CreoDent Solidex Customized Abutment and Screw

K170100 · Creodent Prosthetics, Ltd. · NHA · Jul 18, 2017 · Dental

Device Facts

• Record ID: K170100
• Device Name: CreoDent Solidex Customized Abutment and Screw
• Applicant: Creodent Prosthetics, Ltd.
• Product Code: NHA · Dental
• Decision Date: Jul 18, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 endentulous. The device can be used for single or multiple-unit 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.

Device Story

Device consists of customized titanium alloy abutment and screw; used to support prosthetic restorations on endosseous dental implants. Abutment is customized to dentist specifications regarding wall thickness, diameter, height, and angulation (up to 20 degrees). Used in dental clinics by dentists; screw-retained to implant to provide stable base for cemented or screw-retained crowns/bridges. Benefits patient by restoring dental function and aesthetics in edentulous sites. Device is non-sterile; requires sterilization per ISO 17665-1 before use.

Clinical Evidence

Bench testing only. Static and dynamic fatigue testing performed per ISO 14801:2007E using worst-case connection platforms. Dimensional analysis conducted via reverse engineering of OEM components. Biocompatibility data leveraged from K150012.

Technological Characteristics

Material: Ti-6Al-4V Eli titanium alloy (ASTM F-136). Design: Customized abutment and screw for endosseous implants. Angulation: Up to 20 degrees from implant axis. Sterilization: ISO 17665-1 compliant. Mechanical: Dynamic fatigue tested per ISO 14801:2007E.

Indications for Use

Indicated for partially or completely edentulous patients requiring single or multiple-unit dental restorations supported by endosseous implants. Compatible with Sweden & Martina Premium Implant System (3.3mm and 3.8mm).

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 Abutments (K150012)
• Sweden & Martina Premium Implant System (K142242)

Submission Summary (Full Text)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird-like shape.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

CreoDent Prosthetics, Ltd. Calvin Shim Managing Director 29 West 30th Street 11th Floor New York, New York 10001 July 18, 2017

Re: K170100

Trade/Device Name: CreoDent Solidex® Customized Abutment and Screw Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: June 14, 2017 Received: June 20, 2017

Dear Calvin Shim:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Mary S. Runner -A

for Lori Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K170100

Device Name: CreoDent Solidex® Customized Abutment and Screw

Indication 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 endentulous. The device can be used for single or multiple-unit 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 and Screw are compatible with the following:

- Sweden & Martina Premium Implant System 3.3mm and 3.8mm ●
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-the-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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## 510(k) Summary

### CreoDent Prosthetics. Ltd. Solidex® Customized Abutment and Screw

### Submitter Information

Company Name: Company Address:

Company Telephone: Company Fax: Contact Person:

Date Summary Prepared:

CreoDent Prosthetics, Ltd. 29 West 30th Street, 11th Floor New York, New York 10001 [phone] [phone] Calvin Shim [phone] Oct 1, 2016

## DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:

Common Name:

Product Code: Classification Panel: Reviewing Branch:

CreoDent Solidex® Customized Abutment and Screw Endosseous Dental Implant Abutment, 21 CFR 872.3630 NHA Dental Products Panel Dental Devices Branch

## INDICATIONS FOR USE

The CreoDent Solidex® Customized Abutment and Screw is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely endentulous. The device can be used for single or multiple-unit 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 and Screw are compatible with the following:

- . Sweden & Martina Premium Implant System 3.3mm and 3.8mm

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# DEVICE DESCRIPTION

The Solidex® Customized Abutment and Screw is Ti-6A1-4V Eli titanium alloy meets ASTM F-136 standard and is designed to be screw retained for use with endosseous dental implants to provide support for a prosthetic restoration. These abutments are indicated for cement or screw retained restorations. Solidex® Customized Abutment and Screw are compatible with:

- . Sweden & Martina Premium Implant System 3.3mm and 3.8mm
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, height, collar height and angulation.

# EQUIVALENCE TO MARKETED DEVICE

The CreoDent Solidex® Customized Abutments are substantially equivalent in intended use, material, design and performance to:

- Creodent Solidex Customlized Abutments (K150012) Primary Predicate ●
- Sweden & Martina Premium Implant System (K142242)

# Conclusion:

The Creodent Solidex® Customized Abutment and Screw are substantially equivalent to the identified predicate products noted in this 510K Summary.

| Technological<br>Characteristics | CreoDent Solidex® Customized<br>Abutment and Abutment Screw | PRIMARY Predicate Device for<br>claimed equivalence: Creodent<br>Solidex Customized Abutment<br>(K150012) |
|----------------------------------|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | Abutment and Screw are Ti-6Al-4V Eli<br>titanium alloy meets ASTM F-136<br>Standard. | Abutment is Ti-6A1-4V Eli titanium<br>alloy meets ASTM F-136 Standard. It is<br>a higher grade material with more<br>tensile strength. The Screw is CP TI Gr4<br>meets ASTM F67 Standard. |
| Performance<br>Characteristics | Allows the prosthesis to be cemented or<br>screw retained to the abutment. The | Allows the prosthesis to be cemented<br>or screw retained to the abutment. The |

Table #1 Legally marketed predicate device (Abutment) to which equivalence is claimed:

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| | abutment screw is designed to secure the<br>abutment to the endosseous implant. | abutment screw is designed to secure<br>the abutment to the endosseous<br>implant. |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The CreoDent Solidex® Customized<br>Abutment and Screw is intended for use<br>with an endosseous implant to support a<br>prosthetic device in patients who are<br>partially or completely edentulous. The<br>device can be used for single or multiple-<br>unit restorations. The prosthesis can be<br>cemented or screw retained to the<br>abutment. An abutment screw is used to<br>secure the abutment to the endosseous<br>implant.<br><br>The CreoDent Solidex® Customized<br>Abutment and Screw are compatible with<br>the following:<br>Sweden & Martina Premium Implant<br>System 3.3mm and 3.8mm | The CreoDent Solidex® Customized<br>Abutment is intended for use with an<br>endosseous implant to support a<br>prosthetic device in patients who are<br>partially or completely edentulous. The<br>device can be used for single or multiple-<br>unit restorations. The prosthesis can be<br>cemented or screw retained to the<br>abutment. An abutment screw is used to<br>secure the abutment to the endosseous<br>implant.<br><br>The CreoDent Solidex® Customized<br>Abutment is compatible with the following:<br>Biomet 3i Osseotite Certain<br>Dental Implants 3.25mm, 4mm,<br>5mm, 6mm Straumann Bone Level implants<br>3.3mm, 4.1mm, 4.8mm |
| Dimensions<br>and<br>Angulations | Creodent Solidex Customized Abutment and<br>Screw sizes for<br>Sweden & Martina Premium Implant<br>System 3.3mm and 3.8mm Angles not to exceed up to 20 degrees from<br>the implant axis. | Creodent Solidex Customized Abutment<br>sizes for Biomet 3i Osseotite Certain<br>3.25mm, 4.0mm, 5.0mm and 6.0mm<br>diameter implants.<br>Straumann Bone Level implants 3.3mm,<br>4.1mm, 4.8mm<br><br>Angles not to exceed up to 20 degrees<br>from the implant axis. |

Non-clinical Testing Data: Static/Fatigue testing was conducted in accordance with ISO 14801:2007E Dentistry-Implants-Dynamic fatigue test for endosseous dental implants with the worst case scenario for the Solidex® Customized Abutment and Screw connection platform. Reverse engineering dimensional analysis was conducted using OEM implant bodies, OEM abutments and OEM abutment screws. Sterilization was conducted according to ISO 17665-1 was performed. These results demonstrated that the Solidex® Customized Abutment and Screw have sufficient mechanical strength for their intended clinical application and are compatible with the Sweden & Martina Premium Implant for which they are intended. Biocompatibility information is leveraged from our previous 510k (K150012).

Substantial Equivalence discussion differences between the subject device and the Primary predicate is the compatible implant bodies. This comparison is for implant compatibility.

Table #2 Legally marketed predicate device (Abutment) to which equivalence is claimed:

| Technological<br>Characteristics | CreoDent Solidex® Customized<br>Abutment and Abutment Screw | Reference Predicate Device for<br>claimed equivalence: Sweden &<br>Martina Premium Abutments<br>(K142242) |
|----------------------------------|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
|----------------------------------|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|

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| Material | Abutment and Screw are Ti-6A1-4V Eli<br>titanium alloy meets ASTM F-136<br>Standard. | -Abutment and Screw: Same Titanium<br>Alloy |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance<br>Characteristics | Allows the prosthesis to be cemented or<br>screw retained to the abutment. The<br>abutment screw is designed to secure the<br>abutment to the endosseous implant. | The prosthetics can be cemented,<br>screw retained or friction fit to the<br>abutment. |
| Indications for<br>Use | The CreoDent Solidex® Customized<br>Abutment and Screw is intended for use<br>with an endosseous implant to support a<br>prosthetic device in patients who are<br>partially or completely endentulous. The<br>device can be used for single or multiple-<br>unit restorations. The prosthesis can be<br>cemented or screw retained to the<br>abutment. An abutment screw is used to<br>secure the abutment to the endosseous<br>implant.<br>The CreoDent Solidex® Customized<br>Abutment and Screw are compatible with<br>the following:<br>Sweden & Martina Premium Implant<br>System 3.3mm and 3.8mm | The Premium abutments is intended<br>for us with an endossous implant to<br>support a prosthetic device in partially<br>or completely edentulous patient. It is<br>intended for use to support single and<br>multiple tooth prosthetic device in the<br>mandible or maxilla. The prosthetics<br>can be cemented, screw retained or<br>friction fit to the abutment. |
| Dimensions<br>and<br>Angulations | Creodent Solidex Customized Abutment and<br>Screw sizes for<br>Sweden & Martina Premium Implant<br>System 3.3mm and 3.8mm<br>Angles not to exceed up to 20 degrees from<br>the implant axis. | Sweden & Martina Premium<br>Implant System 3.3mm and 3.8mm<br>Stock abutments |

Non-clinical Testing Data: Static/Fatigue testing was conducted in accordance with ISO 14801:2007E Dentistry-Implants-Dynamic fatigue test for endosseous dental implants with the worst case scenario for the Solidex® Customized Abutment and Screw connection platform. Reverse engineering dimensional analysis was conducted using OEM implant bodies, OEM abutments and OEM abutment screws. Sterilization was conducted according to ISO 17665-1 was performed. These results demonstrated that the Solidex® Customized Abutment and Screw have sufficient mechanical strength for their intended clinical application and are compatible with the Sweden & Martina Premium Implant for which they are intended. Biocompatibility information is leveraged from our previous 510k (K150012).

Substantial Equivalence discussion differences: The only difference between the subject device and the reference predicate is that one is a stock abutment and Solidex is a Customized abutment. This difference is mitigated by fatigue testing, reverse engineering dimensional analysis.

# The CreoDent Solidex® Customized Abutment is compatible with the following:

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| Compatible Device | Implant Diameters | Implant Lengths |
|-------------------------------------|-------------------|-----------------|
| Sweden & Martina Premium<br>Implant | 3.3mm | 10mm |
| | | 11.5mm |
| | | 13mm |
| | | 15mm |
| | 3.8mm | 6mm |
| | | 7mm |
| | | 8.5mm |
| | | 8.5mm |
| | | 10mm |
| | | 11.5mm |
| | | 13mm |
| | | 15mm |

#### CONCLUSION:

Solidex Customized Abutments incorporates the same material, similar indications for use, dimension, design, abutment seat, screw seat, anatomical site, connection and technological characteristics as the predicate device (K150012). Both the subject and predicate device share intended use. The only significant difference between the devices is the implant platform compatibility which has been mitigated through dynamic fatigue testing and 300 party compatibility testing. The Solidex Customized abutments are substantially equivalent to the predicate (K150012).