Identity
- Trade Name
- Geo CMFit Abutment FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- 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
- Model / Reference
- CMFit14-DER-H2 FDA UDI
- 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
- 08800028712952 FDA UDI
- 510(k) Number
- K242978 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Dental implant suprastructure, permanent, preformed
Geo CMFit Abutment by Geomedi Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K242978 also covers:
- Geo CMFit Abutment — GEOMEDI INC.
- Geo CMFit Abutment — GEOMEDI INC.
- Geo CMFit Abutment — GEOMEDI INC.
- Geo CMFit Abutment — GEOMEDI INC.
- Geo CMFit Abutment — GEOMEDI INC.
- Geo CMFit Abutment — GEOMEDI INC.
- Geo CMFit Abutment — GEOMEDI INC.
- Geo CMFit Abutment — GEOMEDI INC.
- Geo CMFit Abutment — GEOMEDI INC.
- Geo CMFit Abutment — GEOMEDI INC.
- Geo CMFit Abutment — GEOMEDI INC.
- Geo CMFit Abutment — GEOMEDI INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Geomedi Inc.
Sources (1)
- FDA UDI f01e2af8-845e-4457-b74c-46d16b4b7a54 34 fields · synced May 30, 2026