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CCM Abutment
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref AANCAH4012LRef AROCCMRO4111TRef ICA5512NTRef AANCAN4012L
Identity
- Trade Name
- CCM Abutment FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- CCM Abutment EUDAMEDØ4/ L=11/ Octa/ RC FDA UDIØ4/ L=12/ Hex FDA UDIØ4/ L=12/ Non-Hex FDA UDIExfeel Internal Ø5.5/ L=12/ Non-Octa FDA UDI
- Model / Reference
- AANCAH4012L EUDAMEDAROCCMRO4111T EUDAMEDICA5512NT EUDAMEDAANCAN4012L EUDAMEDAROCCMRO4111 FDA UDIAANCAH4012 FDA UDIAANCAN4012 FDA UDIICA5512N FDA UDI
- Description
- Ø4/ L=11/ Octa/ RC FDA UDIØ4/ L=12/ Hex FDA UDIØ4/ L=12/ Non-Hex FDA UDIExfeel Internal Ø5.5/ L=12/ Non-Octa FDA UDI
Identifiers
- Catalog Number
- AROCCMRO4111T FDA UDIAANCAH4012L FDA UDIAANCAN4012L FDA UDIICA5512NT FDA UDI
- Primary DI / UDI-DI
- 08806388201013 EUDAMEDFDA UDI08806388260089 EUDAMEDFDA UDI08806388201020 EUDAMEDFDA UDI08806388220342 EUDAMEDFDA UDI
- Basic UDI-DI
- 880972899100PH 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
- Netherlands 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
CCM Abutment by Megagen Implant Co. Ltd — 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 | 880972899100PH | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- MegaGen Implant Co., Ltd.
- EUDAMED SRN
- KR-MF-000009885
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (8)
- EUDAMED c0533c9d-05a1-420d-a845-58f5159a10c5 61 fields · synced Jul 30, 2026
- FDA UDI 7e0dc98c-5e62-401f-91c5-a028b777d05d 35 fields · synced May 30, 2026
- FDA UDI ee42dac9-8f44-4409-a665-599f1a48afaf 35 fields · synced May 30, 2026
- FDA UDI 3e9bcd8d-a8d5-4f9c-81d2-9efa33a5cb82 35 fields · synced May 30, 2026
- FDA UDI 336efb97-096d-4c31-be81-06f9f17ab1de 35 fields · synced May 30, 2026
- EUDAMED 4f12c2d8-ff05-442f-8419-97871fa72cbc 61 fields · synced Jul 8, 2026
- EUDAMED ec37e5ce-11ac-4a4b-ab54-cf440d7c9519 61 fields · synced Jul 14, 2026
- EUDAMED 2e421877-ce3b-4313-80af-a3c39f8e3425 61 fields · synced Jul 30, 2026