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CCM Cast Abutment
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref CCARRH4010SRef CCARRH4030SRef CCARRH4010Ref CCARRN4010SRef CCARRN4030SRef CCARRN4010Ref CCASRN4510Ref CCASXH4030SRef CCASXH4030Ref CCARRN4030Ref CCATRH4530SRef CCATRN4510Ref CCATRN4510S
Identity
- Trade Name
- CCM Cast Abutment EUDAMEDFDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- CCM Cast Abutment EUDAMED
- Model / Reference
- CCARRH4010S EUDAMEDCCARRH4030S EUDAMEDCCARRH4010 EUDAMEDCCARRN4010S EUDAMEDCCARRN4030S EUDAMEDCCARRN4010 EUDAMEDCCASRN4510 EUDAMEDFDA UDICCATRN4510S EUDAMEDFDA UDICCATRN4510 EUDAMEDFDA UDICCASXH4030S EUDAMEDFDA UDICCATRH4530S EUDAMEDFDA UDICCASXH4030 EUDAMEDFDA UDICCARRN4030 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800070220108 EUDAMED08800070220115 EUDAMED08800070219881 EUDAMED08800070220122 EUDAMED08800070220139 EUDAMED08800070219904 EUDAMED08800070219782 EUDAMEDFDA UDI08800070220085 EUDAMEDFDA UDI08800070219867 EUDAMEDFDA UDI08800070219959 EUDAMEDFDA UDI08800070220054 EUDAMEDFDA UDI08800070219737 EUDAMEDFDA UDI08800070219911 EUDAMED
- Basic UDI-DI
- B-08800070220108 EUDAMEDB-08800070220115 EUDAMEDB-08800070219881 EUDAMEDB-08800070220122 EUDAMEDB-08800070220139 EUDAMEDB-08800070219904 EUDAMEDB-08800070219782 EUDAMEDB-08800070219959 EUDAMEDB-08800070219737 EUDAMEDB-08800070219911 EUDAMEDB-08800070220054 EUDAMEDB-08800070219867 EUDAMEDB-08800070220085 EUDAMED
- 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
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
CCM Cast 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-08800070220108 | 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 (19)
- EUDAMED df77a89c-4f78-40eb-a30c-482b3c9b0c57 61 fields · synced Sep 18, 2026
- EUDAMED 86bc6af1-4998-4648-ba25-392910f62efb 61 fields · synced May 16, 2026
- EUDAMED 24042749-a3a3-4b34-9108-b23dccb2f417 61 fields · synced May 17, 2026
- EUDAMED 44dfa395-844e-482f-be4f-9ee7fea0c132 61 fields · synced May 18, 2026
- EUDAMED fbc82506-fd0b-40dc-9389-08162940dc52 61 fields · synced May 18, 2026
- EUDAMED 70a16bf0-5759-4052-a435-30df5c5a0430 61 fields · synced May 18, 2026
- EUDAMED a6dad69e-cd19-4698-a64b-40653c4f4119 61 fields · synced May 18, 2026
- FDA UDI 2764cd08-c5b7-46d9-b114-f2d3d4e184cd 33 fields · synced May 29, 2026
- FDA UDI b4163cc2-a722-4a75-8f9f-54923abed519 33 fields · synced May 30, 2026
- FDA UDI 402a682d-8218-4516-ac5d-354874b698e9 33 fields · synced May 30, 2026
- FDA UDI 1e3ef083-9611-4781-8702-89d7fe16f47f 33 fields · synced May 30, 2026
- FDA UDI 899ef6d8-1b7f-4644-8919-840b5d0c50ba 33 fields · synced May 30, 2026
- FDA UDI 392b6964-50c5-4143-a8c4-eace3f7e56c4 33 fields · synced May 30, 2026
- EUDAMED 97f0c814-f722-4bfb-bb29-14c253edfb8c 61 fields · synced Jun 20, 2026
- EUDAMED 5bb42ae2-2c87-4312-8f42-d09e1b23f591 61 fields · synced Jul 8, 2026
- EUDAMED 36340be3-0dee-48e5-951b-43d9ce16dbeb 61 fields · synced Jul 9, 2026
- EUDAMED 8387f477-b392-465c-91e3-e7a2580ee117 61 fields · synced Jul 11, 2026
- EUDAMED a83e10bb-9a7f-459c-a530-759ba164cb7c 61 fields · synced Jul 20, 2026
- EUDAMED 41b3cad7-1eaa-4f35-91b4-40eedaeb9fdf 61 fields · synced Jul 30, 2026