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

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.

AI/ML Overview

The medical device under consideration is the CreoDent Solidex® Customized Abutment. The provided document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than proving a device meets specific acceptance criteria through a standalone clinical study. Therefore, some of the requested information, such as sample sizes for test/training sets, number/qualifications of experts for ground truthing, adjudication methods, and MRMC studies, is not typically part of a 510(k) submission for this type of device and is not present in the provided text.

Based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the CreoDent Solidex® Customized Abutment are implicitly derived from its substantial equivalence to predicate devices in material, indications for use, performance characteristics, and dimensions/angulations, backed by non-clinical testing. The performance is assessed against the established standards and the characteristics of the predicate devices.

Acceptance Criteria Category	Specific Acceptance Criteria (Derived from Predicate Equivalence)	Reported Device Performance (CreoDent Solidex® Customized Abutment)
Material	Abutment: Ti-6A1-4V Eli titanium alloy meets ASTM F-136 Standard. Screw: CP TI Gr4 meets ASTM F67 Standard. (Comparable to predicate materials)	Abutment: Ti-6A1-4V Eli titanium alloy meets ASTM F-136 Standard. Screw: CP TI Gr4 meets ASTM F67 Standard. (Reported as a higher grade material with more tensile strength than the predicate for the abutment, and comparable for the screw).
Performance Characteristics	Allows prosthesis to be cemented or screw-retained to the abutment, with the abutment screw securing it to the endosseous implant. (Comparable to predicate functionality).	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.
Indications for Use	Intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely edentulous, for single or multiple-unit restorations, cemented or screw-retained. Compatible with Astra Tech Osseospeed TX Implants 3.5mm, 4.5mm and Hiossen TS Implants 3.5mm, 4.0mm. (Comparable to predicate except for specific compatible implant bodies).	Intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely edentulous, for single or multiple-unit restorations, either cemented or screw retained. Compatible with Astra Tech Osseospeed TX Implants 3.5mm, 4.5mm and Hiossen TS Implants 3.5mm, 4.0mm.
Dimensions & Angulations	Personalized abutment design with minimum dimensions for wall thickness, diameter, height, collar height, and angulation. Angles not to exceed up to 20 degrees from the implant axis. (Compared to predicate's specific compatible implant sizes and angulation limits).	Customizable to patient requirements, limited by minimum dimensions. Abutment sizes for specified Astra Tech Osseospeed TX Implants (3.5mm, 4.5mm) and Hiossen TS Implants (3.5mm, 4.0mm). Angles not to exceed up to 20 degrees from the implant axis (for Astra Tech and Hiossen TS compatibility). This is a difference from one reference predicate which had 30 degrees angulation but is mitigated by testing.
Mechanical Strength & Compatibility	Sufficient mechanical strength for intended clinical application and compatibility with specified implant systems, as demonstrated by non-clinical testing (ISO 14801:2007E, reverse engineering, sterilization validation). This is the key performance "acceptance criteria" evaluated via testing.	Static/Fatigue testing in accordance with ISO 14801:2007E (worst-case scenario), reverse engineering dimensional analysis, and sterilization validation (ISO 17665-1) were performed. These results demonstrated that the Solidex® customized Abutment has sufficient mechanical strength and is compatible with the Astra Tech Osseospeed TX and Hiossen TS implant systems. This testing specifically addresses the differences in compatible implant bodies and angulation limitations compared to predicates.

Study Proving Acceptance Criteria:

The study proving the device meets its acceptance criteria is a non-clinical testing study focused on mechanical performance and compatibility.

Study Type: Non-clinical testing, specifically static/fatigue testing, reverse engineering dimensional analysis, and sterilization validation.
Standards Followed: ISO 14801:2007E (Dentistry-Implants-Dynamic fatigue test for endosseous dental implants) and ISO 17665-1 (Sterilization validation).
Purpose: To demonstrate that the CreoDent Solidex® Customized Abutment has sufficient mechanical strength for its intended clinical application and is compatible with the specified Astra Tech Osseospeed TX and Hiossen TS implant systems. This testing specifically addressed the differences identified when comparing to predicate devices (compatible implant bodies and angulation).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified in the document. Non-clinical mechanical testing typically involves a sufficient number of samples to ensure statistical significance for the specific test (e.g., number of abutment-implant assemblies tested for fatigue) but this exact number is not provided.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). As a non-clinical, in-vitro mechanical testing study, the data is generated in a laboratory setting.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This is a mechanical testing study, not one requiring expert human interpretation of medical images or patient data to establish ground truth. Therefore, this information is not applicable and not provided. The "ground truth" here is the physical performance of the device under defined test conditions per international standards.

4. Adjudication Method for the Test Set

Not applicable. As a mechanical testing study, adjudication of human interpretations is not involved.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not done. This type of study is for evaluating diagnostic or prognostic algorithms read by human experts, which is not relevant for this dental implant abutment.

6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study

Not applicable. This device is a physical medical device (an abutment for dental implants), not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is established through physical measurements and adherence to international mechanical testing standards (ISO 14801:2007E). The benchmarks are defined by these standards, the performance of the legally marketed predicate devices, and the physical properties of the materials and design.

8. Sample Size for the Training Set

Not applicable. This is a physical device, and the validation process described is for its mechanical integrity and compatibility, not for an algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable as there is no training set for a physical device like this.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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 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 (212) 302-3860 (212) 302-3865 Calvin Shim (212) 302-3860 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 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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Astra Tech Osseospeed TX Implants 3.5mm, 4.5mm (K024111)
. Hiossen TS Implants 3.5mm, 4.0mm (K151858)

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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TechnologicalCharacteristics	CreoDent Solidex® CustomizedAbutment and Abutment Screw	PRIMARY Predicate Device forclaimed equivalence: Creodent Solidex Customized Abutment(K150012)	TechnologicalCharacteristics	CreoDent Solidex® CustomizedAbutment and Abutment Screw	Reference Predicate Device forclaimed equivalence: Astra TechSystems (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 alloymeets ASTM F-136 Standard and Screw isCP TI Gr4 meets ASTM F67 Standard	-Abutment and Screw: ComparableTitanium Alloy
PerformanceCharacteristics	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.	PerformanceCharacteristics	Allows the prosthesis to be cemented orscrew retained to the abutment. Theabutment screw is designed to secure theabutment to the endosseous implant.	Astra Tech Implant system implants,abutments, prosthetic components andaccessories are intended forsupporting prosthetic devices inedentulous or partially edentulouspatients to restore esthetics andchewing function.
Indications forUse	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.The CreoDent Solidex® Customized Abutment is compatible with the following: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.The CreoDent Solidex® Customized Abutment is compatible with the following:Biomet 3i Osseotite Certain Dental Implants 3.25mm, 4mm, 5mm, 6mmStraumann Bone Level implants 3.3mm, 4.1mm, 4.8mm	Indications forUse	The CreoDent Solidex® CustomizedAbutment is intended for use with anendosseous implant to support a prostheticdevice in patients who are partially orcompletely edentulous. The device can beused for single or multiple-unit restorations.The prosthesis can be cemented or screwretained to the abutment. An abutment screwis used to secure the abutment to theendosseous implant.The CreoDent Solidex® CustomizedAbutment is compatible with the following:• Astra Tech Osseospeed TX Implants3.5mm, 4.5mm	Astra Tech Implant System is intendedto be used to replace missingmasticatory functional units (teeth) insingle or multiple unit applicationswithin the mandible or maxilla. Thedevice may be used equally well in asingle-stage or two-stage surgicalprocedure. It is indicated forimmediate implantation in extractionsites or implantation in partiallyhealed or completely healed alveolarridge situations.
DimensionsandAngulations	Creodent Solidex Customized Abutment sizes forAstra Tech Osseospeed TX Implants 3.5mm, 4.5mmHiossen TS Implants 3.5mm, 4.0mmAngles 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.Straumann Bone Level implants 3.3mm, 4.1mm, 4.8mmAngles not to exceed up to 20 degrees from the implant axis.	DimensionsandAngulations	• Astra Tech Osseospeed TX Implants3.5mm, 4.5mmAngles not to exceed up to 20 degrees fromthe implant axis.	• Astra Tech Osseospeed Implants3.0mm, 3.5mm, 4.0mm 4.5mm,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.

TechnologicalCharacteristics	CreoDent Solidex® CustomizedAbutment and Abutment Screw	Reference Predicate Device forclaimed equivalence: Hiossen ETSmart Fit Abutment (K123627)
Material	Abutment is Ti-6A1-4V Eli titanium alloymeets ASTM F-136 Standard and Screw isCP TI Gr4 meets ASTM F67 Standard	-Abutment and Screw: ComparableTitanium
PerformanceCharacteristics	Allows the prosthesis to be cemented orscrew retained to the abutment. Theabutment screw is designed to secure theabutment to the endosseous implant.	Allows the prosthesis to be cementedor screw retained to the abutment. Theabutment screw is designed to securethe abutment to the endosseousimplant.
Indications forUse	The CreoDent Solidex® CustomizedAbutment is intended for use with anendosseous implant to support a prostheticdevice in patients who are partially orcompletely edentulous. The device can beused for single or multiple-unit restorations.The prosthesis can be cemented or screwretained to the abutment. An abutment screwis used to secure the abutment to theendosseous implant.The CreoDent Solidex® CustomizedAbutment is compatible with the following:• Hiossen TS Implants 3.5mm, 4.0mm	ET SmartFit Abutment is intended foruse with a dental implant to providesupport for prosthetic restoration suchas crowns, bridges, or overdentures.
DimensionsandAngulations	Solidex Abutment sizes for• Hiossen TS Implants 3.5mm, 4.0mm	• Hiossen TS Implants 3.5mm,4.0mm
	Angles not to exceed up to 20 degrees fromthe implant axis.	Angles not to exceed up to 30 degreesfrom the implant axis.

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

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(K024111)	3.5mm	8mm
	3.5mm	9mm
	3.5mm	11mm
	3.5mm	13mm
	3.5mm	15mm
		17mm
Astra Tech Osseospeed TX.(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.

Regulation Number and Section

§ 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.)