CreoDent Solidex Customized Abutment

K202909 · Creodent Prosthetics, Ltd. · NHA · Apr 2, 2021 · Dental

Device Facts

• Record ID: K202909
• Device Name: CreoDent Solidex Customized Abutment
• Applicant: Creodent Prosthetics, Ltd.
• Product Code: NHA · Dental
• Decision Date: Apr 2, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The CreoDent Solidex® Customized Abutment and screw is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely edentulous. The device can be used for single or multiple restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant. The CreoDent Solidex® Customized Abutment is compatible with the following dental implants: [List of compatible implants provided in document]. All digitally designed files for CreoDent Solidex® Customized Abutment are to be sent back to a CreoDent-validated manufacturing facility for manufacture.

Device Story

Customized dental abutment; fabricated from Ti-6AL-4V ELI (ASTM F136) or Commercially Pure titanium (ASTM F67). Device supports prosthetic restorations (cement or screw-retained) on endosseous implants. Prescribing dentist specifies design requirements; CreoDent-validated facility manufactures device from digital files. Used in dental clinics; operated by dentists. Output is physical abutment; aids in restoring patient masticatory function and aesthetics. Substantial equivalence established via compatibility with previously cleared implant systems and leveraging existing mechanical/biocompatibility data.

Clinical Evidence

No clinical data included. Non-clinical performance testing included static/fatigue testing per ISO 14801:2007, reverse engineering dimensional analysis, and sterilization validation per ISO 17665-1. Biocompatibility is supported by data from predicate and reference devices.

Technological Characteristics

Materials: Ti-6AL-4V ELI (ASTM F136) or Commercially Pure titanium (ASTM F67). Energy source: N/A (mechanical). Form factor: Customized abutment with screw. Sterilization: ISO 17665-1. Connectivity: Digital file submission to manufacturing facility.

Indications for Use

Indicated for partially or completely edentulous patients requiring single or multiple dental restorations supported by endosseous implants. Compatible with specific implant systems from Altatec, Astra Tech, Biomet, Dentium, Hiossen, Lifecore, Nobel Biocare, Thommen, Straumann, and Zimmer.

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

• CreoDent Solidex® Customized Abutment (K162734)

Reference Devices

• CreoDent Solidex® Customized Abutment (K113738)
• CreoDent Solidex® Customized Abutment (K150012)
• CreoDent Solidex® Customized Abutment (K160436)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 | Platform<br>Diameter (mm) | Implant Body<br>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.

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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.<br>29 West 30th Street, 11th Floor<br>New York, New York 10001<br>Telephone: [phone] |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact<br>Email | Calvin Shim - Managing Director<br>[e-mail] |
| Representative/Consultant | Chris Brown, BSEE<br>Aclivi, LLC<br>3250 Brackley Drive<br>Ann Arbor, Michigan 48105<br>Telephone: [phone]<br>E-mail: [e-mail] |
| 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)<br>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 | Platform<br>Diameter<br>(mm) | Implant Body<br>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:

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| Manufacturer | Implant Line | Platform<br>Diameter<br>(mm) | Implant Body<br>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<br>CreoDent Solidex® Customized Abutment | | Predicate Device<br>CreoDent Solidex® Customized Abutment<br>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.<br>Incorporated | Camlog Screwline Implant Promote | Altatec Biotechnolgies N.A.<br>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.<br>Incorporated | Camlog Screwline Implant Promote | Altatec Biotechnolgies N.A.<br>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.<br>Incorporated | Camlog Screwline Implant Promote | Altatec Biotechnolgies N.A.<br>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.<br>Incorporated | Camlog Screwline Implant Promote | Altatec Biotechnolgies N.A.<br>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 | | | | | | | | | | | |
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