(220 days)
The CreoDent Solidex® Customized Abutment and Screw is intended for use with an endosseous implant to support a prosthetic device in patents who are partially or completely edentulous. The device can be used for single or multiple restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant.
The Solidex® Customized Abutment and Screw is Ti-6A1-4V Eli titanium alloy meets ASTM F-136 standard and is designed to be screw retained for use with endosseous dental implants to provide support for a prosthetic restoration. These abutments are indicated for cement or screw retained restorations. The design of subject device is customized to the requirements of each patient as may be specified by the prescribing dentist. Customization is limited by the minimum dimensions for wall thickness, diameter, post height, collar height and angulation.
The CreoDent Solidex® Customized Abutment is a dental device intended to support prosthetic devices with endosseous implants in partially or completely edentulous patients. The study aimed to demonstrate substantial equivalence to previously cleared predicate devices through non-clinical testing.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The information provided does not explicitly state numerical "acceptance criteria" for performance metrics in a pass/fail format typical of many medical device studies. Instead, substantial equivalence is established by demonstrating that the device has the same intended use, fundamental scientific technology, and comparable technological characteristics and performance to predicate devices, with any differences being "mitigated" or demonstrated to be safe and effective.
The provided document details comparisons between the CreoDent Solidex® Customized Abutment and several predicate devices across various technological characteristics. The "reported device performance" is primarily qualitative, asserting mechanical strength and compatibility, and is supported by specific non-clinical tests.
| Feature / Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance (as demonstrated by testing) |
|---|---|---|
| Material | Same as or comparable to predicate device materials (Ti-6Al-4V Eli titanium alloy, ASTM F-136 standard). | Abutment and Screw are Ti-6Al-4V Eli titanium alloy, meeting ASTM F-136 standard. (Same or higher grade than predicates). |
| Performance | Allows prosthesis to be cemented or screw-retained; abutment screw secures abutment to implant; sufficient mechanical strength. | Allows prosthesis to be cemented or screw-retained; abutment screw secures abutment to implant. Static/Fatigue testing per ISO 14801:2007E confirmed sufficient mechanical strength for intended clinical application. |
| Indications for Use | Same intended use as predicate devices (support prosthetic device with endosseous implant in partially/completely edentulous patients, single or multiple restorations). | Identical indications for use as primary predicate, and comparable to reference predicates. Compatibility with specific implant systems demonstrated. |
| Dimensions & Angulations | Comparable dimensions and angulations to predicate devices, with any differences not compromising safety/effectiveness. Max angulation up to 20 degrees from implant axis. | Customization limited by minimum dimensions (wall thickness, diameter, post height, collar height, angulation). Max angulation 20 degrees. Differences in angulation compared to some predicates (e.g., 30 degrees) were mitigated by testing. |
| Connection & Compatibility | Compatible with specific listed endosseous implant systems. | Compatibility explicitly stated and demonstrated with listed implant systems (Camlog, Thommen SPI Element, Dentium Implantium, Lifecore PrimaConnex). Reverse engineering dimensional analysis confirmed compatibility with OEM implant bodies. |
| Sterilization | Sterilized according to established standards. | Sterilization performed according to ISO 17665-1. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical testing rather than a clinical study with a "test set" of patient data.
- Sample Size for Non-clinical Testing: The document does not specify the exact number of physical samples (e.g., abutments, screws, implants) used for static/fatigue testing or reverse engineering dimensional analysis. It refers to "worst-case scenario" testing for the abutment connection platform.
- Data Provenance: The data is from non-clinical bench testing rather than human patient data. Therefore, there is no country of origin or retrospective/prospective classification in the typical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device's clearance is based on non-clinical testing and demonstration of substantial equivalence, not a clinical study requiring expert-established ground truth from patient data. The "ground truth" here is the adherence to mechanical performance standards and dimensional compatibility, verified by engineering and material science evaluations.
4. Adjudication Method for the Test Set
Not applicable, as there is no test set in the context of clinical images or data requiring adjudication by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or AI-assisted interpretation, which is not the nature of this dental abutment device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical dental device (abutment) and not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" in this context is established by:
- Mechanical Standards: Adherence to established international standards for dental implants and abutments (e.g., ISO 14801:2007E for dynamic fatigue).
- Material Specifications: Compliance with material standards (ASTM F-136 for Ti-6Al-4V Eli titanium alloy).
- Dimensional Compatibility: Verification through reverse engineering dimensional analysis against original equipment manufacturer (OEM) compatible implant bodies, abutments, and fixation screws.
- Sterilization Standards: Compliance with ISO 17665-1.
8. The Sample Size for the Training Set
Not applicable. This is a physical dental device; there is no "training set" in the machine learning sense. The design and manufacturing processes are likely informed by extensive engineering knowledge and design principles accumulated over time for similar devices.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/algorithm. For a physical device, the "ground truth" for design and manufacturing is established through engineering principles, material science, and adherence to accepted industry standards and regulatory requirements.
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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles. The symbol is black and stands out against the white background of the seal.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 8, 2017
CreoDent Prosthetics, Ltd. Mr. Calvin Shim Managing Director, CreoDent Prosthetics, Ltd. 29 West 30th Street, 11th Floor New York, New York 10001
Re: K162734
Trade/Device Name: CreoDent Solidex® Customized Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: February 24, 2017 Received: March 9, 2017
Dear Mr. Calvin Shim:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number K162734
Device Name: CreoDent Solidex® Customized Abutment
Indication for Use:
The CreoDent Solidex® Customized Abutment and Screw is intended for use with an endosseous implant to support a prosthetic device in patents who are partially or completely edentulous. The device can be used for single or multiple restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant. The Solidex Abutment is compatible with the following dental implants:
| Manufacturer | Implant Line | Platform Diameter (mm) | Body Diameter (mm) | Lengths (mm) |
|---|---|---|---|---|
| Altatec Biotechnolgies N.A. incorporated | Camlog Screwline Implant Promote | 3.3 | 3.3 | 11,13,16 |
| Altatec Biotechnolgies N.A. incorporated | Camlog Screwline Implant Promote | 3.8 | 3.8 | 9,11,13,16 |
| Altatec Biotechnolgies N.A. incorporated | Camlog Screwline Implant Promote | 4.3 | 3.8 | 9,11,13,16 |
| Altatec Biotechnolgies N.A. incorporated | Camlog Screwline Implant Promote | 5 | 4.3 | 9,11,13,16 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 3.5 | 2.8 | 8,9.5,11,12.5,14,17 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 4 | 3.5 | 8,9.5,11,12.5,14 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 4.2 | 3.5 | 8,9.5,11,12.5,14,17 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 5 | 4.3 | 8,9.5,11,12.5,14 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 6 | 5.3 | 8,9.5,11,12.5 |
| Dentium CO., Ltd | Dentium 3.6mm Implantium | 3.6 | 3.4 | 8,10,12,14 |
| Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | 3.5 | 2.4 | 10,11.5,13,15 |
| Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | 4.1 | 2.7 | 10,11.5,13,15 |
| Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | 5.0 | 3.3 | 8,10,11.5,13 |
All digitally designed files for Creodent Solidex Customzied Abutments are to be sent back to a Creodent validated manufacturing facility for manufacture.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) Summary
K162734
CreoDent Prosthetics, Ltd. Solidex® Customized Abutment
Submitter Information
Company Name: Company Address:
Company Telephone: Company Fax: Contact Person:
CreoDent Prosthetics, Ltd. 29 West 30th Street, 11tt Floor New York, New York 10001 (212) 302-3860 (212) 302-3865 Calvin Shim (212) 302-3860 May 8, 2017
Date Summary Prepared:
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: Common Name:
Product Code: Classification Panel: Reviewing Branch:
CreoDent Solidex® Customized Abutment Endosseous Dental Implant Abutment, 21 CFR 872.3630 NHA Dental Products Panel Dental Devices Branch
INDICATIONS FOR USE
The CreoDent Solidex® Customized Abutment and Screw is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely edentulous. The device can be used for single or multiple restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant.
The Solidex® Abutment is compatible with the following dental implants:
| Manufacturer | Implant Line | PlatformDiameter(mm) | BodyDiameter(mm) | Lengths (mm) |
|---|---|---|---|---|
| Altatec Biotechnolgies N.A.incorporated | Camlog Screwline Implant Promote | 3.3 | 3.3 | 11,13,16 |
| Altatec Biotechnolgies N.A.incorporated | Camlog Screwline Implant Promote | 3.8 | 3.8 | 9,11,13,16 |
| Altatec Biotechnolgies N.A.incorporated | Camlog Screwline Implant Promote | 4.3 | 3.8 | 9,11,13,16 |
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| Altatec Biotechnolgies N.A.incorporated | Camlog Screwline Implant Promote | 5 | 4.3 | 9,11,13,16 |
|---|---|---|---|---|
| Thommen Medical AG | SPI Element Dental Implants RC INCELLPF | 3.5 | 2.8 | 8,9.5,11,12.5,14,17 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELLPF | 4 | 3.5 | 8,9.5,11,12.5,14 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELLPF | 4.2 | 3.5 | 8,9.5,11,12.5,14,17 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELLPF | 5 | 4.3 | 8,9.5,11,12.5,14 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELLPF | 6 | 5.3 | 8,9.5,11,12.5 |
| Dentium CO., Ltd | Dentium 3.6mm Implantium | 3.6 | 3.4 | 8,10,12,14 |
| Lifecore Biomedical, Inc | PrimaConnex Implants Internal(KeyStone) | 3.5 | 2.4 | 10,11.5,13,15 |
| Lifecore Biomedical, Inc | PrimaConnex Implants Internal(KeyStone) | 4.1 | 2.7 | 10,11.5,13,15 |
| Lifecore Biomedical, Inc | PrimaConnex Implants Internal(KeyStone) | 5.0 | 3.3 | 8,10,11.5,13 |
All digitally designed files for Creodent Solidex Customzied Abutments are to be sent back to a Creodent validated manufacturing facility for manufacture.
DEVICE DESCRIPTION
The Solidex® Customized Abutment and Screw is Ti-6A1-4V Eli titanium alloy meets ASTM F-136 standard and is designed to be screw retained for use with endosseous dental implants to provide support for a prosthetic restoration. These abutments are indicated for cement or screw retained restorations. Solidex® Customized Abutments are compatible with:
| Manufacturer | Implant Line | PlatformDiameter(mm) | BodyDiameter(mm) | Lengths (mm) |
|---|---|---|---|---|
| Altatec Biotechnolgies N.A.incorporated | Camlog Screwline Implant Promote | 3.3 | 3.3 | 11,13,16 |
| Altatec Biotechnolgies N.A.incorporated | Camlog Screwline Implant Promote | 3.8 | 3.8 | 9,11,13,16 |
| Altatec Biotechnolgies N.A.incorporated | Camlog Screwline Implant Promote | 4.3 | 3.8 | 9,11,13,16 |
| Altatec Biotechnolgies N.A.incorporated | Camlog Screwline Implant Promote | 5 | 4.3 | 9,11,13,16 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELLPF | 3.5 | 2.8 | 8,9.5,11,12.5,14,17 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELLPF | 4 | 3.5 | 8,9.5,11,12.5,14 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELLPF | 4.2 | 3.5 | 8,9.5,11,12.5,14,17 |
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| Thommen Medical AG | SPI Element Dental Implants RC INCELLPF | 5 | 4.3 | 8,9.5,11,12.5,14 |
|---|---|---|---|---|
| Thommen Medical AG | SPI Element Dental Implants RC INCELLPF | 6 | 5.3 | 8,9.5,11,12.5 |
| Dentium CO., Ltd | Dentium 3.6mm Implantium | 3.6 | 3.4 | 8,10,12,14 |
| Lifecore Biomedical, Inc | PrimaConnex Implants Internal(KeyStone) | 3.5 | 2.4 | 10,11.5,13,15 |
| Lifecore Biomedical, Inc | PrimaConnex Implants Internal(KeyStone) | 4.1 | 2.7 | 10,11.5,13,15 |
| Lifecore Biomedical, Inc | PrimaConnex Implants Internal(KeyStone) | 5.0 | 3.3 | 8,10,11.5,13 |
The design of subject device is customized to the requirements of each patient as may be specified by the prescribing dentist. Customization is limited by the minimum dimensions for wall thickness, diameter, post height, collar height and angulation.
EQUIVALENCE TO MARKETED DEVICE
The CreoDent Solidex® Customized Abutments are substantially equivalent in intended use, material, design and performance to:
Primary Predicate:
Creodent Solidex® Customized Abutments (K150012)
Reference Predicates:
- Inclusive Titanium Abutments for Camlog (K121391)
- Atlantis Abutment for Keystone Implants (K103020)
- Dentium Implantium and Superline Abutments (K141457)
- Milling Abutment for CAD/CAM Dental Abutments (K151984)
Compatible Implant Systems Clearance numbers:
- Camlog Screwline Implant System (K022425)
- SPI ELEMENT dental Implants (K030689) ●
- Denitum Co., Ltd Implantium (K041368) ●
- PrimaConnex Internal Connection Implant System (K051614)
Comparison to the Predicates
The subject device is substantially equivalent in indications and design principles to the predicate devices shown above. Below are summary tables comparing the technological characteristics and the Indications for Use of the subject device abutments and the predicate device abutments.
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| TechnologicalCharacteristics | CreoDent Solidex® CustomizedAbutment and Abutment Screw | PRIMARY Predicate Device forclaimed equivalence: CreodentSolidex Customized Abutment(K150012) |
|---|---|---|
| Material | Abutment and Screw are Ti-6Al-4V Elititanium alloy meets ASTM F-136Standard. | Abutment is Ti-6Al-4V Eli titaniumalloy meets ASTM F-136 Standard. It isa higher grade material with moretensile strength. The Screw is CP TI Gr4meets ASTM F67 Standard. |
| PerformanceCharacteristics | Allows the prosthesis to be cemented orscrew retained to the abutment. Theabutment screw is designed to secure theabutment to the endosseous implant. | Allows the prosthesis to be cementedor screw retained to the abutment. Theabutment screw is designed to securethe abutment to the endosseousimplant. |
| Indications forUse | The CreoDent Solidex® CustomizedAbutment is intended for use with anendosseous implant to support a prostheticdevice in patients who are partially orcompletely edentulous. The device can beused for single or multiple-unit restorations.The prosthesis can be cemented or screwretained to the abutment. An abutment screwis used to secure the abutment to theendosseous implant.The CreoDent Solidex® CustomizedAbutment is compatible with the following:Camlog Screwline Implant Promte:3.3mm, 3.8mm, 4.3mm, 5.0mm SPI Element Dental Implants RCINCELL(Thommen): 3.5mm, 4.0mm,4.2mm, 5.0mm, 6.0mm Dentium Co., Ltd Implantium: 3.6mm Life Core Prima Connex InternalConnection Implant System Tapered(KeyStone): 3.5mm, 4.1mm, 5.0mm All digitally designed files for CreodentSolidex Customzied Abutments are to be sentback to a Creodent validated manufacturingfacility for manufacture. | The CreoDent Solidex® CustomizedAbutment is intended for use with anendosseous implant to support aprosthetic device in patients who arepartially or completely edentulous. Thedevice can be used for single or multiple-unit restorations. The prosthesis can becemented or screw retained to theabutment. An abutment screw is used tosecure the abutment to the endosseousimplant.The CreoDent Solidex® CustomizedAbutment is compatible with the following:Biomet 3i Osseotite CertainDental Implants 3.25mm, 4mm,5mm, 6mm Straumann Bone Level implants3.3mm, 4.1mm, 4.8mm |
| DimensionsandAngulations | Creodent Solidex Customized Abutment sizesfor Camlog Screwline Implant Promte:3.3mm, 3.8mm, 4.3mm, 5.0mm | Creodent Solidex Customized Abutmentsizes for Biomet 3i Osseotite Certain3.25mm, 4.0mm, 5.0mm and 6.0mmdiameter implants. |
| SPI Element Dental Implants RC INCELL(Thommen): 3.5mm, 4.0mm, 4.2mm, 5.0mm, 6.0mm Dentium Co., Ltd Implantium: 3.6mm Life Core Prima Connex Internal Connection Implant System Tapered (KeyStone): 3.5mm, 4.1mm, 5.0mm Angles not to exceed up to 20 degrees from the implant axis. | Straumann Bone Level implants 3.3mm, 4.1mm, 4.8mmAngles not to exceed up to 20 degrees from the implant axis. |
Table #1 Legally marketed predicate device (Abutment) to which equivalence is claimed:
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Non-clinical Testing Data: Static/Fatigue testing was conducted in accordance with ISO 14801:2007E Dentisty-Implants-Dynamic fatigue test for endosseous dental implants with the worst case scenario for the Solidex® Customized Abutment connection platform. Reverse engineering dimensional analysis using OEM compatible implant bodies, abutments, and abutment fixation screws. Sterilization according to ISO 17665-1 was performed. These results demonstrated that the Solidex® customized Abutment have sufficient mechanical strength for their intended clinical application.
Substantial Equivalence discussion difference: The differences between the subject device and the Primary predicate is the compatible implant bodies. This comparison is for similarity of device not for implant compatibility.
| Technological | CreoDent Solidex® Customized | Reference Predicate Device for |
|---|---|---|
| Characteristics | Abutment and Abutment Screw | claimed equivalence: Atlantis |
| Abutment for Camlog (K022425) | ||
| Material | Abutment and Screw are Ti-6A1-4V Elititanium alloy meets ASTM F-136Standard. | -Abutment and Screw: Same TitaniumAlloy |
| Performance | Allows the prosthesis to be cemented or | Allows the prosthesis to be cemented |
| Characteristics | screw retained to the abutment. Theabutment screw is designed to secure theabutment to the endosseous implant. | or screw retained to the abutment. Theabutment screw is designed to securethe abutment to the endosseousimplant. |
| Indications forUse | The CreoDent Solidex® CustomizedAbutment is intended for use with anendosseous implant to support a prostheticdevice in patients who are partially orcompletely edentulous. The device can beused for single or multiple-unit restorations.The prosthesis can be cemented or screwretained to the abutment. An abutment screwis used to secure the abutment to theendosseous implant.The CreoDent Solidex® CustomizedAbutment is compatible with the following:Camlog Screwline Implant Promte:3.3mm, 3.8mm, 4.3mm, 5.0mm | Altatec Biotechnologies implants areindicated for single tooth replacement,as immediate abutments on long spanto bridgework, as distal abutments onfree-end edentulous areas to berestored with fixed bridgework, tosupport overdentures in total orpartially edentulous arches, and asabutments supporting a full arch fixedprosthesis in the totally endentulousmandible or maxilla. |
Table #2 Legally marketed predicate device (Abutment) to which equivalence is claimed:
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| All digitally designed files for CreodentSolidex Customzied Abutments are to be sentback to a Creodent validated manufacturingfacility for manufacture. | ||
|---|---|---|
| DimensionsandAngulations | • Camlog Screwline Implant Promte:3.3mm, 3.8mm, 4.3mm, 5.0mm | • Camlog Screwline ImplantSystem: 3.3mm, 3.8mm, 4.3mm,5.0mm, 6.0mm |
| Angles not to exceed up to 20 degrees fromthe implant axis. | Angles not to exceed up to 30 degreesfrom the implant axis. |
Non-clinical Testing Data: Static/Fatigue testing was conducted in accordance with ISO 14801:2007E Dentistry-Implants-Dynamic fatigue test for endosseous dental implants with the worst case scenario for the Solidex® Customized Abutment connection platform. Reverse engineering dimensional analysis using OEM compatible implant bodies, abutments, and abutment fixation screws. Sterilization according to ISO 17665-1 was performed. These results demonstrated that the Solidex® customized Abutment have sufficient mechanical strength for their intended clinical application and are compatible with the Camlog Screwline Implant system for which they are intended.
Substantial Equivalence discussion differences: The only difference between the subject device and the reference predicate is the angulation. This difference is mitigated by fatigue testing, reverse engineering dimensional analysis.
| TechnologicalCharacteristics | CreoDent Solidex® CustomizedAbutment and Abutment Screw | Reference Predicate Device forclaimed equivalence: ThommenMilling Abutments for CAD/CAM(K151984) |
|---|---|---|
| Material | Abutment and Screw are Ti-6A1-4V Elititanium alloy meets ASTM F-136Standard. | -Abutment and Screw: Same TitaniumAlloy |
| PerformanceCharacteristics | Allows the prosthesis to be cemented orscrew retained to the abutment. Theabutment screw is designed to secure theabutment to the endosseous implant. | Allows the prosthesis to be cementedor screw retained to the abutment. Theabutment screw is designed to securethe abutment to the endosseousimplant. |
| Indications forUse | The CreoDent Solidex® CustomizedAbutment is intended for use with anendosseous implant to support a prostheticdevice in patients who are partially orcompletely edentulous. The device can beused for single or multiple-unit restorations.The prosthesis can be cemented or screwretained to the abutment. An abutment screwis used to secure the abutment to the | Thommen Milling abutments forCAD/CAM are intended to be used inconjunction with Thommen Systemdental implants in the maxillary and/ormandibular arch to provide support forcrowns, bridges, and over dentures.All digitally designed abutments foruse with Thommen Milling abutments |
Table #3 Legally marketed predicate device (Abutment) to which equivalence is claimed:
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| endosseous implant.The CreoDent Solidex® CustomizedAbutment is compatible with the following:• SPI Element Dental Implants RCINCELL(Thommen): 3.5mm, 4.0mm,4.2mm, 5.0mm, 6.0mmAll digitally designed files for CreodentSolidex Customzied Abutments are to besent back to a Creodent validatedmanufacturing facility for manufacture. | for CAD/CAM are intended to be sentto a Thommen validated milling centerfor manufacture. | |
|---|---|---|
| DimensionsandAngulations | Solidex Abutment sizes for• SPI Element Dental Implants RCINCELL(Thommen): 3.5mm, 4.0mm,4.2mm, 5.0mm, 6.0mmAngles not to exceed up to 20 degrees fromthe implant axis. | Thommen SPI Implants 3.5mm, 4.0mm,4.5mm, 5.0mm, 6.0mmAngles not to exceed up to 30 degreesfrom the implant axis. |
Non-clinical Testing Data: Static/Fatigue testing was conducted in accordance with ISO 14801:2007E Dentistry-Implants-Dynamic fatigue test for endosseous dental implants with the worst case scenario for the Solidex® Customized Abutment connection platform. Reverse engineering dimensional analysis using OEM compatible implant bodies, abutments, and abutment fixation screws. Sterilization according to ISO 17665-1 was performed. These results demonstrated that the Solidex® customized Abutment have sufficient mechanical strength for their intended clinical application and are compatible with the SPI Element Dental Implant (Thommen) system for which they are intended.
Substantial Equivalence discussion differences: The only difference between the subject device and the reference predicate is the angulation. This difference is mitigated by fatigue testing, reverse engineering dimensional analysis.
Table #4 Legally marketed predicate device (Abutment) to which equivalence is claimed:
| TechnologicalCharacteristics | CreoDent Solidex® CustomizedAbutment and Abutment Screw | Reference Predicate Device forclaimed equivalence: DentiumImplantium Dental Abutments(K052823) |
|---|---|---|
| Material | Abutment and Screw are Ti-6A1-4V Elititanium alloy meets ASTM F-136Standard. | -Abutment and Screw: ComparableTitanium |
| Performance | Allows the prosthesis to be cemented or | Allows the prosthesis to be cemented |
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| Characteristics | screw retained to the abutment. Theabutment screw is designed to secure theabutment to the endosseous implant. | or screw retained to the abutment. Theabutment screw is designed to securethe abutment to the endosseousimplant. |
|---|---|---|
| Indications forUse | The CreoDent Solidex® CustomizedAbutment is intended for use with anendosseous implant to support a prostheticdevice in patients who are partially orcompletely edentulous. The device can beused for single or multiple-unit restorations.The prosthesis can be cemented or screwretained to the abutment. An abutment screwis used to secure the abutment to theendosseous implant.The CreoDent Solidex® CustomizedAbutment is compatible with the following:• Dentium Co., Ltd Implantium: 3.6mmAll digitally designed files for CreodentSolidex Customzied Abutments are to be sentback to a Creodent validated manufacturingfacility for manufacture. | The Implantium abutments areintended to be used with Implantiumroot form endosseous dental implantto aid in prosthetic rehabilitationincluding overdenture retention. Afterthe root for endosseous dental implantis surgically placed, the endosseousdental implant abutment device isattached to it. |
| DimensionsandAngulations | Solidex Abutment sizes for• Dentium Co., Ltd Implantium: 3.6mmAngles not to exceed up to 20 degrees fromthe implant axis. | • Dentium Co., Ltd Implantium:3.6mm- 4.8mmAngles not to exceed up to 20 degrees fromthe implant axis. |
Non-clinical Testing Data: Static/Fatigue testing was conducted in accordance with ISO 14801:2007E Dentistry-Implants-Dynamic fatigue test for endosseous dental implants with the worst case scenario for the Solidex® Customized Abutment connection platform. Reverse engineering dimensional analysis using OEM compatible implant bodies, abutments, and abutment fixation validation according to ISO 17665-1 was performed. These results demonstrated that the Solidex® customized Abutment have sufficient mechanical strength for their intended clinical and are compatible with the Dentium Co., Ltd Implantium system for which thev are intended.
Substantial Equivalence discussion difference: The only differences between the subject device and the reference predicate is that Dentium abutments are stock abutments verse Solidex Customized Abutments.
Table #5 Legally marketed predicate device (Abutment) to which equivalence is claimed:
| TechnologicalCharacteristics | CreoDent Solidex® CustomizedAbutment and Abutment Screw | Reference Predicate Device forclaimed equivalence: Atlantis |
|---|---|---|
| Abutment for Keystone Implant(K103020) | ||
| Material | Abutment and Screw are Ti-6A1-4V Elititanium alloy meets ASTM F-136Standard. | -Abutment and Screw: Same TitaniumAlloy |
| PerformanceCharacteristics | Allows the prosthesis to be cemented orscrew retained to the abutment. Theabutment screw is designed to secure theabutment to the endosseous implant. | Allows the prosthesis to be cementedor screw retained to the abutment. Theabutment screw is designed to securethe abutment to the endosseousimplant. |
| Indications forUse | The CreoDent Solidex® CustomizedAbutment is intended for use with anendosseous implant to support a prostheticdevice in patients who are partially orcompletely edentulous. The device can beused for single or multiple-unit restorations.The prosthesis can be cemented or screwretained to the abutment. An abutment screwis used to secure the abutment to theendosseous implant.The CreoDent Solidex® CustomizedAbutment is compatible with the following:Life Core Prima Connex InternalConnection Implant System Tapered(KeyStone): 3.5mm, 4.1mm, 5.0mm All digitally designed files for CreodentSolidex Customzied Abutments are to be sentback to a Creodent validated manufacturingfacility for manufacture. | The Atlantis Abutment is intended foruse as an accessory to an endosseousimplant to support a prosthetic devicein a partially or completely edentulouspatient. It is intended for use tosupport single and multiple toothprosthesis, in the mandible or maxilla.The Prosthesis can be cement retainedto the abutment. The abutment screwis intended to secure the abutment tothe endosseous implant.This device is compatible with thefollowing manufacturers' implantsystems:The titanium abutments are compatiblewith the Keystone 3.5mm, 4.0mm,4.1mm and 5.0mm Keystone Implants.The zirconia abutments are compatiblewith the Keystone 3.5mm, 4.0mm,4.1mm and 5.0mm Keystone Implants.Please note: This device may be used inan early load situation, but is dependenton the specific implant system andprotocol used by the dental professional.Highly angled abutments on smalldiameter implants are intended for theanterior region only. |
| DimensionsandAngulations | Life Core Prima Connex InternalConnection Implant System Tapered(KeyStone): 3.5mm, 4.1mm, 5.0mm | Life Core Prima Connex InternalConnection Implant System(KeyStone): 3.5mm, 4.1mm,5.0mm |
| Angles not to exceed up to 20 degrees from | Angles not to exceed up to 30 degrees | |
| the implant axis. | from the implant axis. |
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Non-clinical Testing Data: Static/Fatigue testing was conducted in accordance with ISO 14801:2007E Dentistry-Implants-Dynamic fatigue test for endosseous dental implants with the worst case scenario for the Solidex® Customized Abutment connection platform. Reverse engineering dimensional analysis using OEM compatible implant bodies, abutments, and abutment fixation screws. Sterilization according to ISO 17665-1 was performed. These results demonstrated that the Solidex® customized Abutment have sufficient mechanical strength for their intended clinical application and are compatible with the Life Core Prima Connex Internal Connection Implant System for which they are intended.
Substantial Equivalence discussion: The only difference between the subject device and the reference predicate is the angulation. This difference is mitigated by fatigue testing, reverse engineering dimensional analysis.
| Compatible Device | Implant Diameters | Implant Lengths |
|---|---|---|
| Camlog Screwline ImplantsPromote | 3.3mm | 11mm13mm16mm |
| Camlog Screwline ImplantsPromote | 3.8mm | 9mm11mm13mm16mm |
| Camlog Screwline ImplantsPromote | 4.3mm | 9mm11mm13mm16mm |
| Camlog Screwline ImplantsPromote | 5.0mm | 9mm11mm13mm16mm |
The CreoDent Solidex® Customized Abutment is compatible with the following:
| Compatible Device | Implant Diameters | Implant Lengths |
|---|---|---|
| SPI Element Dental Implants RCINCELL (Thommen) | 3.5mm | 8mm |
| 9.5mm | ||
| 11mm | ||
| 12.5mm | ||
| 14mm | ||
| 17mm | ||
| SPI Element Dental Implants RCINCELL (Thommen) | 4.0mm | 8mm |
| 9.5mm | ||
| 11mm | ||
| 12.5mm | ||
| 14mm | ||
| SPI Element Dental Implants RC | 4.2mm | 8mm |
| 9.5mm |
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| INCELL (Thommen) | 11mm | |
|---|---|---|
| 12.5mm | ||
| 14mm | ||
| 17mm | ||
| SPI Element Dental Implants RCINCELL (Thommen) | 5.0mm | 8mm |
| 9.5mm | ||
| 11mm | ||
| 12.5mm | ||
| 14mm | ||
| SPI Element Dental Implants RCINCELL (Thommen) | 6.0mm | 8mm |
| 9.5mm | ||
| 11mm | ||
| 12.5mm |
| Compatible Device | Implant Diameters | Implant Lengths |
|---|---|---|
| Dentium Co., Ltd Implantium: | 3.6mm | 8mm |
| 10mm | ||
| 12mm | ||
| 14mm |
| Compatible Device | Implant Diameters | Implant Lengths |
|---|---|---|
| Life Core Prima Connex InternalConnection Implant SystemTapered (KeyStone) | 3.5mm | 10mm |
| 11.5mm | ||
| 13mm | ||
| 15mm | ||
| Life Core Prima Connex InternalConnection Implant SystemTapered (KeyStone) | 4.1mm | 10mm |
| 11.5mm | ||
| 13mm | ||
| 15mm | ||
| Life Core Prima Connex InternalConnection Implant SystemTapered (KeyStone) | 5.0mm | 8mm |
| 10mm | ||
| 11.5mm | ||
| 13mm |
CONCLUSION:
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Solidex Customized Abutments incorporates the same material, similar indications for use, dimension, design, abutment seat, screw seat, anatomical site, connection, type of retention and technological characteristics as the predicate device. Both the subject and predicate device share intended use, namely to serve as an aid in prosthetic reconstructions, such as crowns and bridges Also both the predicate and subject devices are intended to be milled into patient specific abutments using CAD/CAM technology. The only difference is the implant platform which has been validated through fatigue testing and reverse engineering dimensional analysis. Any differences in technology characteristics are accompanied by information that demonstrated the device is substantially equivalent as the predicate. The Solidex Customized abutments constitute a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its predicate device. Therefore, Solidex Customized abutments and its predicate are substantially equivalent.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)