(185 days)
No
The summary describes a customized dental abutment and screw, fabricated from titanium alloys. The customization is based on patient requirements specified by a dentist, and the manufacturing process involves digitally designed files sent to a validated facility. There is no mention of AI or ML being used in the design, customization, or manufacturing process. The performance studies focus on mechanical testing, dimensional analysis, sterilization, and biocompatibility, with no indication of AI/ML-driven analysis or interpretation.
No.
The device is an abutment and screw that supports a prosthetic device for partially or completely edentulous patients; it does not directly treat a disease or condition.
No
This device is a dental abutment, which is a prosthetic component used to support a dental restoration. Its intended use and device description indicate it is a restorative device, not a diagnostic one.
No
The device description clearly states that the device is fabricated from titanium alloy and is a physical abutment and screw, not a software product. While digital design files are mentioned, the final product is a physical medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for supporting a prosthetic device in patients who are partially or completely edentulous, used with an endosseous implant. This is a structural and mechanical function within the body.
- Device Description: The description details the materials (titanium alloy) and how it functions as a screw-retained abutment for dental implants.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
IVD devices are used to perform tests on samples like blood, urine, or tissue to diagnose diseases or conditions. This device is a physical component used in dental restoration.
N/A
Intended Use / 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 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 | Platform Diameter (mm) | Implant Body Diameter (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.
Product codes (comma separated list FDA assigned to the subject device)
NHA
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:
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.)
0
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
1
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
2
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 | Platform
Diameter (mm) | Implant Body
Diameter (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.
3
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
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 Floor
New York, New York 10001
Telephone: +1 212-302-3860 |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact
Email | Calvin Shim - Managing Director
calvin.shim@creodental.com |
| Representative/Consultant | Chris Brown, BSEE
Aclivi, LLC
3250 Brackley Drive
Ann Arbor, Michigan 48105
Telephone: +1 (810) 360-9773
E-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. |
5
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 | Platform
Diameter
(mm) | Implant Body
Diameter (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:
6
| Manufacturer | Implant Line | Platform
Diameter
(mm) | Implant Body
Diameter (mm) | Table 5A: Indications for Use Comparison with Predicate K162734 | | | | | | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|------------------------------|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|------------------------|----------------------------|----------------------|
| Altatec Biotechnolgies N.A. Incorporated | Camlog Screwline Implant Promote | 3.3 | 3.3 | Subject Device
CreoDent Solidex® Customized Abutment | | Predicate Device
CreoDent Solidex® Customized Abutment
K162734 | | | | |
| 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.
7
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
8
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® Customized | |||||||||||||||
| Abutment | CreoDent Solidex® Customized Abutment | CreoDent Solidex® Customized | |||||||||||||
| Abutment | CreoDent Solidex® Customized | ||||||||||||||
| Abutment | Parameter | Subject Device | |||||||||||||
| CreoDent Solidex® Customized | |||||||||||||||
| Abutment | Predicate Device | ||||||||||||||
| CreoDent Solidex® Customized | |||||||||||||||
| Abutment | |||||||||||||||
| K162734 | Reference Device | ||||||||||||||
| CreoDent Solidex® | |||||||||||||||
| Customized Abutment | |||||||||||||||
| K113738 | Reference Device | ||||||||||||||
| CreoDent Solidex® | |||||||||||||||
| Customized Abutment | |||||||||||||||
| K150012 | Reference Device | ||||||||||||||
| CreoDent Solidex® | |||||||||||||||
| Customized Abutment | |||||||||||||||
| K160436 | Substantial | ||||||||||||||
| Equivalence | |||||||||||||||
| K113738 | K150012 | K160436 | Product Code | NHA | NHA | NHA | NHA | NHA | Substantially | ||||||
| Equivalent | |||||||||||||||
| 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: |
(refer to compatibility
table listed in Table
5A above)
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 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:
• Nobel Replacem TiUnite Endlosseous
3.5mm, 4.3mm, and 5.0mm diameter
Implants (510K#023113)
• Nobel Active Internal Connection 3.5mm
and 4.3mm diameter
Implants(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 customized
to the requirements of each patient as may
be specified by the prescribing dentist. | The CreoDent Solidex®
Customized Abutment 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:
• Biomet 3i Osseotite Certain
Dental Implants 3.25mm, 4.0mm,
5.0mm, 6.0mm
• Straumann Bone Level Implants
3.3mm, 4.1mm, 4.8mm | The CreoDent Solidex®
Customized Abutment 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:
• Astra Tech Osseospeed TX
Implants 3.5mm, 4.5mm
• Hiossen TS Implants 3.5mm,
4.0mm | Regulation Number | 872.3630 | 872.3630 | 872.3630 | 872.3630 | 872.3630 | Substantially
Equivalent | | | | | |
| Regulatory Class | Class II | Class II | Class II | Class II | Class II | Substantially
Equivalent | | | | | | | | | |
| Abutment Material | Ti-6AL-4V ELI (Grade 23)
Camlog Screwline - 3.3,3.8,4.3,5.0
Astra Tech Osseospeed TX - 3.5, 4.5
Biomet 3i Certain - 3.25,4.0, 5.0, 6.0
Dentium 3.6 Implantium - 3.4
Hiossen TS - 3.5, 4.0
PrimaConnex (KeyStone) -
2.4,2.7,3.3
Straumann Bone Level - 3.3,4.1, 4.8
Thommen SPI Element -
3.5,4.0,4.2,5.0,6.0
CP TI (Commercially Pure Ti)
NobelActive - 3.5, 4.3
NobelReplace - 3.5,4.3,5.0
Zimmer - 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) | Substantially
Equivalent -
to Predicate,
and K113738,
K150012, and
K160436
Reference
devices | | | | | | | | | |
| Screw Material | Ti-6AL-4V ELI (Grade 23)
Camlog Screwline - 3.3,3.8,4.3,5.0
Dentium 3.6 Implantium - 3.4
PrimaConnex (KeyStone) -
2.4,2.7,3.3
NobelActive - 3.5, 4.3
NobelReplace - 3.5,4.3,5.0
Thommen SPI Element -
3.5,4.0,4.2,5.0,6.0
Zimmer - 3.7,4.7,6.0
CP TI (Commercially Pure Ti)
Astra Tech Osseospeed TX - 3.5, 4.5
Biomet 3i Certain - 3.25,4.0, 5.0, 6.0
Hiossen TS - 3.5, 4.0
Straumann 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) | Substantially
Equivalent -
to Predicate,
and K113738,
K150012, and
K160436
Reference
devices | | | | | | | | | |
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
9
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
10
| Method of Operation | | | | | | Substantially
Equivalent |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| | Allows the prosthesis to be
cemented or screw-retained to the
abutment. The abutment screw is
designed to secure the abutment to
the endosseous implant. | Allows the prosthesis to be
cemented or screw-retained to
the abutment. The abutment
screw is designed to secure the
abutment to the endosseous
implant. | Allows the prosthesis to be
cemented or screw-retained
to the abutment. The
abutment screw is designed
to secure the abutment to
the endosseous implant. | Allows the prosthesis to be
cemented or screw-retained
to the abutment. The
abutment screw is designed
to secure the abutment to
the endosseous implant. | Allows the prosthesis to be
cemented or screw-retained to
the abutment. The abutment
screw is designed to secure the
abutment to the endosseous
implant. | |
| Compatible Implant Systems -
Implant Diameter (mm) | Camlog Screwline - 3.3,3.8,4.3,5.0
Astra Tech Osseospeed TX - 3.5, 4.5
Biomet 3i Certain - 3.25,4.0, 5.0, 6.0
Dentium 3.6 Implantium - 3.4
Hiossen TS - 3.5, 4.0
PrimaConnex (KeyStone) –
2.4,2.7,3.3
NobelActive - 3.5, 4.3
NobelReplace - 3.5,4.3,5.0
Straumann Bone Level - 3.3,4.1, 4.8
Thommen SPI Element -
3.5,4.0,4.2,5.0,6.0
Zimmer – 3.7,4.7,6.0 | Camlog Screwline - 3.3,3.8,4.3,5.0
Ossespeed TX - 3.5, 4.5
Dentium 3.6 Implantium - 3.4
PrimaConnex (KeyStone) –
2.4,2.7,3.3
Thommen SPI Element -
3.5,4.0,4.2,5.0,6.0
(corrected from
2.8,3.5,3.5,4.3,5.3) | NobelActive – 3.5, 4.3
NobelReplace – 3.5,4.3,5.0
Zimmer – 3.7,4.7,6.0 | Biomet 3i Certain - 3.25,4.0,
5.0, 6.0
Straumann Bone Level –
3.3,4.1,4.8 | Astra Tech Osseospeed TX - 3.5,
4.5
Hiossen TS - 3.5, 4.0 | Substantially
Equivalent –
By means of
combining
Predicate and
Reference
device
compatible
implant
systems |
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.
11
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.
12
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.