(185 days)
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 screw is used to secure the abutment to the endosseous implant. The CreoDent Solidex® Customized Abutment is compatible with the following dental implants:
| Manufacturer | Implant Line | PlatformDiameter (mm) | Implant BodyDiameter (mm) |
|---|---|---|---|
| Altatec Biotechnolgies N.A. Incorporated | Camlog Screwline Implant Promote | 3.3 | 3.3 |
| Altatec Biotechnolgies N.A. Incorporated | Camlog Screwline Implant Promote | 3.8 | 3.8 |
| Altatec Biotechnolgies N.A. Incorporated | Camlog Screwline Implant Promote | 4.3 | 4.3 |
| Altatec Biotechnolgies N.A. Incorporated | Camlog Screwline Implant Promote | 5.0 | 5.0 |
| Astra Tech, Inc | Osseospeed TX Implants | 3.5 | 3.5 |
| Astra Tech, Inc | Osseospeed TX Implants | 4.5 | 4.5 |
| Biomet | 3i Osseotite Certain Dental Implants | 3.4 | 3.25 |
| Biomet | 3i Osseotite Certain Dental Implants | 4.1 | 4.0 |
| Biomet | 3i Osseotite Certain Dental Implants | 5.0 | 5.0 |
| Biomet | 3i Osseotite Certain Dental Implants | 6.0 | 6.0 |
| Dentium CO., Ltd | Dentium 3.6mm Implantium | 3.6 | 3.4 |
| Hiossen | Hiossen TS Implants | 3.5 (Mini) | 3.5 |
| Hiossen | Hiossen TS Implants | 4.0 (Regular) | 4.0 |
| Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | 3.5 | 2.4 |
| Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | 4.1 | 2.7 |
| Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | 5.0 | 3.3 |
| Nobel Biocare | NobelActive™ Internal Connection Implant | 3.5 (NP) | 3.5 |
| Nobel Biocare | NobelActive™ Internal Connection Implant | 3.9 (RP) | 4.3 |
| Nobel Biocare | NobelReplace™ TiUnite Endosseous Implant | 3.5 (NP) | 3.5 |
| Nobel Biocare | NobelReplace™ TiUnite Endosseous Implant | 4.3, 5.0 (RP) | 4.3, 5.0 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 3.5 | 3.5 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 4.0 | 4.0 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 4.5 | 4.2 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 5.0 | 5.0 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 6.0 | 6.0 |
| Straumann | Straumann Bone Level (BL) Implants | 3.3 (NC) | 3.3 |
| Straumann | Straumann Bone Level (BL) Implants | 4.1, 4.8 (RC) | 4.1, 4.8 |
| Zimmer | Zimmer Screw-Vent, Tapered Screw-Vent Implant | 3.5 | 3.7 |
| Zimmer | Zimmer Screw-Vent, Tapered Screw-Vent Implant | 4.5 | 4.7 |
| Zimmer | Zimmer Tapered Screw-Vent Implant | 5.7 | 6.0 |
All digitally designed files for CreoDent Solidex® Customized Abutment are to be sent back to a CreoDent-validated manufacturing facility for manufacture.
The CreoDent Solidex® Customized Abutment is fabricated of Ti-6AL-4V ELI titanium alloy meeting the requirements of ASTM F136 or Commercially Pure (CP Ti) titanium meeting the requirements of ASTM F67 (Grade 04-06). The CreoDent Solidex® Customized Abutment retention screws are fabricated of Ti-6AL-4V ELI titanium alloy meeting the requirements of ASTM F136 or Commercially Pure (CP Ti) titanium meeting the requirements of ASTM F67 (Grade 04-06). The CreoDent Solidex® Customized Abutment is 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. CreoDent Solidex® Customized Abutments are compatible with the following implant systems and the listed implant and restorative platform diameters:
| Manufacturer | Implant Line | PlatformDiameter(mm) | Implant BodyDiameter (mm) |
|---|---|---|---|
| Altatec Biotechnolgies N.A. Incorporated | Camlog Screwline Implant Promote | 3.3 | 3.3 |
| Altatec Biotechnolgies N.A. Incorporated | Camlog Screwline Implant Promote | 3.8 | 3.8 |
| Altatec Biotechnolgies N.A. Incorporated | Camlog Screwline Implant Promote | 4.3 | 4.3 |
| Altatec Biotechnolgies N.A. Incorporated | Camlog Screwline Implant Promote | 5.0 | 5.0 |
| Astra Tech, Inc | Osseospeed TX Implants | 3.5 | 3.5 |
| Astra Tech, Inc | Osseospeed TX Implants | 4.5 | 4.5 |
| Biomet | 3i Osseotite Certain Dental Implants | 3.4 | 3.25 |
| Biomet | 3i Osseotite Certain Dental Implants | 4.1 | 4.0 |
| Biomet | 3i Osseotite Certain Dental Implants | 5.0 | 5.0 |
| Biomet | 3i Osseotite Certain Dental Implants | 6.0 | 6.0 |
| Dentium CO., Ltd | Dentium 3.6mm Implantium | 3.6 | 3.4 |
| Hiossen | Hiossen TS Implants | 3.5 (Mini) | 3.5 |
| Hiossen | Hiossen TS Implants | 4.0 (Regular) | 4.0 |
| Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | 3.5 | 2.4 |
| Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | 4.1 | 2.7 |
| Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | 5.0 | 3.3 |
| Nobel Biocare | NobelActive™ Internal Connection Implant | 3.5 (NP) | 3.5 |
| Nobel Biocare | NobelActive™ Internal Connection Implant | 3.9 (RP) | 4.3 |
| Nobel Biocare | NobelReplace™ TiUnite Endosseous Implant | 3.5 (NP) | 3.5 |
| Nobel Biocare | NobelReplace™ TiUnite Endosseous Implant | 4.3, 5.0 (RP) | 4.3, 5.0 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 3.5 | 3.5 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 4.0 | 4.0 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 4.2 | 4.5 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 5.0 | 5.0 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 6.0 | 6.0 |
| Straumann | Straumann Bone Level (BL) Implants | 3.3 (NC) | 3.3 |
| Straumann | Straumann Bone Level (BL) Implants | 4.1, 4.8 (RC) | 4.1, 4.8 |
| Zimmer | Zimmer Screw-Vent, Tapered Screw-Vent Implant | 3.5 | 3.7 |
| Zimmer | Zimmer Screw-Vent, Tapered Screw-Vent Implant | 4.5 | 4.7 |
| Zimmer | Zimmer Tapered Screw-Vent Implant | 5.7 | 6.0 |
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. All digitally designed files for CreoDent Solidex® Customized Abutment are to be sent back to a CreoDent-validated manufacturing facility for manufacture.
The provided text describes the CreoDent Solidex® Customized Abutment, a dental implant abutment and screw designed to support prosthetic devices in partially or completely edentulous patients.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantifiable manner (e.g., specific thresholds for fatigue cycles or sterilization effectiveness). Instead, it states that "Test results and Biological Evaluation performed for the sponsor's Predicate and Reference devices demonstrate suitable biocompatibility of the Subject device" and that the testing demonstrated "sufficient mechanical strength for their intended clinical application."
The acceptance criteria seem to be implicitly tied to:
- Mechanical Strength: Sufficient to withstand dynamic fatigue loads as per ISO 14801:2007.
- Biocompatibility: Suitable for its intended use based on previous evaluations of predicate/reference devices.
- Sterilization: Effective sterilization according to ISO 17665-1.
- Dimensional Accuracy: Compatibility with various dental implant systems.
Given the information, a table would look like this:
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Mechanical Strength | Withstand dynamic fatigue as per ISO 14801:2007 for worst-case scenario. | "sufficient mechanical strength for their intended clinical application" |
| Biocompatibility | Suitable for intended medical use. | "suitable biocompatibility of the Subject device" (leveraged from previous submissions) |
| Sterilization | Achieve sterility according to ISO 17665-1. | "Sterilization according to ISO 17665-1 was performed" (leveraged from previous submissions) |
| Dimensional Accuracy/Compatibility | Accurate fit with specified implant systems. | "Reverse engineering dimensional analysis using OEM compatible implant bodies, abutments, and abutment fixation screws" (leveraged from previous submissions) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size for any of the non-clinical tests (static/fatigue testing, reverse engineering, sterilization, biocompatibility). It also does not explicitly state the country of origin or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. The testing described is non-clinical performance testing rather than studies involving expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided, as the studies are non-clinical performance tests, not studies requiring human expert adjudication for ground truth.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No such study was conducted or mentioned in the document. The device is a physical dental abutment, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable to a physical dental device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance tests:
- Mechanical Strength: The ground truth would be established by the physical testing results against the requirements of ISO 14801:2007.
- Biocompatibility: The ground truth would be established by the results of biological evaluation (e.g., cytotoxicity, sensitization, irritation tests) against relevant standards (e.g., ISO 10993).
- Sterilization: The ground truth would be established by successful validation of the sterilization process according to ISO 17665-1.
- Dimensional Accuracy/Compatibility: The ground truth would be established by physical measurements and fit testing using OEM compatible components.
8. The sample size for the training set
This is not applicable. The device is a physical product, not an AI/machine learning algorithm.
9. How the ground truth for the training set was established
This is not applicable. The device is a physical product, not an AI/machine learning algorithm.
Study Summaries:
The document states that "No new testing was performed as a part of this submission. Fatigue testing, reverse engineering, sterilization, and biocompatibility testing are all leveraged from previous submissions." This means the testing was conducted for earlier versions or similar devices (Predicate and Reference devices: K162734, K113738, K150012, K160436) and the results are considered applicable to the current submission due to substantial equivalence in design and materials.
-
Static/Fatigue Testing:
- Methodology: Conducted in accordance with ISO 14801:2007 (Dentistry - Implants - Dynamic fatigue test for endosseous dental implants) focusing on a "worst-case scenario" for the abutment connection platform.
- Purpose: To demonstrate sufficient mechanical strength for the intended clinical application.
-
Reverse Engineering Dimensional Analysis:
- Methodology: Used OEM compatible implant bodies, abutments, and abutment fixation screws.
- Purpose: To confirm the dimensional accuracy and compatibility of the CreoDent Solidex® Customized Abutment with various specified dental implant systems.
-
Sterilization:
- Methodology: Performed according to ISO 17665-1 (Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices).
- Purpose: To ensure the device can be effectively sterilized for safe clinical use.
-
Biological Evaluation:
- Methodology: Performed for the sponsor's Predicate and Reference devices. (Specific tests are not detailed, but typically involve ISO 10993 series for medical devices).
- Purpose: To ensure the materials used are biocompatible and do not pose unacceptable biological risks to patients.
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4/2/2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized depiction of an eagle, while the text reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The text is arranged in two lines, with "FDA U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.
CreoDent Prosthetics, Ltd. % Chris Brown, Manager Aclivi, LLC 6455 Farley Road Pinckney, Michigan 48169 USA
Re: K202909
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 26, 2021 Received: March 3, 2021
Dear Chris Brown:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531 -542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrl-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-ind-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Sherrill Lathrop Blitzer
for Andrew Steen Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202909
Device Name
CreoDent Solidex® Customized Abutment
Indications for Use (Describe)
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 screw is used to secure the abutment to the endosseous implant. The CreoDent Solidex® Customized Abutment is compatible with the following dental implants:
| Manufacturer | Implant Line | PlatformDiameter (mm) | Implant BodyDiameter (mm) |
|---|---|---|---|
| Altatec Biotechnolgies N.A. Incorporated | Camlog Screwline Implant Promote | 3.3 | 3.3 |
| Altatec Biotechnolgies N.A. Incorporated | Camlog Screwline Implant Promote | 3.8 | 3.8 |
| Altatec Biotechnolgies N.A. Incorporated | Camlog Screwline Implant Promote | 4.3 | 4.3 |
| Altatec Biotechnolgies N.A. Incorporated | Camlog Screwline Implant Promote | 5.0 | 5.0 |
| Astra Tech, Inc | Osseospeed TX Implants | 3.5 | 3.5 |
| Astra Tech, Inc | Osseospeed TX Implants | 4.5 | 4.5 |
| Biomet | 3i Osseotite Certain Dental Implants | 3.4 | 3.25 |
| Biomet | 3i Osseotite Certain Dental Implants | 4.1 | 4.0 |
| Biomet | 3i Osseotite Certain Dental Implants | 5.0 | 5.0 |
| Biomet | 3i Osseotite Certain Dental Implants | 6.0 | 6.0 |
| Dentium CO., Ltd | Dentium 3.6mm Implantium | 3.6 | 3.4 |
| Hiossen | Hiossen TS Implants | 3.5 (Mini) | 3.5 |
| Hiossen | Hiossen TS Implants | 4.0 (Regular) | 4.0 |
| Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | 3.5 | 2.4 |
| Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | 4.1 | 2.7 |
| Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | 5.0 | 3.3 |
| Nobel Biocare | NobelActive™ Internal Connection Implant | 3.5 (NP) | 3.5 |
| Nobel Biocare | NobelActive™ Internal Connection Implant | 3.9 (RP) | 4.3 |
| Nobel Biocare | NobelReplace™ TiUnite Endosseous Implant | 3.5 (NP) | 3.5 |
| Nobel Biocare | NobelReplace™ TiUnite Endosseous Implant | 4.3, 5.0 (RP) | 4.3, 5.0 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 3.5 | 3.5 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 4.0 | 4.0 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 4.5 | 4.2 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 5.0 | 5.0 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 6.0 | 6.0 |
| Straumann | Straumann Bone Level (BL) Implants | 3.3 (NC) | 3.3 |
| Straumann | Straumann Bone Level (BL) Implants | 4.1, 4.8 (RC) | 4.1, 4.8 |
| Zimmer | Zimmer Screw-Vent, Tapered Screw-Vent Implant | 3.5 | 3.7 |
| Zimmer | Zimmer Screw-Vent, Tapered Screw-Vent Implant | 4.5 | 4.7 |
| Zimmer | Zimmer Tapered Screw-Vent Implant | 5.7 | 6.0 |
All digitally designed files for CreoDent Solidex® Customized Abutment are to be sent back to a CreoDent-validated manufacturing facility for manufacture.
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X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K202909 510(k) Summary CreoDent Prosthetics, Ltd. CreoDent Solidex® Customized Abutment 4/2/2021
ADMINISTRATIVE INFORMATION
| Manufacturer Name | CreoDent Prosthetics, Ltd.29 West 30th Street, 11th FloorNew York, New York 10001Telephone: +1 212-302-3860 |
|---|---|
| Official ContactEmail | Calvin Shim - Managing Directorcalvin.shim@creodental.com |
| Representative/Consultant | Chris Brown, BSEEAclivi, LLC3250 Brackley DriveAnn Arbor, Michigan 48105Telephone: +1 (810) 360-9773E-mail: acliviconsulting@gmail.com |
| DEVICE NAME AND CLASSIFICATION | |
| Trade/Proprietary Name: | CreoDent Solidex® Customized Abutment |
| Common Name: | Abutment, Implant, Dental, Endosseous |
| Regulation Name: | Endosseous dental implant abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Device Class: | Class II |
| Review Panel: | Dental Products Panel |
|---|---|
| Reviewing Branch: | Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)Dental Devices (DHT1B) |
PREDICATE DEVICE INFORMATION
Product Code:
The Subject device in this submission is substantially equivalent in indications, intended use and design principles to the following Predicate device.
NHA
| 510(k) | Predicate Device Name | Company Name |
|---|---|---|
| K162734 | CreoDent Solidex® Customized Abutment | CreoDent Prosthetics, Ltd. |
The primary intent of this submission is to expand the Predicate device clearance to also include the following legally-marketed Reference device abutments and screws within a common Indications for Use which includes the statement that "digitally designed files for CreoDent Solidex® Customized Abutment are to be sent back to a CreoDent-validated manufacturing facility for manufacture."
| 510(k) | Reference Device Name | Company Name |
|---|---|---|
| K113738 | CreoDent Solidex® Customized Abutment | CreoDent Prosthetics, Ltd. |
| K150012 | CreoDent Solidex® Customized Abutment | CreoDent Prosthetics, Ltd. |
| K160436 | CreoDent Solidex® Customized Abutment | CreoDent Prosthetics, Ltd. |
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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 the abutment. An abutment. An abutment screw is used to secure the abutment to the endosseous implant. The CreoDent Solidex® Customized Abutment is compatible with the following dental implants:
| Manufacturer | Implant Line | PlatformDiameter(mm) | Implant BodyDiameter (mm) |
|---|---|---|---|
| Altatec Biotechnolgies N.A. Incorporated | Camlog Screwline Implant Promote | 3.3 | 3.3 |
| Altatec Biotechnolgies N.A. Incorporated | Camlog Screwline Implant Promote | 3.8 | 3.8 |
| Altatec Biotechnolgies N.A. Incorporated | Camlog Screwline Implant Promote | 4.3 | 4.3 |
| Altatec Biotechnolgies N.A. Incorporated | Camlog Screwline Implant Promote | 5.0 | 5.0 |
| Astra Tech, Inc | Osseospeed TX Implants | 3.5 | 3.5 |
| Astra Tech, Inc | Osseospeed TX Implants | 4.5 | 4.5 |
| Biomet | 3i Osseotite Certain Dental Implants | 3.4 | 3.25 |
| Biomet | 3i Osseotite Certain Dental Implants | 4.1 | 4.0 |
| Biomet | 3i Osseotite Certain Dental Implants | 5.0 | 5.0 |
| Biomet | 3i Osseotite Certain Dental Implants | 6.0 | 6.0 |
| Dentium CO., Ltd | Dentium 3.6mm Implantium | 3.6 | 3.4 |
| Hiossen | Hiossen TS Implants | 3.5 (Mini) | 3.5 |
| Hiossen | Hiossen TS Implants | 4.0 (Regular) | 4.0 |
| Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | 3.5 | 2.4 |
| Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | 4.1 | 2.7 |
| Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | 5.0 | 3.3 |
| Nobel Biocare | NobelActive™ Internal Connection Implant | 3.5 (NP) | 3.5 |
| Nobel Biocare | NobelActive™ Internal Connection Implant | 3.9 (RP) | 4.3 |
| Nobel Biocare | NobelReplace™ TiUnite Endosseous Implant | 3.5 (NP) | 3.5 |
| Nobel Biocare | NobelReplace™ TiUnite Endosseous Implant | 4.3, 5.0 (RP) | 4.3, 5.0 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 3.5 | 3.5 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 4.0 | 4.0 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 4.5 | 4.2 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 5.0 | 5.0 |
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 6.0 | 6.0 |
| Straumann | Straumann Bone Level (BL) Implants | 3.3 (NC) | 3.3 |
| Straumann | Straumann Bone Level (BL) Implants | 4.1, 4.8 (RC) | 4.1, 4.8 |
| Zimmer | Zimmer Screw-Vent, Tapered Screw-Vent Implant | 3.5 | 3.7 |
| Zimmer | Zimmer Screw-Vent, Tapered Screw-Vent Implant | 4.5 | 4.7 |
| Zimmer | Zimmer Tapered Screw-Vent Implant | 5.7 | 6.0 |
All digitally designed files for CreoDent Solidex® Customized Abutment are to be sent back to a CreoDent-validated manufacturing facility for manufacture.
DEVICE DESCRIPTION
The CreoDent Solidex® Customized Abutment is fabricated of Ti-6AL-4V ELI titanium alloy meeting the requirements of ASTM F136 or Commercially Pure (CP Ti) titanium meeting the requirements of ASTM F67 (Grade 04-06). The CreoDent Solidex® Customized Abutment retention screws are fabricated of Ti-6AL-4V ELI titanium alloy meeting the requirements of ASTM F136 or Commercially Pure (CP Ti) titanium meeting the requirements of ASTM F67 (Grade 04-06). The CreoDent Solidex® Customized Abutment is 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. CreoDent Solidex® Customized Abutments are compatible with the following implant systems and the listed implant and restorative platform diameters:
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| Manufacturer | Implant Line | PlatformDiameter(mm) | Implant BodyDiameter (mm) | Table 5A: Indications for Use Comparison with Predicate K162734 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Altatec Biotechnolgies N.A. Incorporated | Camlog Screwline Implant Promote | 3.3 | 3.3 | Subject DeviceCreoDent Solidex® Customized Abutment | Predicate DeviceCreoDent Solidex® Customized AbutmentK162734 | |||||
| Altatec Biotechnolgies N.A. Incorporated | Camlog Screwline Implant Promote | 3.8 | 3.8 | 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 CreoDent Solidex® Customized Abutment is compatible with the following dental implants: | 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® Customized Abutment is compatible with the following dental implants: | |||||
| Altatec Biotechnolgies N.A. Incorporated | Camlog Screwline Implant Promote | 4.3 | 4.3 | Manufacturer | Implant Line | Manufacturer | Implant Line | Platform Diameter (mm) | Implant Body Diameter (mm) | Implant Lengths (mm) |
| Altatec Biotechnolgies N.A. Incorporated | Camlog Screwline Implant Promote | 5.0 | 5.0 | Altatec Biotechnolgies N.A.Incorporated | Camlog Screwline Implant Promote | Altatec Biotechnolgies N.A.Incorporated | Camlog Screwline Implant Promote | 3.3 | 3.3 | 11,13,16 |
| Astra Tech, Inc | Osseospeed TX Implants | 3.5 | 3.5 | Altatec Biotechnolgies N.A.Incorporated | Camlog Screwline Implant Promote | Altatec Biotechnolgies N.A.Incorporated | Camlog Screwline Implant Promote | 3.8 | 3.8 | 9,11,13,16 |
| Astra Tech, Inc | Osseospeed TX Implants | 4.5 | 4.5 | Altatec Biotechnolgies N.A.Incorporated | Camlog Screwline Implant Promote | Altatec Biotechnolgies N.A.Incorporated | Camlog Screwline Implant Promote | 4.3 | 4.3 | 9,11,13,16 |
| Biomet | 3i Osseotite Certain Dental Implants | 3.4 | 3.25 | Altatec Biotechnolgies N.A.Incorporated | Camlog Screwline Implant Promote | Altatec Biotechnolgies N.A.Incorporated | Camlog Screwline Implant Promote | 5.0 | 5.0 | 9,11,13,16 |
| Biomet | 3 i Osseotite Certain Dental Implants | 4.1 | 4.0 | Astra Tech, Inc | Osseospeed TX Implants | Dentium CO., Ltd | Dentium 3.6mm Implantium | 3.6 | 3.4 | 8,10,12,14 |
| Biomet | 3 i Osseotite Certain Dental Implants | 5.0 | 5.0 | Astra Tech, Inc | Osseospeed TX Implants | Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 3.5 | 2.8 | 8,9.5,11,12.5,14,17 |
| Biomet | 3i Osseotite Certain Dental Implants | 6.0 | 6.0 | Biomet | 3i Osseotite Certain Dental Implants | Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 4.0 | 3.5 | 8,9.5,11,12.5,14,17 |
| Dentium CO., Ltd | Dentium 3.6mm Implantium | 3.6 | 3.4 | Biomet | 3i Osseotite Certain Dental Implants | Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 4.2 | 3.5 | 8,9.5,11,12.5,14,17 |
| Hiossen | Hiossen TS Implants | 3.5 (Mini) | 3.5 | Biomet | 3i Osseotite Certain Dental Implants | Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 5.0 | 4.3 | 8,9.5,11,12.5,14,17 |
| Hiossen | Hiossen TS Implants | 4.0 (Regular) | 4.0 | Biomet | 3i Osseotite Certain Dental Implants | Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 6.0 | 5.3 | 8,9.5,11,12.5,14,17 |
| Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | 3.5 | 2.4 | Dentium CO., Ltd | Dentium 3.6mm Implantium | 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 | Hiossen | Hiossen TS Implants | 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 | Hiossen | Hiossen TS Implants | Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | 5.0 | 3.3 | 8,10,11.5,13 |
| Nobel Biocare | NobelActive™ Internal Connection Implant | 3.5 (NP) | 3.5 | Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | |||||
| Nobel Biocare | NobelActive™ Internal Connection Implant | 3.9 (RP) | 4.3 | Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | |||||
| Nobel Biocare | NobelReplace™ TiUnite Endosseous Implant | 3.5 (NP) | 3.5 | Lifecore Biomedical, Inc | PrimaConnex Implants Internal (KeyStone) | |||||
| Nobel Biocare | NobelReplace™ TiUnite Endosseous Implant | 4.3, 5.0 (RP) | 4.3, 5.0 | Nobel Biocare | NobelActive™ Internal Connection Implant (NP) | |||||
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 3.5 | 3.5 | Nobel Biocare | NobelActive™ Internal Connection Implant (RP) | |||||
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 4.0 | 4.0 | Nobel Biocare | NobelReplace™ TiUnite Endosseous Implant | |||||
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 4.2 | 4.5 | Nobel Biocare | NobelReplace™ TiUnite Endosseous Implant | |||||
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 5.0 | 5.0 | Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | |||||
| Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | 6.0 | 6.0 | Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | |||||
| Straumann | Straumann Bone Level (BL) Implants | 3.3 (NC) | 3.3 | Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | |||||
| Straumann | Straumann Bone Level (BL) Implants | 4.1, 4.8 (RC) | 4.1, 4.8 | Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | |||||
| Zimmer | Zimmer Screw-Vent, Tapered Screw-Vent Implant | 3.5 | 3.7 | Thommen Medical AG | SPI Element Dental Implants RC INCELL PF | |||||
| Zimmer | Zimmer Screw-Vent, Tapered Screw-Vent Implant | 4.5 | 4.7 | Straumann | Straumann Bone Level (BL) Implants | |||||
| Zimmer | Zimmer Tapered Screw-Vent Implant | 5.7 | 6.0 | Straumann | Straumann Bone Level (BL) Implants | |||||
| Zimmer | Zimmer Screw-Vent, Tapered Screw-Vent Implant | |||||||||
| Zimmer | Zimmer Screw-Vent, Tapered Screw-Vent Implant | |||||||||
| Zimmer | Zimmer Tapered Screw-Vent Implant | |||||||||
| All digitally designed files for Creodent Solidex® Customized Abutment are to be sent back to a CreoDent-validated manufacturing facility for manufacture. |
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. All digitally designed files for CreoDent Solidex® Customized Abutment are to be sent back to a CreoDent-validated manufacturing facility for manufacture.
This submission contains no new compatibilities.
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EQUIVALENCE TO MARKETED DEVICE
The Subject device is substantially equivate device with respect to Indications for Use and technological principles. The comparison table below compare the Indications for Use and Technological Characteristics of the Subject and Predicate devices.
ludications for Use Camparia
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The Subject and Predicate devices are Substant, only differing in the list of compatible implant systems supporting a finding of Substantial Equivalence. The implant length column the compatibility table, as the implant and restorative platform diameters are the primary determining factors in compatibility. Differences in the list of compatible implant systems for each clearanded use of the device.
| Subject Device | Reference Device | Reference Device | Reference Device | Technical Characteristics Substantial Equivalence Comparison Table | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CreoDent Solidex® CustomizedAbutment | CreoDent Solidex® Customized Abutment | CreoDent Solidex® CustomizedAbutment | CreoDent Solidex® CustomizedAbutment | Parameter | Subject DeviceCreoDent Solidex® CustomizedAbutment | Predicate DeviceCreoDent Solidex® CustomizedAbutmentK162734 | Reference DeviceCreoDent Solidex®Customized AbutmentK113738 | Reference DeviceCreoDent Solidex®Customized AbutmentK150012 | Reference DeviceCreoDent Solidex®Customized AbutmentK160436 | SubstantialEquivalence | |||||
| K113738 | K150012 | K160436 | Product Code | NHA | NHA | NHA | NHA | NHA | SubstantiallyEquivalent | ||||||
| The CreoDent Solidex®Customized Abutment andscrew is intended for use withan endosseous implant tosupport a prosthetic device inpatients who are partially orcompletely edentulous. Thedevice can be used for single ormultiple restorations. Theprosthesis can be cemented orscrew retained to the abutment.An abutment screw is used tosecure the abutment to theendosseous implant. TheCreoDent Solidex® CustomizedAbutment is compatible withthe following dental implants:(refer to compatibilitytable listed in Table5A above)All digitally designed files forCreoDent Solidex® CustomizedAbutment are to be sent back toa CreoDent-validatedmanufacturing facility formanufacture. | 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 restorations.The prosthesis can be cemented or screwretained to the abutment. An abutmentscrew is used to secure the abutment tothe endosseous implant.The Solidex® Customized Abutment iscompatible with:• Nobel Replacem TiUnite Endlosseous3.5mm, 4.3mm, and 5.0mm diameterImplants (510K#023113)• Nobel Active Internal Connection 3.5mmand 4.3mm diameterImplants(5100K#071370)• Zimmer Screw-Vent 3.7mm, 4.7mm;Zimmer Tapered Screw-Vent 3.7mm,4.7mm and 6.0mm diameter Implants(510K#013227)The design of subject device is customizedto the requirements of each patient as maybe specified by the prescribing dentist. | The CreoDent Solidex®Customized Abutment isintended for use with anendosseous implant to support aprosthetic device in patients whoare partially or completelyedentulous. The device can beused for single or multiplerestorations. The prosthesis canbe cemented or screw retained tothe abutment. An abutmentscrew is used to secure theabutment to the endosseousimplant.The Solidex® CustomizedAbutment is compatible with thefollowing:• Biomet 3i Osseotite CertainDental Implants 3.25mm, 4.0mm,5.0mm, 6.0mm• Straumann Bone Level Implants3.3mm, 4.1mm, 4.8mm | The CreoDent Solidex®Customized Abutment isintended for use with anendosseous implant to support aprosthetic device in patients whoare partially or completelyedentulous. The device can beused for single or multiplerestorations. The prosthesis canbe cemented or screw retained tothe abutment. An abutmentscrew is used to secure theabutment to the endosseousimplant.The Solidex® CustomizedAbutment is compatible with thefollowing:• Astra Tech Osseospeed TXImplants 3.5mm, 4.5mm• Hiossen TS Implants 3.5mm,4.0mm | Regulation Number | 872.3630 | 872.3630 | 872.3630 | 872.3630 | 872.3630 | SubstantiallyEquivalent | |||||
| Regulatory Class | Class II | Class II | Class II | Class II | Class II | SubstantiallyEquivalent | |||||||||
| Abutment Material | Ti-6AL-4V ELI (Grade 23)Camlog Screwline - 3.3,3.8,4.3,5.0Astra Tech Osseospeed TX - 3.5, 4.5Biomet 3i Certain - 3.25,4.0, 5.0, 6.0Dentium 3.6 Implantium - 3.4Hiossen TS - 3.5, 4.0PrimaConnex (KeyStone) -2.4,2.7,3.3Straumann Bone Level - 3.3,4.1, 4.8Thommen SPI Element -3.5,4.0,4.2,5.0,6.0CP TI (Commercially Pure Ti)NobelActive - 3.5, 4.3NobelReplace - 3.5,4.3,5.0Zimmer - 3.7,4.7,6.0 | Ti-6AL-4V ELI (Grade 23) | CP TI (Commercially Pure Ti) | Ti-6AL-4V ELI (Grade 23) | Ti-6AL-4V ELI (Grade 23) | SubstantiallyEquivalent -to Predicate,and K113738,K150012, andK160436Referencedevices | |||||||||
| Screw Material | Ti-6AL-4V ELI (Grade 23)Camlog Screwline - 3.3,3.8,4.3,5.0Dentium 3.6 Implantium - 3.4PrimaConnex (KeyStone) -2.4,2.7,3.3NobelActive - 3.5, 4.3NobelReplace - 3.5,4.3,5.0Thommen SPI Element -3.5,4.0,4.2,5.0,6.0Zimmer - 3.7,4.7,6.0CP TI (Commercially Pure Ti)Astra Tech Osseospeed TX - 3.5, 4.5Biomet 3i Certain - 3.25,4.0, 5.0, 6.0Hiossen TS - 3.5, 4.0Straumann Bone Level - 3.3,4.1,4.8 | Ti-6AL-4V ELI (Grade 23) | Ti-6AL-4V ELI (Grade 23) | CP TI (Commercially Pure Ti) | CP TI (Commercially Pure Ti) | SubstantiallyEquivalent -to Predicate,and K113738,K150012, andK160436Referencedevices |
Table 5B: Indications for Use Comparison with Reference Devices
The Subject device Indications for Use statement compatible systems into a single statems into a single statement. The Subject and Reference device Indications for Use statements are highly similar, only differing in the lists of compatible implant systems and adding the statement clarifying digitally designed abutments are to a CreoDent-validated manufacturing facility for manufacture. The combined list of compatible implant systems of the Subject device the intended use of the device to support a dental prosthetic device. Specifying the
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manufacturing location does not change the device. Compatible system restorative platform diameters are now included in the Subject device compatibility table for additional clarity.
Tochnical Charactoristics Subctantial Equivalonco Comparison Tablo
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| Method of Operation | SubstantiallyEquivalent | |||||
|---|---|---|---|---|---|---|
| Allows the prosthesis to becemented or screw-retained to theabutment. The abutment screw isdesigned to secure the abutment tothe endosseous implant. | Allows the prosthesis to becemented or screw-retained tothe abutment. The abutmentscrew is designed to secure theabutment to the endosseousimplant. | Allows the prosthesis to becemented or screw-retainedto the abutment. Theabutment screw is designedto secure the abutment tothe endosseous implant. | Allows the prosthesis to becemented or screw-retainedto the abutment. Theabutment screw is designedto secure the abutment tothe endosseous implant. | Allows the prosthesis to becemented or screw-retained tothe abutment. The abutmentscrew is designed to secure theabutment to the endosseousimplant. | ||
| Compatible Implant Systems -Implant Diameter (mm) | Camlog Screwline - 3.3,3.8,4.3,5.0Astra Tech Osseospeed TX - 3.5, 4.5Biomet 3i Certain - 3.25,4.0, 5.0, 6.0Dentium 3.6 Implantium - 3.4Hiossen TS - 3.5, 4.0PrimaConnex (KeyStone) –2.4,2.7,3.3NobelActive - 3.5, 4.3NobelReplace - 3.5,4.3,5.0Straumann Bone Level - 3.3,4.1, 4.8Thommen SPI Element -3.5,4.0,4.2,5.0,6.0Zimmer – 3.7,4.7,6.0 | Camlog Screwline - 3.3,3.8,4.3,5.0Ossespeed TX - 3.5, 4.5Dentium 3.6 Implantium - 3.4PrimaConnex (KeyStone) –2.4,2.7,3.3Thommen SPI Element -3.5,4.0,4.2,5.0,6.0(corrected from2.8,3.5,3.5,4.3,5.3) | NobelActive – 3.5, 4.3NobelReplace – 3.5,4.3,5.0Zimmer – 3.7,4.7,6.0 | Biomet 3i Certain - 3.25,4.0,5.0, 6.0Straumann Bone Level –3.3,4.1,4.8 | Astra Tech Osseospeed TX - 3.5,4.5Hiossen TS - 3.5, 4.0 | SubstantiallyEquivalent –By means ofcombiningPredicate andReferencedevicecompatibleimplantsystems |
The abutment and screw material of the Reference devices are fabricated of either commercially pure titanium (CP Ti) or Ti-6AL-4V ELI (Grade 23) titanium. The materials are highly similar. Both materials and rental implant abutments and retention screws and have been validated through performance testing. The compatible implant systems of the Subject device does not change the intended use of the device to support a dental prosthetic device.
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Abutment Design Parameters (Dimensional Limitations) Comparison Table
| Subject Device - CreoDent Solidex® Customized Abutment | ||||||||
|---|---|---|---|---|---|---|---|---|
| Implant System | Max Diameter (mm) | Min Wall Thickness (mm) | Min Abutment Height (mm) | Max Abutment Height (mm) | Min Collar Height (mm) | Max Collar Height (mm) | Max Post Angulation (°) | Source Clearance |
| Ø - Restorative platform diameter | ||||||||
| Camlog Screwline Implant Promote | 5 | 0.68 | 5 | 10 | 1 | 5 | 20 | K162734 (P) |
| Astra Tech Osseospeed TX | 5 | 0.68 | 5 | 10 | 1 | 5 | 20 | K160436 (R) |
| Biomet 3i Osseotite Certain Ø3.4, 4.1, 5.0 mm | 5 | 0.68 | 5 | 10 | 1 | 5 | 20 | K150012 (R) |
| Biomet 3i Osseotite Certain Ø6mm | 5 | 0.74 | 5 | 10 | 1 | 5 | 20 | K150012 (R) |
| Dentium 3.6 mm Implantium | 5 | 0.68 | 5 | 10 | 1 | 5 | 20 | K162734 (P) |
| Hiossen TS | 5 | 0.68 | 5 | 10 | 1 | 5 | 20 | K160436 (R) |
| PrimaConnex Implant Internal (KeyStone) | 5 | 0.68 | 5 | 10 | 1 | 5 | 20 | K162734 (P) |
| NobelBiocare NobelActive Internal | 5 | 0.68 | 5 | 10 | 1 | 5 | 20 | K113738 (R) |
| NobelBiocare NobelReplace TiUnite | 5 | 0.68 | 5 | 10 | 1 | 5 | 20 | K113738 (R) |
| SPI Element Dental Implants RC INCELL PF Ø3.5, 4.0, 4.5 mm | 5 | 0.68 | 5 | 10 | 1 | 5 | 20 | K162734 (P) |
| SPI Element Dental Implants RC INCELL PF Ø5.0, 6.0 mm | 5 | 0.74 | 5 | 10 | 1 | 5 | 20 | K162734 (P) |
| Straumann Bone Level | 5 | 0.68 | 5 | 10 | 1 | 5 | 20 | K150012 (R) |
| Zimmer Screw-Vent, Tapered Screw-Vent | 5 | 0.68 | 5 | 10 | 1 | 5 | 20 | K113738 (R) |
| Predicate Device - CreoDent Solidex® Customized Abutment K162734 | ||||||||
| Implant System | Max Diameter (mm) | Min Wall Thickness (mm) | Min Abutment Height (mm) | Max Abutment Height (mm) | Min Collar Height (mm) | Max Collar Height (mm) | Max Post Angulation (°) | |
| Ø - Restorative platform diameter | ||||||||
| Camlog Screwline Implant Promote | 5 | 0.68 | 5 | 10 | 1 | 5 | 20 | |
| Dentium 3.6 mm Implantium | 5 | 0.68 | 5 | 10 | 1 | 5 | 20 | |
| PrimaConnex Implant Internal (KeyStone) | 5 | 0.68 | 5 | 10 | 1 | 5 | 20 | |
| SPI Element Dental Implants RC INCELL PF Ø3.5, 4.0, 4.5 mm | 5 | 0.68 | 5 | 10 | 1 | 5 | 20 | |
| SPI Element Dental Implants RC INCELL PF Ø5.0, 6.0 mm | 5 | 0.74 | 5 | 10 | 1 | 5 | 20 | |
| Reference Device - CreoDent Solidex® Customized Abutment K113738 | ||||||||
| Implant System | Max Diameter (mm) | Min Wall Thickness (mm) | Min Abutment Height (mm) | Max Abutment Height (mm) | Min Collar Height (mm) | Max Collar Height (mm) | Max Post Angulation (°) | |
| Ø - Restorative platform diameter | ||||||||
| NobelBiocare NobelActive Internal | 5 | 0.68 | 5 | 10 | 1 | 5 | 20 | |
| NobelBiocare NobelReplace TiUnite | 5 | 0.68 | 5 | 10 | 1 | 5 | 20 | |
| Zimmer Screw-Vent, Tapered Screw-Vent | 5 | 0.68 | 5 | 10 | 1 | 5 | 20 | |
| Reference Device - CreoDent Solidex® Customized Abutment K150012 | ||||||||
| Implant System | Max Diameter (mm) | Min Wall Thickness (mm) | Min Abutment Height (mm) | Max Abutment Height (mm) | Min Collar Height (mm) | Max Collar Height (mm) | Max Post Angulation (°) | |
| Ø - Restorative platform diameter | ||||||||
| Biomet 3i Osseotite Certain Ø3.4, 4.1, 5.0 mm | 5 | 0.68 | 5 | 10 | 1 | 5 | 20 | |
| Biomet 3i Osseotite Certain Ø6mm | 5 | 0.74 | 5 | 10 | 1 | 5 | 20 | |
| Straumann Bone Level | 5 | 0.68 | 5 | 10 | 1 | 5 | 20 | |
| Reference Device - CreoDent Solidex® Customized Abutment K160436 | ||||||||
| Implant System | Max Diameter (mm) | Min Wall Thickness (mm) | Min Abutment Height (mm) | Max Abutment Height (mm) | Min Collar Height (mm) | Max Collar Height (mm) | Max Post Angulation (°) | |
| Ø - Restorative platform diameter | ||||||||
| Astra Tech Osseospeed TX | 5 | 0.68 | 5 | 10 | 1 | 5 | 20 | |
| Hiossen TS | 5 | 0.68 | 5 | 10 | 1 | 5 | 20 |
Note: Dimensional limitations are applicable to all compatible implant restorative platform diameters unless otherwise noted.
The individual abutment design parameters of each in the Subject device is identical to individual abutment design parameters of each compatible implant system within the Predicate and Reference devices supporting a finding of substantial equivalence.
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Overall, the Technological Characteristics of the Subject device and that of the Predicate and Reference devices support a finding of Substantial Equivalence.
CLINICAL TESTING
No clinical data is included in this submission.
NON-CLINICAL PERFORMANCE TESTING
Static/Fatigue testing was conducted in accordance with ISO 14801:2007 Dentistry- Implants-Dynamic fatigue test for endosseous dental implants with the worst-case scenario for the CreoDent 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 CreoDent Solidex® Customized Abutment have sufficient mechanical strength for their intended clinical application.
Test results and Biological Evaluation performed for the sponsor's Predicate and Reference devices demonstrate suitable biocompatibility of the Subject device.
No new testing was performed as a part of this submission. Fatigue testing, reverse engineering, sterilization, and biocompatibility testing are all leveraged from previous submissions.
CONCLUSION
Overall, the Subject device has the following similarities to the legally marketed Predicate and Reference devices: The have nearly the same Indications for Use. They have same Intended Use. The have the same Technological Characteristics.
Overall, the Subject device and Predicate devices have been demonstrated to be 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.)