1877492f3e38 61 fields · synced Jul 18, 2026
  • EUDAMED 28129649-e7a0-46a3-a689-c62587668e25 61 fields · synced Jul 19, 2026
  • EUDAMED 8b028310-410c-4464-8c02-2ca82890b4f5 61 fields · synced Jul 20, 2026
  • EUDAMED 1dace59f-2738-48bd-94b7-3f4facac07eb 61 fields · synced Jul 21, 2026
  • EUDAMED 0c73b284-fd3a-4980-8733-7f7c0440322a 61 fields · synced Jul 26, 2026
  • EUDAMED 389c4aaf-2135-4709-ae55-143d3aa0c970 61 fields · synced Jul 27, 2026
  • EUDAMED dd5efc4f-7482-41c7-9fb0-07405cd85e26 61 fields · synced Jul 30, 2026
  • EUDAMED 55ced256-7ac9-4fc7-85b6-fb410364c8aa 61 fields · synced Sep 18, 2026