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

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.

AI/ML Overview

The CreoDent Solidex® Customized Abutment and Screw is a dental device intended for use with endosseous implants to support prosthetic devices. The information provided outlines the acceptance criteria and the study that proves the device meets these criteria as part of a 510(k) premarket notification.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Material Conformance	Abutment and Screw are Ti-6A1-4V Eli titanium alloy meets ASTM F-136 Standard.
Mechanical Strength (Fatigue Testing)	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. These results demonstrated that the Solidex® Customized Abutment and Screw have sufficient mechanical strength for their intended clinical application.
Dimensional Analysis (Compatibility)	Reverse engineering dimensional analysis was conducted using OEM implant bodies, OEM abutments and OEM abutment screws. The device is compatible with Sweden & Martina Premium Implant System 3.3mm and 3.8mm (specific implant diameters and lengths as detailed in the document).
Sterilization Efficacy	Sterilization was conducted according to ISO 17665-1. (Detailed results not provided, but the statement implies successful completion).
Biocompatibility	Biocompatibility information is leveraged from their previous 510(k) (K150012). (Implicitly, the device material has been proven biocompatible in a prior submission).
Angle Limitation	Angles not to exceed up to 20 degrees from the implant axis (for customized abutments).
Substantial Equivalence (Overall)	The CreoDent Solidex® Customized Abutment and Screw are substantially equivalent to the identified predicate products (Creodent Solidex Customized Abutment (K150012) and Sweden & Martina Premium Implant System (K142242)) in intended use, material, design, and performance, with differences mitigated by testing. The differences in compatible implant bodies compared to their primary predicate were mitigated through dynamic fatigue testing and 300-party compatibility testing.

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

The document does not explicitly state a "test set" in terms of a patient population size for clinical data. The testing described is primarily non-clinical:

Non-clinical Testing Data: Static/Fatigue testing in accordance with ISO 14801:2007E. The sample sizes for these mechanical tests are not specified (e.g., number of abutments and screws tested).
Dimensional Analysis: Conducted using OEM implant bodies, OEM abutments, and OEM abutment screws. The number of samples for this analysis is not specified.

The data provenance is from non-clinical laboratory testing and reverse engineering dimensional analysis, rather than patient-derived data from a specific country, and is therefore not retrospective or prospective in the clinical sense.

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

This section is not applicable as the studies described are non-clinical (mechanical and dimensional testing) and do not involve human expert interpretation or ground truth establishment in the traditional sense of clinical imaging or diagnostic studies. The "ground truth" for these tests would be the established engineering standards (e.g., ISO 14801:2007E), and the manufacturing specifications for the device and compatible implants.

4. Adjudication Method for the Test Set

This section is not applicable for the reasons stated above. There was no "test set" requiring adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on the mechanical and material equivalence of a dental abutment and screw to an existing predicate device using non-clinical testing. It does not involve human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study in the context of an algorithm or AI was not done. This device is a physical medical device (dental abutment and screw), not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing was based on:

Industry Standards: ISO 14801:2007E for dynamic fatigue testing.
Manufacturer Specifications: OEM implant bodies, OEM abutments, and OEM abutment screws for reverse engineering dimensional analysis.
Regulatory Standards: ASTM F-136 for material composition (Ti-6A1-4V Eli titanium alloy).
Previous Biocompatibility Data: Leveraged from their previous 510(k) (K150012).

8. The Sample Size for the Training Set

This section is not applicable. The device is a physical dental implant component, not an AI or machine learning model that requires a training set.

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

This section is not applicable for the reasons stated above.

Summary

{0}------------------------------------------------

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.

{1}------------------------------------------------

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

{2}------------------------------------------------

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 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)

{3}------------------------------------------------

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 (212) 302-3860 (212) 302-3865 Calvin Shim (212) 302-3860 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 are compatible with the following:

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

{4}------------------------------------------------

DEVICE DESCRIPTION

. 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.

TechnologicalCharacteristics	CreoDent Solidex® CustomizedAbutment and Abutment Screw	PRIMARY Predicate Device forclaimed equivalence: CreodentSolidex Customized Abutment(K150012)
Material	Abutment and Screw are Ti-6Al-4V Elititanium alloy meets ASTM F-136Standard.	Abutment is Ti-6A1-4V Eli titaniumalloy meets ASTM F-136 Standard. It isa higher grade material with moretensile strength. The Screw is CP TI Gr4meets ASTM F67 Standard.
PerformanceCharacteristics	Allows the prosthesis to be cemented orscrew retained to the abutment. The	Allows the prosthesis to be cementedor screw retained to the abutment. The

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

{5}------------------------------------------------

	abutment screw is designed to secure theabutment to the endosseous implant.	abutment screw is designed to securethe abutment to the endosseousimplant.
Indications forUse	The CreoDent Solidex® CustomizedAbutment and Screw is intended for usewith an endosseous implant to support aprosthetic device in patients who arepartially or completely edentulous. Thedevice can be used for single or multiple-unit restorations. The prosthesis can becemented or screw retained to theabutment. An abutment screw is used tosecure the abutment to the endosseousimplant.The CreoDent Solidex® CustomizedAbutment and Screw are compatible withthe following:Sweden & Martina Premium ImplantSystem 3.3mm and 3.8mm	The CreoDent Solidex® CustomizedAbutment is intended for use with anendosseous implant to support aprosthetic device in patients who arepartially or completely edentulous. Thedevice can be used for single or multiple-unit restorations. The prosthesis can becemented or screw retained to theabutment. An abutment screw is used tosecure the abutment to the endosseousimplant.The CreoDent Solidex® CustomizedAbutment is compatible with the following:Biomet 3i Osseotite CertainDental Implants 3.25mm, 4mm,5mm, 6mm Straumann Bone Level implants3.3mm, 4.1mm, 4.8mm
DimensionsandAngulations	Creodent Solidex Customized Abutment andScrew sizes forSweden & Martina Premium ImplantSystem 3.3mm and 3.8mm Angles not to exceed up to 20 degrees fromthe implant axis.	Creodent Solidex Customized Abutmentsizes for Biomet 3i Osseotite Certain3.25mm, 4.0mm, 5.0mm and 6.0mmdiameter implants.Straumann Bone Level implants 3.3mm,4.1mm, 4.8mmAngles not to exceed up to 20 degreesfrom 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:

TechnologicalCharacteristics	CreoDent Solidex® CustomizedAbutment and Abutment Screw	Reference Predicate Device forclaimed equivalence: Sweden &Martina Premium Abutments(K142242)
----------------------------------	-------------------------------------------------------------	-----------------------------------------------------------------------------------------------------------

{6}------------------------------------------------

Material	Abutment and Screw are Ti-6A1-4V Elititanium alloy meets ASTM F-136Standard.	-Abutment and Screw: Same TitaniumAlloy
PerformanceCharacteristics	Allows the prosthesis to be cemented orscrew retained to the abutment. Theabutment screw is designed to secure theabutment to the endosseous implant.	The prosthetics can be cemented,screw retained or friction fit to theabutment.
Indications forUse	The CreoDent Solidex® CustomizedAbutment and Screw is intended for usewith an endosseous implant to support aprosthetic device in patients who arepartially or completely endentulous. Thedevice can be used for single or multiple-unit restorations. The prosthesis can becemented or screw retained to theabutment. An abutment screw is used tosecure the abutment to the endosseousimplant.The CreoDent Solidex® CustomizedAbutment and Screw are compatible withthe following:Sweden & Martina Premium ImplantSystem 3.3mm and 3.8mm	The Premium abutments is intendedfor us with an endossous implant tosupport a prosthetic device in partiallyor completely edentulous patient. It isintended for use to support single andmultiple tooth prosthetic device in themandible or maxilla. The prostheticscan be cemented, screw retained orfriction fit to the abutment.
DimensionsandAngulations	Creodent Solidex Customized Abutment andScrew sizes forSweden & Martina Premium ImplantSystem 3.3mm and 3.8mmAngles not to exceed up to 20 degrees fromthe implant axis.	Sweden & Martina PremiumImplant System 3.3mm and 3.8mmStock abutments

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:

{7}------------------------------------------------

Compatible Device	Implant Diameters	Implant Lengths
Sweden & Martina PremiumImplant	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).

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.)