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510(k) Data Aggregation
(209 days)
The DIMPLO Implant System is intended for use in the maxilla or mandible of partially or fully edentulous patients to support single or multiple-unit restorations, including cemented, screw-retained, or overdenture restorations, as well as terminal or intermediate abutment support for fixed bridgework. It is intended for two-stage surgical procedures and may be used for immediate loading when good primary stability and appropriate occlusal loading conditions are achieved.
- Ø3.3 mm implants are for replacing maxillary lateral incisors and mandibular incisors with delayed loading only.
- Ø5.0 mm and larger implants are intended for delayed loading in the molar region.
All digitally designed custom components (including Ti-Base and Pre-milled Blanks) for use with the DIMPLO Implant System are to be manufactured at a DIMPLO validated milling center.
The DIMPLO Implant System consists of fixtures, abutments, and attachments designed for dental implant procedures.
Fixture: Made of unalloyed titanium (Grade 4, ASTM F67), these dental implants are available in a range of diameters and lengths to accommodate various clinical applications in the maxilla and mandible. The surface is treated with SLA (Sandblasted, Large grit, and Acid-etched) and provided sterile via gamma irradiation. Available in two platform sizes: Mini and Regular.
Abutment: These components aid in prosthetic restorations. This category includes Cover Screws, Healing Abutments, Temporary Abutments, Cemented Abutments, Angled Abutments, Ti-Base, Pre-milled Blanks, Screws, Multi-unit Abutments, Healing Caps, and Cylinders.
Attachments: Includes Locatus Male Cap and Locatus Retention Male. The Locatus Male Cap is made of titanium alloy (Ti-6Al-4V ELI), while the Locatus Retention Male is made of nylon.
Fixtures and cover screws are supplied sterile. All other abutments and attachments are provided non-sterile and must be sterilized by the end user before use.
Ti-Base consists of a two-piece abutment that includes a titanium base at the bottom and a zirconia superstructure (CAD/CAM patient-specific superstructure) at the top, composing the final abutment.
Superstructure and Bonding Materials
- Zirconia material: InCoris Zi (ZrO₂) (K123664, Sirona Dental Systems GmbH)
- Bonding agent: RelyX Unicem 2 Automix (K100756, 3M ESPE)
Design Envelope for Zirconia superstructure
| Dimensional Characteristics | Range/Limit |
|---|---|
| Post Angle (°) | 0~20 |
| Cuff Height (mm) | 0.5~5.0 |
| Abutment Post Height (mm) | 4.0~6.0 |
| Diameter (Ø , mm) | 5.0~8.0 |
| Wall Thickness (mm) | 0.4~ |
Design Envelope for Pre-milled Blank
| Dimensional Characteristics | Range/Limit |
|---|---|
| Post Angle (°) | 0~30 |
| Cuff Height (mm) | 0.5~6.0 |
| Abutment Post Height (mm) | 4.0~7.0 |
| Diameter (Ø , mm) | 3.5~6.5 |
| Wall Thickness (mm) | 0.4~ |
Note: Abutment Post Height is defined as the minimum cementable post height for single-unit restoration, measured as the height above the restorative margin.
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(90 days)
Meta G UCLA Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
The Meta G UCLA Abutment is used for prosthetic restoration. The Meta G UCLA Abutment consists of Meta G UCLA Abutment and abutment screws. The Meta G UCLA Abutment is made of CCM (ASTM F1537) and POM (ASTM F1855). The casting material to make prosthesis is also CCM. When cast a prosthesis with the Meta G UCLA Abutment, the post height above the transmucosal collar of the Meta G UCLA Abutment has to be taller than 4mm and maximum 7mm.
The Meta G UCLA Abutment has Hex, Non Hex connection. Hex-type abutment should be used for single unit restorations and is not recommended for multiple tooth restorations. Non Hex-type abutment is for multiunit restorations only. No angulation is to be incorporated into the cast final device and abutments should not be used on implants placed at an angle.
It is provided non-sterile, this should be user steam sterilized before use. The Meta G UCLA abutment is compatible with our own implant system.
- INNO SLA Submerged Implant System(K132242) by Cowellmedi Co., Ltd.
- INNO SLA Submerged Narrow Implant System (K231395) by Cowellmedi Co., Ltd.
The design envelope for the Meta G UCLA Abutment is as follows.
<Design limits - Meta G UCLA Abutment> Minimum Diameter: 4.5 mm (0.18 in) Minimum Thickness : 0.8mm Maximum Total Cuff Height : 4mm Minimum Total Cuff Height : 1mm Maximum Cuff Height of Casting CCM part : 3mm Minimum Cuff Height of Casting CCM part : 0mm Post height: minimum of 4mm and maximum of 7mm
<Design limits - Meta G UCLA Abutment (Narrow)> Minimum Diameter: 4.5 mm (0.18 in) Minimum Thickness : 0.93mm Maximum Total Cuff Height : 4mm Minimum Total Cuff Height : 1mm Maximum Cuff Height of Casting CCM part : 3mm Minimum Cuff Height of Casting CCM part : 0mm Post height: minimum of 4mm and maximum of 7mm
The provided document is a 510(k) summary for a medical device (Meta G UCLA Abutment) seeking clearance from the FDA. It does not describe a study proving the device meets acceptance criteria for an AI/ML powered device. Instead, it details the device's technical specifications, indications for use, and a comparison to predicate devices to demonstrate "substantial equivalence."
Therefore, I cannot fulfill your request for information on acceptance criteria and a study proving an AI/ML device meets them, as this document is not about an AI/ML device or its performance evaluation in that context. This document focuses on the mechanical and material properties of a dental abutment and its equivalence to previously cleared devices.
Here's why and what information is available (though not directly answering your prompt):
- Type of Device: The Meta G UCLA Abutment is an "Endosseous Dental Implant Abutment." This is a mechanical medical device, not an AI/ML powered one.
- Performance Data (Non-Clinical) - Section 7: This section outlines the tests performed to demonstrate the safety and equivalence of the mechanical device:
- Sterilization validation testing: In accordance with ISO 17665-1 and ISO 17665-2 for steam sterilization.
- Biocompatibility testing: In accordance with ISO 10993-3, 5, 10, 11.
- Biocompatibility of the abutment screw: Leveraged from a previously cleared submission (K201323).
- MR Environment Condition: A non-clinical worst-case MRI review was performed using scientific rationale and published literature to assess magnetically induced displacement force and torque.
These are standard regulatory requirements for this type of mechanical implant component, not acceptance criteria for an AI/ML algorithm's analytical performance (e.g., sensitivity, specificity, AUC).
If you have a document pertaining to an AI/ML powered device, I would be happy to analyze it according to your requested criteria.
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