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Multi Abutment (Multi Angled Abutment + Multi Angled Abutment Screw + Multi Ang…
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref MAASRH481755SRef MAASRN483055SRef MAASRN481735SRef MAASRH481745SRef MAASRN483065SRef MAASRN481755S
Identity
- Trade Name
- Multi Angled Abutment FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Multi Abutment (Multi Angled Abutment + Multi Angled Abutment Screw + Multi Angled Abutment Carrier) EUDAMED
- Model / Reference
- MAASRH481755S EUDAMEDFDA UDIMAASRN483065S EUDAMEDFDA UDIMAASRN483055S EUDAMEDFDA UDIMAASRH481745S EUDAMEDFDA UDIMAASRN481755S EUDAMEDFDA UDIMAASRN481735S EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800070222874 EUDAMEDFDA UDI08800070222997 EUDAMEDFDA UDI08800070222980 EUDAMEDFDA UDI08800070222867 EUDAMEDFDA UDI08800070222959 EUDAMEDFDA UDI08800070222935 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800070222874 EUDAMEDB-08800070222980 EUDAMEDB-08800070222935 EUDAMEDB-08800070222867 EUDAMEDB-08800070222997 EUDAMEDB-08800070222959 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 EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Multi Abutment (Multi Angled Abutment + Multi Angled Abutment Screw + Multi Ang… by Izenimplant Co., Ltd. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA…
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-08800070222874 | 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 (12)
- EUDAMED 063df0c3-7272-45e9-8f70-83dae9871931 61 fields · synced Jul 21, 2026
- FDA UDI 9cafd2ec-c9d9-4cc8-ba3e-062ac23385e1 33 fields · synced May 26, 2026
- FDA UDI 1b5ffae4-2eb7-4500-b02d-aded9381ed97 33 fields · synced May 29, 2026
- FDA UDI c5c6a3af-055b-4bcd-bf6b-7d88052007df 33 fields · synced May 30, 2026
- FDA UDI d6030832-4325-4639-a3a9-e812ae20ca84 33 fields · synced May 30, 2026
- FDA UDI d20b6427-3ef7-4724-bb98-a582c76e4024 33 fields · synced May 30, 2026
- FDA UDI 228e9083-a415-4d48-8375-628f3589dcf1 33 fields · synced May 30, 2026
- EUDAMED 8d261ab3-abff-4851-b2cd-b2bf826ee29d 61 fields · synced Jul 9, 2026
- EUDAMED 03679279-9051-4dc5-a79e-e5d6811012bc 61 fields · synced Jul 9, 2026
- EUDAMED 54b6e811-9648-4aaf-9b54-3d33f2136e24 61 fields · synced Jul 14, 2026
- EUDAMED 0fe4f11d-1f36-4898-941e-fbe25c6c5daa 61 fields · synced Jul 16, 2026
- EUDAMED d43da85f-e90e-4fb7-8159-729da17fd195 61 fields · synced Jul 21, 2026