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Cemented Abutment
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref CARRN50505Ref CARRH70207SRef CARRN50505SRef CARRN70407SRef CARRH40505Ref CARRN70305Ref CARRN40505SRef CARRN40407SRef CARRN60207Ref CARRH50207SRef CARRN70207SRef CARRN50407Ref CARRH70207Ref CARRN40205Ref CARRH70405SRef CARRH70407Ref CARRH70307Ref CARRN60407Ref CARRH40505SRef CARRN40307SRef CARRN40507Ref CARRH40407SRef CARRH60407Ref CARRH70405Ref CARRN40505Ref CARRH60305Ref CARRN60507Ref CARRN60305SRef CARRN60405SRef CARRN70305SRef CARRH70205Ref CARRN70505SRef CARRN40507SRef AARRA40152Ref CARRH60505Ref CARRH50507Ref CARRH40507SRef CARRN50207SRef CARRH50407Ref CARRH60405Ref CARRH60507Ref CARRN60205Ref CARRN50405Ref CARRH60205SRef CARRN60305Ref CARRN50205Ref CARRH50205Ref CARRN50405SRef CARRH70305Ref CARRN40305SRef CARRN40205SRef CARRH70305SRef CASRH52104SRef CARRN50407SRef CARRH40405SRef CARRH40407Ref CARRH60407SRef CARRH40307SRef CARRH50507SRef CARRN70505Ref CARRH40207Ref CARRH60207SRef CARRH40305Ref CARRH50307Ref CASRN52305Ref CARRH60307Ref CARRN40405Ref CARRN50507SRef CARRH50305Ref CARRN70507SRef CARRN40207Ref CARRH70505SRef CASRH45107SRef CARRN70405Ref CARRH50207Ref CARRN60307Ref CARRH50205SRef CARRH40305SRef CARRN70207Ref CARRH60305SRef CARRN50507Ref CARRN60205S
Identity
- Trade Name
- Cemented Abutment EUDAMEDFDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Cemented Abutment EUDAMED2195-MED-2113901 EUDAMED
- Model / Reference
- CARRN50505 EUDAMEDCARRH70207S EUDAMEDCARRN50505S EUDAMEDCARRN70407S EUDAMEDCARRH40505 EUDAMEDCARRN70305 EUDAMEDCARRN40505S EUDAMEDCARRN40407S EUDAMEDCARRN60207 EUDAMEDCARRH50207S EUDAMEDCARRN70207S EUDAMEDCARRN50407 EUDAMEDCARRH70207 EUDAMEDCARRN40205 EUDAMEDCARRH70405S EUDAMEDCARRH70407 EUDAMEDCARRH70307 EUDAMEDCARRN60407 EUDAMEDCARRH40505S EUDAMEDCARRN40307S EUDAMEDCARRN40507 EUDAMEDCARRH40407S EUDAMEDCARRH60407 EUDAMEDCARRH70405 EUDAMEDCARRN40505 EUDAMEDCARRH60305 EUDAMEDCARRN60507 EUDAMEDCARRN60305S EUDAMEDCARRN60405S EUDAMEDCARRN70305S EUDAMEDCARRH70205 EUDAMEDCARRN70505S EUDAMEDCARRN40507S EUDAMEDAARRA40152 EUDAMEDCARRH60505 EUDAMEDCARRH50507 EUDAMEDCARRH40507S EUDAMEDCARRN50207S EUDAMEDCARRH50407 EUDAMEDCARRH60405 EUDAMEDCARRH60507 EUDAMEDCARRN60205 EUDAMEDCARRN50405 EUDAMEDCARRH60205S EUDAMEDCARRN60305 EUDAMEDCARRN50205 EUDAMEDCARRH50205 EUDAMEDCARRN50405S EUDAMEDCARRH70305 EUDAMEDCARRN40305S EUDAMEDCARRN40205S EUDAMEDCARRH70305S EUDAMEDCASRH52104S EUDAMEDFDA UDICARRN50407S EUDAMEDCARRH40405S EUDAMEDCARRH40407 EUDAMEDCARRH60407S EUDAMEDCARRH40307S EUDAMEDCARRH50507S EUDAMEDCARRN70505 EUDAMEDCARRH40207 EUDAMEDCARRH60207S EUDAMEDCARRH40305 EUDAMEDCARRH50307 EUDAMEDCASRN52305 EUDAMEDFDA UDICARRH60307 EUDAMEDCARRN40405 EUDAMEDCARRN50507S EUDAMEDCARRH50305 EUDAMEDCARRN70507S EUDAMEDCARRN40207 EUDAMEDCARRH70505S EUDAMEDCASRH45107S EUDAMEDFDA UDICARRN70405 EUDAMEDCARRH50207 EUDAMEDCARRN60307 EUDAMEDCARRH50205S EUDAMEDCARRH40305S EUDAMEDCARRN70207 EUDAMEDCARRH60305S EUDAMEDCARRN50507 EUDAMEDCARRN60205S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800070212868 EUDAMED08800070213360 EUDAMED08800070213513 EUDAMED08800070213704 EUDAMED08800070212462 EUDAMED08800070213001 EUDAMED08800070213438 EUDAMED08800070213469 EUDAMED08800070212950 EUDAMED08800070213209 EUDAMED08800070213681 EUDAMED08800070212899 EUDAMED08800070212714 EUDAMED08800070212752 EUDAMED08800070213346 EUDAMED08800070212738 EUDAMED08800070212721 EUDAMED08800070212974 EUDAMED08800070213117 EUDAMED08800070213452 EUDAMED08800070212820 EUDAMED08800070213148 EUDAMED08800070212653 EUDAMED08800070212691 EUDAMED08800070212783 EUDAMED08800070212608 EUDAMED08800070212981 EUDAMED08800070213575 EUDAMED08800070213582 EUDAMED08800070213650 EUDAMED08800070212677 EUDAMED08800070213674 EUDAMED08800070213476 EUDAMED08800070226971 EUDAMED08800070212622 EUDAMED08800070212585 EUDAMED08800070213155 EUDAMED08800070213520 EUDAMED08800070212578 EUDAMED08800070212615 EUDAMED08800070212660 EUDAMED08800070212912 EUDAMED08800070212851 EUDAMED08800070213247 EUDAMED08800070212929 EUDAMED08800070212837 EUDAMED08800070212516 EUDAMED08800070213506 EUDAMED08800070212684 EUDAMED08800070213414 EUDAMED08800070213407 EUDAMED08800070213339 EUDAMED08800070207161 EUDAMEDFDA UDI08800070213544 EUDAMED08800070213100 EUDAMED08800070212493 EUDAMED08800070213308 EUDAMED08800070213131 EUDAMED08800070213230 EUDAMED08800070213025 EUDAMED08800070212479 EUDAMED08800070213285 EUDAMED08800070212448 EUDAMED08800070212561 EUDAMED08800070206300 EUDAMEDFDA UDI08800070212646 EUDAMED08800070212776 EUDAMED08800070213551 EUDAMED08800070212523 EUDAMED08800070213711 EUDAMED08800070212790 EUDAMED08800070213353 EUDAMED08800070207093 EUDAMEDFDA UDI08800070213018 EUDAMED08800070212554 EUDAMED08800070212967 EUDAMED08800070213162 EUDAMED08800070213094 EUDAMED08800070213032 EUDAMED08800070213254 EUDAMED08800070212905 EUDAMED08800070213568 EUDAMED
- Basic UDI-DI
- B-08800070212868 EUDAMEDB-08800070213360 EUDAMEDB-08800070213513 EUDAMEDB-08800070213704 EUDAMEDB-08800070212462 EUDAMEDB-08800070213001 EUDAMEDB-08800070213438 EUDAMEDB-08800070213469 EUDAMEDB-08800070212950 EUDAMEDB-08800070213209 EUDAMEDB-08800070213681 EUDAMEDB-08800070212899 EUDAMEDB-08800070212714 EUDAMEDB-08800070212752 EUDAMEDB-08800070213346 EUDAMEDB-08800070212738 EUDAMEDB-08800070212721 EUDAMEDB-08800070212974 EUDAMEDB-08800070213117 EUDAMEDB-08800070213452 EUDAMEDB-08800070212820 EUDAMEDB-08800070213148 EUDAMEDB-08800070212653 EUDAMEDB-08800070212691 EUDAMEDB-08800070212783 EUDAMEDB-08800070212608 EUDAMEDB-08800070212981 EUDAMEDB-08800070213575 EUDAMEDB-08800070213582 EUDAMEDB-08800070213650 EUDAMEDB-08800070212677 EUDAMEDB-08800070213674 EUDAMEDB-08800070213476 EUDAMEDB-08800070226971 EUDAMEDB-08800070212622 EUDAMEDB-08800070212585 EUDAMEDB-08800070213155 EUDAMEDB-08800070213520 EUDAMEDB-08800070212578 EUDAMEDB-08800070212615 EUDAMEDB-08800070212660 EUDAMEDB-08800070212912 EUDAMEDB-08800070212851 EUDAMEDB-08800070213247 EUDAMEDB-08800070212929 EUDAMEDB-08800070212837 EUDAMEDB-08800070212516 EUDAMEDB-08800070213506 EUDAMEDB-08800070212684 EUDAMEDB-08800070213414 EUDAMEDB-08800070213407 EUDAMEDB-08800070213339 EUDAMEDB-08800070207161 EUDAMEDB-08800070213544 EUDAMEDB-08800070213100 EUDAMEDB-08800070212493 EUDAMEDB-08800070213308 EUDAMEDB-08800070213131 EUDAMEDB-08800070213230 EUDAMEDB-08800070213025 EUDAMEDB-08800070212479 EUDAMEDB-08800070213285 EUDAMEDB-08800070212448 EUDAMEDB-08800070212561 EUDAMEDB-08800070206300 EUDAMEDB-08800070212646 EUDAMEDB-08800070212776 EUDAMEDB-08800070213551 EUDAMEDB-08800070212523 EUDAMEDB-08800070213711 EUDAMEDB-08800070212790 EUDAMEDB-08800070213353 EUDAMEDB-08800070207093 EUDAMEDB-08800070213018 EUDAMEDB-08800070212554 EUDAMEDB-08800070212967 EUDAMEDB-08800070213162 EUDAMEDB-08800070213094 EUDAMEDB-08800070213032 EUDAMEDB-08800070213254 EUDAMEDB-08800070212905 EUDAMEDB-08800070213568 EUDAMED
- 510(k) Number
- K211090 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 EUDAMEDGreece EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDEUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Cemented Abutment by Izenimplant Co., Ltd — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800070212868 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Izenimplant Co., Ltd
- EUDAMED SRN
- KR-MF-000026205
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (87)
- EUDAMED 4e384bd0-a68c-491f-951d-cec9ab4dfae6 61 fields · synced Sep 30, 2026
- EUDAMED d6007dd1-ddcb-4098-a16f-0e51670fffe3 61 fields · synced May 11, 2026
- EUDAMED 0d795910-fd5b-4a57-be67-b25ac4c87108 61 fields · synced May 11, 2026
- EUDAMED 149772b7-d2cd-4105-84f5-f812d4edb0b2 61 fields · synced May 11, 2026
- EUDAMED 1581576b-6382-4a2e-9492-2eb2991041b4 61 fields · synced May 11, 2026
- EUDAMED 66d7d3d1-b993-4239-a80b-086f2925da60 61 fields · synced May 16, 2026
- EUDAMED 5c805793-1e77-4089-8aa8-b76922bb525a 61 fields · synced May 16, 2026
- EUDAMED d51c80f4-9c46-4a27-b9dd-28c99c3592bf 61 fields · synced May 16, 2026
- EUDAMED aeb873be-c1fb-4566-a9f6-decc18011aaa 61 fields · synced May 16, 2026
- EUDAMED d7e49ffe-d009-4e02-a04e-ed5382d54966 61 fields · synced May 16, 2026
- EUDAMED a7229b83-7c82-4627-9686-d88061419372 61 fields · synced May 16, 2026
- EUDAMED c3722bd9-0503-43bc-b14a-6ec3e3276010 61 fields · synced May 16, 2026
- EUDAMED 270adc39-f360-424c-81e9-fe2c759af984 61 fields · synced May 16, 2026
- EUDAMED f94b3514-db1c-441a-b42f-5f669fe1bb4d 61 fields · synced May 16, 2026
- EUDAMED f3a51eb7-04fa-4359-8471-47ca3c1b14b2 61 fields · synced May 16, 2026
- EUDAMED bb06c784-ae2e-4213-b4ea-36447ec80e59 61 fields · synced May 16, 2026
- EUDAMED 3751450b-4eb4-4ab4-a19a-a1c917e09336 61 fields · synced May 17, 2026
- EUDAMED 7c19e33b-4659-4b41-b53d-244dd04f1b78 61 fields · synced May 17, 2026
- EUDAMED f360c4e7-9eba-4bf6-afae-f38493207f3a 61 fields · synced May 17, 2026
- EUDAMED dbd6178c-3e2e-49cc-b1df-ec8f31179bfa 61 fields · synced May 17, 2026
- EUDAMED b0addf6c-7f57-4fab-8ade-05e26f50bd82 61 fields · synced May 17, 2026
- EUDAMED 6450750d-7915-4552-8825-c49ce3b54feb 61 fields · synced May 17, 2026
- EUDAMED 61cb163c-f8c2-4c46-bbd1-ae684209074a 61 fields · synced May 17, 2026
- EUDAMED 76bb8e6c-019d-42eb-9529-c5be8fc76ab5 61 fields · synced May 17, 2026
- EUDAMED ce3c20e3-b6b4-4c08-b6ac-c3c9cf84eed3 61 fields · synced May 17, 2026
- EUDAMED 21949aee-60c4-49f4-9716-ff0b32ed9f73 61 fields · synced May 17, 2026
- EUDAMED 6ae4c4c2-20d8-4f23-91a2-b71a27fdd4ec 61 fields · synced May 17, 2026
- EUDAMED 41485c38-3af7-4fc4-bf25-e60a3bb2a29b 61 fields · synced May 17, 2026
- EUDAMED 75a65bdf-53c2-4f39-a935-a199870e51f6 61 fields · synced May 17, 2026
- EUDAMED cf820df2-a48e-4067-be61-4e1e483eec79 61 fields · synced May 17, 2026
- EUDAMED a282a656-9432-4c7a-98a2-eb0ceaaea038 61 fields · synced May 17, 2026
- EUDAMED 613a2d99-da33-422e-94c3-c310255475b9 61 fields · synced May 17, 2026
- EUDAMED 6c2ee3d7-247a-4d83-9875-2187b906a59b 61 fields · synced May 17, 2026
- EUDAMED 189daf7f-e26c-41e4-89e5-a9a9cd734dc7 61 fields · synced May 17, 2026
- EUDAMED bd4808cd-95fb-4e78-a26d-0fafd9657304 61 fields · synced May 17, 2026
- EUDAMED be9a03f9-77ea-47c5-bdd8-32fc5c97ca0c 61 fields · synced May 17, 2026
- EUDAMED d7e1769c-5e1d-4a20-8d72-f50f29aeda04 61 fields · synced May 17, 2026
- EUDAMED a2fbc8e2-f3d7-4f8c-83b1-76761b7634c7 61 fields · synced May 17, 2026
- EUDAMED 4e125371-6ef1-4a23-9f05-464e073d8573 61 fields · synced May 17, 2026
- EUDAMED e3831982-d17a-440a-9371-2aaff3d238cc 61 fields · synced May 18, 2026
- EUDAMED 38fbedc1-190f-4c77-8066-494f7c69cfd6 61 fields · synced May 18, 2026
- EUDAMED cfd981d7-0b48-492e-8b31-21f5183a55de 61 fields · synced May 18, 2026
- EUDAMED 3d42a352-d5ac-49e4-a59a-ad5410e41212 61 fields · synced May 18, 2026
- EUDAMED 45d1109c-4e51-4b39-a6c2-4b6a5516e0c4 61 fields · synced May 18, 2026
- EUDAMED fe8b3f3f-0a84-44c4-87b6-41aeed995b00 61 fields · synced May 18, 2026
- EUDAMED 83fa262a-97ec-4eb5-87fa-4680e33a6563 61 fields · synced May 18, 2026
- EUDAMED 2dc55e62-f38e-48bd-aae8-d8d85097e1fe 61 fields · synced May 18, 2026
- EUDAMED 1174ff5e-e985-4ebd-957f-3d771107f765 61 fields · synced May 18, 2026
- EUDAMED f4c48849-8a5f-4e83-a95d-47dd6d4c5a5a 61 fields · synced May 18, 2026
- EUDAMED 26ed6c01-c012-4ad3-91b6-14c3710e64d1 61 fields · synced May 18, 2026
- EUDAMED 80dc190b-93b9-438b-ba01-ec9668dae364 61 fields · synced May 18, 2026
- EUDAMED 04c1942f-607e-4bee-a8d6-e00947f234da 61 fields · synced May 18, 2026
- EUDAMED 3a38a7fd-bd28-4afa-b7ab-27d9a993d0a5 61 fields · synced May 18, 2026
- EUDAMED 7e46270b-e22e-42c7-9297-e2d3e3f87afe 61 fields · synced May 18, 2026
- EUDAMED 82aab632-dd9b-43da-b0fd-1cd752defc61 61 fields · synced May 18, 2026
- EUDAMED 64cf6990-61ef-4c2c-a195-08660a9cf4a5 61 fields · synced May 18, 2026
- EUDAMED 2431b3e1-c897-4c07-9050-38996fabafbc 61 fields · synced May 18, 2026
- EUDAMED 6ac9b212-df44-413d-ae4a-893eec2d8a8b 61 fields · synced May 18, 2026
- EUDAMED 6274c067-c6a3-459a-b8d8-24c1bdd2d5b0 61 fields · synced May 18, 2026
- EUDAMED cf8363aa-e907-43cb-aef4-7e03f3c8246a 61 fields · synced May 18, 2026
- EUDAMED 6e98f2bf-42a3-4001-96c6-ebeca98409aa 61 fields · synced May 18, 2026
- EUDAMED 580fddda-785a-4a7b-b928-391649b9c7c2 61 fields · synced May 18, 2026
- EUDAMED 5c94d474-a903-4fca-85f6-ba663f8014f7 61 fields · synced May 18, 2026
- EUDAMED 91dddf27-06da-4019-af1d-eb913b5cd137 61 fields · synced May 18, 2026
- EUDAMED eb95de43-3f7e-4ba4-b7a7-bf512c5caf7c 61 fields · synced May 18, 2026
- EUDAMED ccca0f42-9893-49f0-9606-86e915318f5a 61 fields · synced May 18, 2026
- EUDAMED 2bda9433-50f9-495e-a66a-5317bdf3f810 61 fields · synced May 18, 2026
- EUDAMED 338947a6-b9e9-4894-b089-c400cb5341ae 61 fields · synced May 18, 2026
- EUDAMED 13e26fe5-c8e7-4941-aaaf-132a52971ccc 61 fields · synced May 18, 2026
- EUDAMED a852a38c-21fd-4cdf-9916-44e1b96f89eb 61 fields · synced May 18, 2026
- EUDAMED 8d0f2c56-f2c0-4358-aaaa-5e06e1224de2 61 fields · synced May 18, 2026
- EUDAMED 966d5d28-5e57-474c-845c-723cf980dc94 61 fields · synced May 18, 2026
- EUDAMED 413c383b-dba0-484d-b52b-72e557e696c5 61 fields · synced May 18, 2026
- EUDAMED a2a16fb5-cfa2-4412-a8f9-a7a605bdd855 61 fields · synced May 18, 2026
- EUDAMED c8957efd-6385-40e6-8899-4d9a6c2f57f6 61 fields · synced May 18, 2026
- EUDAMED 3267da18-dc04-4fba-9e3a-7193f42cd117 61 fields · synced May 19, 2026
- EUDAMED 5a6de8f9-56ba-4b1b-9e5b-bdd7fa00788b 61 fields · synced May 19, 2026
- EUDAMED 2ef14631-8e7d-4655-ac23-97e20574f521 61 fields · synced May 19, 2026
- EUDAMED d1b34d89-d0ba-4e7d-8548-7ba3c4292a8c 61 fields · synced May 19, 2026
- EUDAMED 8db90c8e-0654-4036-aa7d-6dd490e2943b 61 fields · synced May 19, 2026
- EUDAMED e6f734ab-7a49-4433-91b2-34ae8079fddf 61 fields · synced May 19, 2026
- EUDAMED a85c279d-e795-4d97-8d1e-f9186e84eabc 61 fields · synced May 19, 2026
- FDA UDI 468f1ee6-04bf-4af0-84b1-a47f53b54188 33 fields · synced May 30, 2026
- FDA UDI 6e7caf10-448b-4a60-9639-3b25e51d924b 33 fields · synced May 30, 2026
- FDA UDI ca49bb79-e89e-4a87-be1a-a545340f4673 33 fields · synced May 30, 2026
- EUDAMED f2301036-1f56-44b4-94ef-85d2b8f3f8cd 61 fields · synced Sep 30, 2026
- EUDAMED 31f1aa58-c112-4484-ab17-a58d88dc3fe9 61 fields · synced Sep 30, 2026