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Final Abutment: Variobase
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 010.5431Ref 010.5369Ref 010.5376Ref 062.5003Ref 062.5019Ref 010.5432Ref 010.5359Ref 062.5023Ref 010.5358Ref 010.5361Ref 037.1201Ref 062.5059Ref 010.5433Ref 062.5014Ref 010.5417Ref 010.5375Ref 062.5071Ref 062.5025Ref 010.5418Ref 062.5075Ref 062.5010Ref 062.5009Ref 062.5022Ref 062.5073Ref 010.5373Ref 062.5005Ref 010.5372Ref 010.5362Ref 062.5066Ref 062.5077Ref 062.5026Ref 062.5063Ref 010.5426Ref 062.4994Ref 010.5435Ref 010.5355Ref 010.5411Ref 062.5027Ref 062.5076Ref 010.5357Ref 010.5430Ref 010.5363Ref 010.5345Ref 010.5356Ref 010.5367Ref 062.5012
Identity
- Trade Name
- Straumann TLX Implant System FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Final Abutment: Variobase EUDAMEDRT Variobase® for Crown incl. screw, Ø 5mm, AH 6mm, TAN FDA UDI
- Model / Reference
- 010.5431 EUDAMED010.5369 EUDAMED010.5376 EUDAMED062.5003 EUDAMED062.5019 EUDAMED010.5432 EUDAMED010.5359 EUDAMED062.5023 EUDAMED010.5358 EUDAMED010.5361 EUDAMED037.1201 EUDAMED062.5059 EUDAMED010.5433 EUDAMED062.5014 EUDAMED010.5417 EUDAMED010.5375 EUDAMED062.5071 EUDAMED062.5025 EUDAMED010.5418 EUDAMED062.5075 EUDAMED062.5010 EUDAMED062.5009 EUDAMED062.5022 EUDAMED062.5073 EUDAMED010.5373 EUDAMED062.5005 EUDAMED010.5372 EUDAMED010.5362 EUDAMED062.5066 EUDAMED062.5077 EUDAMED062.5026 EUDAMED062.5063 EUDAMED010.5426 EUDAMED062.4994 EUDAMED010.5435 EUDAMED010.5355 EUDAMED010.5411 EUDAMED062.5027 EUDAMED062.5076 EUDAMED010.5357 EUDAMED010.5430 EUDAMED010.5363 EUDAMED010.5345 EUDAMED010.5356 EUDAMED010.5367 EUDAMED062.5012 EUDAMEDFinal Abutments FDA UDI
- Description
- RT Variobase® for Crown incl. screw, Ø 5mm, AH 6mm, TAN FDA UDI
Identifiers
- Catalog Number
- 037.1201 FDA UDI
- Primary DI / UDI-DI
- 07630031773838 EUDAMED07630031771100 EUDAMED07630031771179 EUDAMED07630031771216 EUDAMED07630031771346 EUDAMED07630031773845 EUDAMED07630031771001 EUDAMED07630031771384 EUDAMED07630031770998 EUDAMED07630031771025 EUDAMED07630031746535 EUDAMEDFDA UDI07630031775177 EUDAMED07630031773852 EUDAMED07630031771292 EUDAMED07630031773692 EUDAMED07630031771162 EUDAMED07630031773555 EUDAMED07630031771407 EUDAMED07630031773708 EUDAMED07630031773593 EUDAMED07630031771254 EUDAMED07630031771247 EUDAMED07630031771377 EUDAMED07630031773579 EUDAMED07630031771148 EUDAMED07630031771230 EUDAMED07630031771131 EUDAMED07630031771032 EUDAMED07630031773500 EUDAMED07630031773616 EUDAMED07630031771414 EUDAMED07630031773371 EUDAMED07630031773784 EUDAMED07630031771209 EUDAMED07630031773876 EUDAMED07630031770967 EUDAMED07630031775207 EUDAMED07630031771421 EUDAMED07630031773609 EUDAMED07630031770981 EUDAMED07630031773821 EUDAMED07630031771049 EUDAMED07630031770943 EUDAMED07630031770974 EUDAMED07630031771087 EUDAMED07630031771278 EUDAMED
- Basic UDI-DI
- 0763003170097RB EUDAMED
- 510(k) Number
- K200586 FDA UDI
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 5 Millimeter FDA UDIHeight — 6 Millimeter FDA UDI
Final Abutment: Variobase 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0763003170097RB | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Institut Straumann AG
- EUDAMED SRN
- CH-MF-000009933
- Authorised Representative
- Etkon GmbH DE-AR-000009335
Sources (47)
- EUDAMED cbcc7f86-54b5-48d9-b572-ef23e3b02a75 61 fields · synced Sep 18, 2026
- EUDAMED 93380df0-c1fd-4c91-81fb-5807188e9e57 61 fields · synced May 16, 2026
- EUDAMED d61565d9-2ac6-44be-a283-3cdcc2bcb99a 61 fields · synced May 16, 2026
- EUDAMED 5882291b-42cd-40c8-8667-d00457ddb7b2 61 fields · synced May 16, 2026
- EUDAMED 05e96c74-c12a-4ee2-8fa6-417d350a45a8 61 fields · synced May 16, 2026
- EUDAMED c53a01a8-5efe-4c46-884a-3bb0c84e4c9d 61 fields · synced May 16, 2026
- EUDAMED fde0151d-b02e-4500-981e-c85ff9357f41 61 fields · synced May 16, 2026
- EUDAMED f644dee4-795f-4416-ba0d-dd5d73ceb03a 61 fields · synced May 16, 2026
- EUDAMED 91d318a4-5a09-486f-b241-72c9514eefe7 61 fields · synced May 16, 2026
- EUDAMED bc4ed4ac-75e8-43ab-8999-baa291e81347 61 fields · synced May 16, 2026
- EUDAMED e2c139ee-b80e-4252-85ac-bc6a26beab26 61 fields · synced May 17, 2026
- EUDAMED 1cb6a90b-d750-4350-a953-0c690b9dfec1 61 fields · synced May 17, 2026
- EUDAMED 9b1c6275-87f7-48e9-8247-3a6ac543e8f0 61 fields · synced May 17, 2026
- EUDAMED 475096c1-daf0-485b-a9ee-b638171335b4 61 fields · synced May 17, 2026
- EUDAMED 5c39f290-66a2-480a-bc7e-a9500ac752d3 61 fields · synced May 17, 2026
- EUDAMED b311f126-a06d-4b61-a4f2-b1273cbce763 61 fields · synced May 17, 2026
- EUDAMED 520f012e-455b-4c18-ab5b-18bda268a2da 61 fields · synced May 17, 2026
- EUDAMED 91fe8252-00c6-429e-a541-cbb7ffe72fbf 61 fields · synced May 17, 2026
- EUDAMED a72ab30c-3de2-47a0-b53b-d110fa038c2e 61 fields · synced May 17, 2026
- EUDAMED 382d4e9e-65ff-41d5-825a-10560e26b05c 61 fields · synced May 17, 2026
- EUDAMED a600bfa3-0f4e-4a43-b6e5-81440066710b 61 fields · synced May 18, 2026
- EUDAMED 7ccd059f-35f2-4332-a318-f84ab4df75f6 61 fields · synced May 18, 2026
- EUDAMED d0f48881-7a2a-45b7-9f44-f7a4bc9c0261 61 fields · synced May 18, 2026
- EUDAMED a8421d84-5883-468d-bf9b-f0028eccb631 61 fields · synced May 18, 2026
- EUDAMED 93d34cb3-bd59-49ce-bc54-27cced6ff670 61 fields · synced May 18, 2026
- EUDAMED d5121057-5a01-4e18-b50b-a8018db97b9f 61 fields · synced May 18, 2026
- EUDAMED bf29cbc5-5fe4-48f7-860e-5b2b6f1ded5d 61 fields · synced May 18, 2026
- EUDAMED 66aeeffe-2613-44f9-b83d-3a7034bf525e 61 fields · synced May 18, 2026
- EUDAMED c46f1067-0abc-460c-8917-359acddae547 61 fields · synced May 18, 2026
- EUDAMED 62e4a2a7-871d-481a-9d36-5562229f4874 61 fields · synced May 18, 2026
- EUDAMED 9fcfcc95-1d21-4d3e-bc96-152b98d568fe 61 fields · synced May 18, 2026
- EUDAMED b93e7b8c-23fe-4009-8316-05aedf248049 61 fields · synced May 18, 2026
- EUDAMED 43f6c1b8-fffa-49e0-a156-a2785ff4de79 61 fields · synced May 18, 2026
- EUDAMED 713aca98-7d77-49a3-9ebf-1fec108ca428 61 fields · synced May 18, 2026
- EUDAMED 897b63ef-f923-4c69-b3c5-6fdf2687a995 61 fields · synced May 18, 2026
- EUDAMED d49ec9b8-d66a-4c62-9a3b-4123c44a6e72 61 fields · synced May 18, 2026
- EUDAMED 10e5295b-a750-4a84-ade8-f28ac5e13789 61 fields · synced May 18, 2026
- EUDAMED 9619c14d-b7bd-41d5-a5fb-4f0028ec45aa 61 fields · synced May 18, 2026
- EUDAMED 00c1112f-6669-477d-bc22-7fc131c02624 61 fields · synced May 18, 2026
- EUDAMED 4599f63b-28b0-4ee9-8f10-8d9ed4712e72 61 fields · synced May 18, 2026
- EUDAMED e95c535f-13c7-4b01-8177-fbb28ceab146 61 fields · synced May 18, 2026
- EUDAMED 17c83678-41fa-4847-b66c-91d1148c650d 61 fields · synced May 19, 2026
- EUDAMED bf9b6531-b3ce-41d4-80e3-8a496eab6a0e 61 fields · synced May 19, 2026
- EUDAMED 1f2b192c-f222-4895-998d-bd60906e5fcb 61 fields · synced May 19, 2026
- EUDAMED 889c068f-27be-43ef-9457-5564614d29be 61 fields · synced May 19, 2026
- EUDAMED f0500e01-edce-49ca-98a3-6bfe83d47d42 61 fields · synced May 19, 2026
- FDA UDI 088e4380-52ba-459e-a5d4-bcf6b720c2fd 37 fields · synced May 30, 2026