CreoDent Solidex Custom Abutment

K160436 · Creodent Prosthetics, Ltd. · NHA · Sep 29, 2016 · Dental

Device Facts

• Record ID: K160436
• Device Name: CreoDent Solidex Custom Abutment
• Applicant: Creodent Prosthetics, Ltd.
• Product Code: NHA · Dental
• Decision Date: Sep 29, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 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 is compatible with the following: Astra Tech Osseospeed TX Implants 3.5mm, 4.5mm Hiossen TS Implants 3.5mm, 4.0mm

Device Story

Customized dental abutment; used with endosseous implants to support prosthetic restorations (crowns, bridges). Input: patient-specific anatomical requirements provided by prescribing dentist. Transformation: CAD/CAM milling of titanium alloy to create patient-specific geometry. Output: customized abutment secured to implant via abutment screw. Used in dental clinics by dentists. Benefits: provides patient-specific support for prosthetic restorations, restoring esthetics and chewing function.

Clinical Evidence

Bench testing only. Static and dynamic fatigue testing performed per ISO 14801:2007E to evaluate mechanical strength of the connection platform under worst-case scenarios. Reverse engineering dimensional analysis confirmed compatibility with specified implant fixtures. Sterilization validation performed per ISO 17665-1.

Technological Characteristics

Abutment: Ti-6Al-4V Eli titanium alloy (ASTM F-136). Screw: CP TI Gr4 (ASTM F-67). Design: patient-specific, CAD/CAM milled. Angulation: up to 20 degrees from implant axis. Sterilization: ISO 17665-1 compliant.

Indications for Use

Indicated for partially or completely edentulous patients requiring single or multiple-unit prosthetic restorations supported by endosseous dental implants. Compatible with Astra Tech Osseospeed TX (3.5mm, 4.5mm) and Hiossen TS (3.5mm, 4.0mm) implants.

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)

Reference Devices

• Astra Tech Implant Systems (K091239)
• Hiossen ET Smart Fit Abutment (K123627)
• Astra Tech Osseospeed TX Implants (K024111)
• Hiossen TS Implants (K151858)

Submission Summary (Full Text)

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Image /page/0/Picture/1 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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

September 29, 2016

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

Re: K160436

Trade/Device Name: CreoDent Solidex® Customized Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: August 31, 2016 Received: September 2, 2016

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

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

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

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

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

Sincerely,

Tina Kiang
-S

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K160436

Device Name: CreoDent Solidex® Customized Abutment

Indication for Use:

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 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 is compatible with the following:

- Astra Tech Osseospeed TX Implants 3.5mm, 4.5mm ●
- Hiossen TS Implants 3.5mm, 4.0mm ●

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

#### 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] August 31, 2016

## DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name:

Product Code: Classification Panel: Reviewing Branch:

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

# INDICATIONS FOR USE

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

- Astra Tech Osseospeed TX Implants 3.5mm, 4.5mm
- . Hiossen TS Implants 3.5mm, 4.0mm

#### DEVICE DESCRIPTION

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The Solidex® Customized Abutment is Ti-6A1-4V Eli titanium alloy meets ASTM F-136 Standard and Screw is CP TI Gr4 meets ASTM F67 and is designed to be screw retained for use with endosseous dental implants to provide support for a prosthetic restoration. These abutments are indicated for cement or screw retained restorations. Solidex® Customized Abutments are compatible with:

- Astra Tech Osseospeed TX Implants 3.5mm, 4.5mm (K024111)
- . Hiossen TS Implants 3.5mm, 4.0mm (K151858)

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:

- Primary Predicate Creodent Solidex Customlized Abutments (150012) .
- Reference Predicate Astra Tech Implant Systems (K091239)
- Reference Predicate Hiossen ET Smart Fit Abutment (K123627) ●

# Conclusion:

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

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| Technological<br>Characteristics | CreoDent Solidex® Customized<br>Abutment and Abutment Screw | PRIMARY Predicate Device for<br>claimed equivalence: Creodent Solidex Customized Abutment<br>(K150012) | Technological<br>Characteristics | CreoDent Solidex® Customized<br>Abutment and Abutment Screw | Reference Predicate Device for<br>claimed equivalence: Astra Tech<br>Systems (K091239) |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | Abutment is Ti-6A1-4V Eli titanium alloy meets ASTM F-136 Standard. It is a higher grade material with more tensile strength. The Screw is CP TI Gr4 meets ASTM F67 Standard. | Abutment is Ti-6A1-4V Eli titanium alloy meets ASTM F-136 Standard. It is a higher grade material with more tensile strength. The Screw is CP TI Gr4 meets ASTM F67 Standard. | Material | Abutment is Ti-6A1-4V Eli titanium alloy<br>meets ASTM F-136 Standard and Screw is<br>CP TI Gr4 meets ASTM F67 Standard | -Abutment and Screw: Comparable<br>Titanium Alloy |
| Performance<br>Characteristics | 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. | 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. | Astra Tech Implant system implants,<br>abutments, prosthetic components and<br>accessories are intended for<br>supporting prosthetic devices in<br>edentulous or partially edentulous<br>patients to restore esthetics and<br>chewing function. |
| Indications for<br>Use | 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-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.<br>The CreoDent Solidex® Customized Abutment is compatible with the following:<br>Astra Tech Osseospeed TX Implants 3.5mm, 4.5mmHiossen TS Implants 3.5mm, 4.0mm | 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-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.<br>The CreoDent Solidex® Customized Abutment is compatible with the following:<br>Biomet 3i Osseotite Certain Dental Implants 3.25mm, 4mm, 5mm, 6mmStraumann Bone Level implants 3.3mm, 4.1mm, 4.8mm | Indications for<br>Use | The CreoDent Solidex® Customized<br>Abutment is intended for use with an<br>endosseous implant to support a prosthetic<br>device in patients who are partially or<br>completely edentulous. The device can be<br>used for single or multiple-unit restorations.<br>The prosthesis can be cemented or screw<br>retained to the abutment. An abutment screw<br>is used to secure the abutment to the<br>endosseous implant.<br>The CreoDent Solidex® Customized<br>Abutment is compatible with the following:<br>• Astra Tech Osseospeed TX Implants<br>3.5mm, 4.5mm | Astra Tech Implant System is intended<br>to be used to replace missing<br>masticatory functional units (teeth) in<br>single or multiple unit applications<br>within the mandible or maxilla. The<br>device may be used equally well in a<br>single-stage or two-stage surgical<br>procedure. It is indicated for<br>immediate implantation in extraction<br>sites or implantation in partially<br>healed or completely healed alveolar<br>ridge situations. |
| Dimensions<br>and<br>Angulations | Creodent Solidex Customized Abutment sizes for<br>Astra Tech Osseospeed TX Implants 3.5mm, 4.5mmHiossen TS Implants 3.5mm, 4.0mm<br>Angles not to exceed up to 20 degrees from the implant axis. | Creodent Solidex Customized Abutment sizes for Biomet 3i Osseotite Certain 3.25mm, 4.0mm, 5.0mm and 6.0mm diameter implants.<br>Straumann Bone Level implants 3.3mm, 4.1mm, 4.8mm<br>Angles not to exceed up to 20 degrees from the implant axis. | Dimensions<br>and<br>Angulations | • Astra Tech Osseospeed TX Implants<br>3.5mm, 4.5mm<br>Angles not to exceed up to 20 degrees from<br>the implant axis. | • Astra Tech Osseospeed Implants<br>3.0mm, 3.5mm, 4.0mm 4.5mm,<br>5.0mm |

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

Non-clinical Testing Data: Static/Fatigue testing was conducted in accordance with ISO 14801:2007E Dentistry-Implants-Dynamic fatigue test for endosseous dental implants with the worst case scenario for the Solidex® Customized Abutment connection platform. Reverse engineering dimensional analysis using compatible implant fixtures and sterilization validation according to ISO 17665-1 was performed. These results demonstrated that the

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Solidex® customized Abutment have sufficient mechanical strength for their intended clinical application and are compatible with the Astra Tech Osseospeed Tx and Hiossen TS implant system for which they are intended.

Substantial Equivalence discussion Differences: The difference between the subject device and the Primary predicate is the compatible implant bodies. This difference is mitigated by fatigue testing reverse engineering dimensional analysis, and identification of reference predicate for compatible implant bodies.

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

Non-clinical Testing Data: Static/Fatique testing was conducted in accordance with ISO 14801:2007E Dentisty-Implants-Dynamic fatigue test for endosseous dental implants with the worst case scenario for the Solidex® Customized Abutment connection platform. Reverse engineering dimensional analysis using compatible implant fixtures and sterilization validation according to ISO 17665-1 was performed.These results demonstrated that the Solidex® customized Abutment have sufficient mechanical strength for their intended clinical and are compatible with the Astra Tech Osseospeed Tx Dental implant system for which they are intended.

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Substantial Equivalence Discussion Differences: The difference between the subject device and the reference predicate is the patient specific option of customizing the shape of the Reference Predicate is only stock abutments. This difference is mitigated by fatigue testing, reverse engineering dimensional analysis.

| Technological<br>Characteristics | CreoDent Solidex® Customized<br>Abutment and Abutment Screw | Reference Predicate Device for<br>claimed equivalence: Hiossen ET<br>Smart Fit Abutment (K123627) |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | Abutment is Ti-6A1-4V Eli titanium alloy<br>meets ASTM F-136 Standard and Screw is<br>CP TI Gr4 meets ASTM F67 Standard | -Abutment and Screw: Comparable<br>Titanium |
| 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. | Allows the prosthesis to be cemented<br>or screw retained to the abutment. The<br>abutment screw is designed to secure<br>the abutment to the endosseous<br>implant. |
| Indications for<br>Use | The CreoDent Solidex® Customized<br>Abutment is intended for use with an<br>endosseous implant to support a prosthetic<br>device in patients who are partially or<br>completely edentulous. The device can be<br>used for single or multiple-unit restorations.<br>The prosthesis can be cemented or screw<br>retained to the abutment. An abutment screw<br>is used to secure the abutment to the<br>endosseous implant.<br>The CreoDent Solidex® Customized<br>Abutment is compatible with the following:<br>• Hiossen TS Implants 3.5mm, 4.0mm | ET SmartFit Abutment is intended for<br>use with a dental implant to provide<br>support for prosthetic restoration such<br>as crowns, bridges, or overdentures. |
| Dimensions<br>and<br>Angulations | Solidex Abutment sizes for<br>• Hiossen TS Implants 3.5mm, 4.0mm | • Hiossen TS Implants 3.5mm,<br>4.0mm |
| | Angles not to exceed up to 20 degrees from<br>the implant axis. | Angles not to exceed up to 30 degrees<br>from the implant axis. |

Table #3 Legally marketed predicate device (Abutment) to which equivalence is claimed:

Non-clinical Testing Data: Static/Fatigue testing was conducted in accordance with ISO 14801:2007E Dentistry-Implants-Dynamic fatigue test for endosseous dental implants with the worst case scenario for the Solidex® Customized Abutment connection platform. Reverse engineering dimensional analysis using compatible implant fixtures and sterilization validation according to ISO 17665-1 was performed. These results demonstrated that the Solidex® customized Abutment have sufficient mechanical strength for their intended clinical and are compatible with the Hiossen TS implant system for which they are intended.

Substantial Equivalence Discussion Difference between the subject device and the reference predicate is the angulation. This difference is mitigated by fatigue testing, reverse engineering dimensional analysis.

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Table #3 Legally marketed predicate device (Implant) to which compatibility is claimed for the Solidex® Customized Abutment:

| Compatible Device | Implant Diameters | Implant Lengths |
|----------------------------------------|-------------------|-----------------|
| Astra Tech Osseospeed TX<br>(K024111) | 3.5mm | 8mm |
| | 3.5mm | 9mm |
| | 3.5mm | 11mm |
| | 3.5mm | 13mm |
| | 3.5mm | 15mm |
| | | 17mm |
| Astra Tech Osseospeed TX.<br>(K024111) | 4.5mm | 9mm |
| | 4.5mm | 11mm |
| | 4.5mm | 13mm |
| | 4.5mm | 15mm |
| | 4.5mm | 17mm |

Table #4 Legally marketed predicate device (Implant) to which compatibility is claimed for the Solidex® Customized Abutment:

| Compatible Device | Implant Diameters | Implant Lengths |
|-------------------------------|-------------------|-----------------|
| Hiossen TS Implants (K151858) | 3.5mm | 8.5mm |
| Hiossen TS Implants (K151858) | 3.5mm | 10.0mm |
| Hiossen TS Implants (K151858) | 3.5mm | 11.5mm |
| Hiossen TS Implants (K151858) | 3.5mm | 13mm |
| Hiossen TS Implants (K151858) | 4.0mm | 8.5mm |
| Hiossen TS Implants (K151858) | 4.0mm | 10.0mm |
| Hiossen TS Implants (K151858) | 4.0mm | 11.5mm |
| Hiossen TS Implants (K151858) | 4.0mm | 13mm |

#### CONCLUSION:

Solidex Customized Abutments incorporates the same material, same indications for use, dimension, design, abutment seat, screw seat, anatomical site, connection and technological characteristics as the predicate device. Both the subject and predicate device share intended use, namely to serve as an aid in prosthetic reconstructions, such as crowns and bridges Also both the predicate and subject devices are intended to be milled into patient specific abutments using CAD/CAM technology. The only difference is the implant platform which has been validated through fatigue testing. There aren't any further variations between

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the two devices which would anyway impede the substantially equivalent decision. Any differences in technology characteristics are accompanied by information that demonstrated the device is substantially equivalent as the predicate and do not raise different questions of safety and effectiveness than the predicate. Conclusion The Solidex Customized abutments constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its predicate device. Therefore, Solidex Customized abutments and its predicate are substantially equivalent.