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Geo CMFit Abutment
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Ref 102Model CMFit10-SURO-N2510(k) K242978
Identity
- Trade Name
- Geo CMFit Abutment FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Geo CMFit Abutment EUDAMEDGeo CMFit abutments are cylindrical titanium alloy abutments designed to be used for fabrication of a one-piece, all titanium patient-specific abutment by a CAD/CAM process. The portion of the abutment available for milling is either 9.9 mm in diameter by 20 mm in length or 13.9 mm in diameter by 20 mm in length. Geo CMFit abutments are available in engaging and non-engagingconnections. FDA UDI
- Model / Reference
- CMFit10-SURO-N2 EUDAMEDFDA UDI102 EUDAMED
- Description
- Geo CMFit abutments are cylindrical titanium alloy abutments designed to be used for fabrication of a one-piece, all titanium patient-specific abutment by a CAD/CAM process. The portion of the abutment available for milling is either 9.9 mm in diameter by 20 mm in length or 13.9 mm in diameter by 20 mm in length. Geo CMFit abutments are available in engaging and non-engagingconnections. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800028712884 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800028712884 EUDAMED
- 510(k) Number
- K242978 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
- Poland 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
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
Geo CMFit Abutment by GeoMedi Co., Ltd. — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242978 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08800028712884 | Class IIb | Active |
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Manufacturer
- Manufacturer
- GeoMedi Co., Ltd.
- EUDAMED SRN
- KR-MF-000008801
- FDA Applicant
- Geomedi Co,., Ltd.
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (3)
- EUDAMED 3055b7d5-9bd5-49e6-8653-fdd6fd81d3af 85 fields · synced Jun 18, 2026
- FDA UDI 64fff822-e7ac-49fa-8809-0d1601c9d49b 34 fields · synced May 30, 2026
- FDA 510(k) K242978 1 fields · synced May 19, 2026