Identity
- Trade Name
- Geo Multibase Abutment FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Geo Multibase abutments are two-piece abutments in which the Geo Multibase Abutment comprises the first part of the two-piece abutment and a patient-specific zirconia superstructure comprises the second part; the assembly becoming a final finished medical device after cementation of the superstructure on the subject device abutment. They are provided in straight designs, and two (2) connection types: for single unit prostheses (engaging connection) and for bridge or multi-unit prostheses (non-engaging connection). FDA UDI
- Model / Reference
- LL2-SUM13-N2 FDA UDI
- Description
- Geo Multibase abutments are two-piece abutments in which the Geo Multibase Abutment comprises the first part of the two-piece abutment and a patient-specific zirconia superstructure comprises the second part; the assembly becoming a final finished medical device after cementation of the superstructure on the subject device abutment. They are provided in straight designs, and two (2) connection types: for single unit prostheses (engaging connection) and for bridge or multi-unit prostheses (non-engaging connection). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800028715045 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 Multibase Abutment by Geomedi Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, permanent, preformed.
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- Diamodent — Diamodent · Class II
- Cemented Abutment — POINTIMPLANT Co., Ltd. · Class II
- GS System — OSSTEM IMPLANT Co., Ltd. · Class II
- Temporary Abutment — Cybermed Inc. · Class II
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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 c7070940-38f9-4045-8806-a750eea29853 34 fields · synced May 30, 2026