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

Straumann Tissue Level Standard Plus RN 3.3 and WN 6.5

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:

. Straumann Tissue Level Standard Plus RN 3.3 and WN 6.5
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 and maximum dimensions for wall thickness, diameter, height, collar height and angulation.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the "CreoDent Solidex® Customized Abutment and Screw." This document focuses on demonstrating substantial equivalence to already legally marketed devices, rather than presenting a de novo clinical study with specific acceptance criteria, comprehensive performance data from a test set, or details about training sets, expert adjudication, or MRMC studies typical for AI/ML device submissions.

Therefore, the requested information cannot be fully extracted from the provided text in the manner typically asked for AI/ML device descriptions. The document does not include:

A table of acceptance criteria and reported device performance in the context of an AI/ML algorithm.
Details about sample sizes for a test set, data provenance, ground truth establishment for a test or training set.
Information about expert numbers, qualifications, or adjudication methods for ground truth because the safety and effectiveness are established through physical performance testing and comparison to predicate devices, not through diagnostic performance in an AI/ML context.
Any mention of MRMC comparative effectiveness studies or standalone algorithm performance.

The study described is primarily a non-clinical, in-vitro performance study focusing on mechanical strength and material compatibility to demonstrate equivalence.

Here's what can be extracted and inferred based on the provided text, while acknowledging the limitations for an AI/ML context:

1. A table of acceptance criteria and the reported device performance:

The document doesn't present "acceptance criteria" and "reported device performance" in the way one would for diagnostic accuracy of an AI/ML device. Instead, it details technical specifications and performance characteristics that demonstrate the device's functional integrity and equivalence to predicate devices. The study's "acceptance" is implicitly that the device performs mechanically at least as well as, or comparably to, the predicate devices, particularly under "worst-case scenario" conditions.

Acceptance Criteria (Implicit by testing standard and comparison)	Reported Device Performance (Summary)
Mechanical Strength & Fatigue Resistance	Static/Fatigue Testing: Conducted in accordance with ISO 14801:2007E Dentistry-Implants-Dynamic fatigue test for endosseous dental implants, specifically targeting the "worst case scenario for the Solidex® Customized Abutment and Screw connection platform." Result: "These results demonstrated that the Solidex® Customized Abutment and Screw have sufficient mechanical strength for their intended clinical application." This implies that the device met the performance requirements or thresholds defined by the ISO standard for dental implants.
Dimensional Compatibility	Reverse Engineering Dimensional Analysis: Conducted using OEM implant bodies, OEM abutments, and OEM abutment screws. Result: Demonstrated the device's "compatibility with Straumann Tissue Level Standard Plus RN 3.3 and WN 6.5 for which they are intended." The document also notes that safeguards and limitations in the design software will be imposed according to specified design limitations built into the abutment designer (e.g., minimum/maximum dimensions for wall thickness, diameter, height, collar height, and angulation). The less extreme maximum angulation compared to a reference predicate was "mitigated by fatigue testing and reverse engineering dimensional analysis."
Sterilization Efficacy	Sterilization Testing: Conducted according to ISO 17665-1. Result: Sterilization was performed, implying that the protocol was effective and the device can be sterilized as intended.
Biocompatibility	Biocompatibility information is "leveraged from our previous 510k (K150012)," indicating that the material properties for biocompatibility are previously established and accepted for the predicate device, and the current device uses the same or an equivalent material (Ti-6Al-4V Eli titanium alloy).

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated as a number of "samples" for a "test set" in the context of an AI/ML study. For mechanical testing, the number of units tested per standard (ISO 14801:2007E) is typically small (e.g., 5-10 samples per test condition), but this specific number is not provided.
Data Provenance: The testing is described as "Non-clinical Testing Data," which typically means in-vitro lab testing. The materials for the abutment blanks and screws are sourced from specific suppliers (T.Strong INC in Korea, who obtains materials from US suppliers). The final manufacturing occurs at CreoDent's facility in New York. This is not "clinical data" provenance in terms of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth in this context is established by engineering specifications, material standards (ASTM, ISO), and performance under mechanical stress tests, not by expert human interpretation of medical images or clinical outcomes.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. There are no human adjudicators for the mechanical and material performance tests described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a dental implant component, not an AI/ML diagnostic imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. There is no AI algorithm involved. The device itself is a physical medical device. The "CAD/CAM Work Flow" is a manufacturing process using software to design the custom abutment, but this is not an AI/ML algorithm for making clinical decisions or performing diagnostics.

7. The type of ground truth used:

The "ground truth" for this device's performance validation is based on:

Engineering Standards: Adherence to ISO 14801:2007E for dynamic fatigue testing, ISO 17665-1 for sterilization, and ASTM F-136/F-67 for material (titanium alloy) specifications.
Predicate Device Performance: Demonstrating that the subject device's performance is equivalent to or better than that of the listed predicate devices (CreoDent Solidex Customized Abutments K150012, Straumann Tissue Level Standard Plus K171784) in terms of mechanical strength and compatibility for its intended use.
Design Specifications: Meeting internal design limitations (Min/Max dimensions for wall thickness, diameter, height, collar height, angulation).

8. The sample size for the training set:

Not applicable. No AI/ML training set is mentioned or relevant for this device.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K202095

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: November 11, 2020 Received: November 16, 2020

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Andrew Steen Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number K202095

Device Name: CreoDent Solidex® Customized Abutment and Screw

Indication for Use:

The CreoDent Solidex® Customized Abutment and Screw are compatible with the following:

Straumann Tissue Level Standard Plus RN 3.3 and WN 6.5 ●
Prescription Use X (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 K202095 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 December 3, 2020

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:

Common Name:

Product Code: Classification Panel: Reviewing Branch:

INDICATIONS FOR USE

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

The CreoDent Solidex® Customized Abutment and Screw are compatible with the following:

Straumann Tissue Level Standard Plus RN 3.3 and WN 6.5 ●

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DEVICE DESCRIPTION

. Straumann Tissue Level Standard Plus RN 3.3 and WN 6.5
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 and maximum dimensions for wall thickness, diameter, height, collar height and angulation.

Straumann Tissue LevelStandard Plus	RN 3.3mm		WN 6.5mm
Max Diameter	5mm from Implant Axis		5mm from Implant Axis
Min Wall thickness	.68mm		.68mm
	Max	Min	Max	Min
Height	10mm	5mm	10mm	5mm
Collar Height	5mm	1mm	5mm	1mm
Post Height	9mm	4mm	9mm	4mm
Degree of Angulation	20	0	20	0

CAD/CAM Work Flow

The Solidex® Customized Abutment and Screw is CAD/CAM Patient Specific machine manufactured per prescription received from a dentist. The dentist will specify the implant type and size. Upon receiving the prescription from the dentist. CreoDent will only manufacture Solidex® Customized Abutment and Screw for which they have received FDA 510K clearance. Safe guards and limitation in the design software will be imposed according to specified design limitations built into abutment designer. Abutment blanks for each implant platform are produced to CreoDent Prosthetics, Ltd. specifications in Ti-6A1-4V Eli titanium alloy and Screw is CP TI Gr4 supplied by T.Strong INC, a Korean company located at 403, 433-8, Jangan-dong, Dongdeamun-gu, Seoul 130-100, Republic of Korea. T.Strong.INC obtains the abutment blank and screw materials from suppliers in the USA. All abutment blanks have prefabricated interfaces. CreoDent custom mills the non-interface portion of the abutment.

T.Strong INC obtains titanium alloy and c.p. titanium from US suppliers and mills the abutment-to-implant connection platform according to the design specifications provided by CreoDent Prosthetics, Ltd. CreoDent Prosthetics finalizes the abutment device, according to a prescription provided by a dentist at the registered and listed CreoDent manufacturing facility in New York.

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EQUIVALENCE TO MARKETED DEVICE

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

CreoDent Solidex Customized Abutments (K150012) Primary Predicate
. Straumann Tissue Level Standard Plus RN 3.3 and WN 6.5 (K171784)

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-6Al-4V Eli titanium alloymeets ASTM F-136 Standard. It is a highergrade material with more tensile strength.The Screw is CP TI Gr4 meets ASTM F67Standard.
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 cemented orscrew retained to the abutment. Theabutment screw is designed to secure theabutment to the endosseous implant.
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 the abutment.An abutment screw is used to secure theabutment to the endosseous implant.The CreoDent Solidex® CustomizedAbutment and Screw are compatible withthe following:	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 abutmentscrew is used to secure the abutment to theendosseous implant.The CreoDent Solidex® CustomizedAbutment is compatible with the following:
	Straumann Tissue Level StandardPlus RN 3.3 and WN 6.5	Biomet 3i Osseotite Certain DentalImplants 3.25mm, 4mm, 5mm,6mm

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

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		Straumann Bone Level implants 3.3mm, 4.1mm, 4.8mm
Dimensions and Angulations	CreoDent Solidex Customized Abutment and Screw sizes for Straumann Tissue Level Standard Plus RN 3.3 and WN 6.5 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.Straumann Bone Level implants 3.3mm, 4.1mm, 4.8mmAngles not to exceed up to 20 degrees from the implant axis.

Substantial Equivalence discussion difference: The differences between the subject device and the Primary predicate is the compatible implant bodies. This comparison is for similarity of device not for implant compatibility.

TechnologicalCharacteristics	CreoDent Solidex® CustomizedAbutment and Abutment Screw	Reference Predicate Device forclaimed equivalence: StraumannTissue Level Standard Plus RN 3.3and WN 6.5 (K171784)
Material	Abutment and Screw are Ti-6A1-4V Elititanium alloy meets ASTM F-136Standard.	Abutment and Screw are Ti-6Al-7Nbtitanium alloy(TAN)
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 cemented orscrew retained to the abutment. Theabutment screw is designed to secure theabutment to the endosseous implant.
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 the abutment.An abutment screw is used to secure theabutment to the endosseous implant.	Abutments are placed into the dentalimplants to provide support for prostheticrestoration such as crowns, bridges andoverdentures.Titanium Abutment is indicated forcemented restoration. The abutment can beused in single tooth replacements andmultiple tooth restorations
	The CreoDent Solidex® CustomizedAbutment and Screw are compatible withthe following:Straumann Tissue Level StandardPlus RN 3.3 and WN 6.5

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

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DimensionsandAngulations	CreoDent Solidex Customized Abutmentand Screw sizes forStraumann Tissue Level Standard Plus RN 3.3 and WN 6.5 Angles not to exceed up to 20 degrees from the implant axis.	Straumann Abutment sizes for Straumann Tissue Level Implants RN 3.3mm and WN 6.5mmAngles not to exceed up to 30 degrees from the implant axis.
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Substantial Equivalence discussion differences: The only difference between the subject device and the reference predicate is the maximum angulation. Solidex Customized abutments have a less extreme maximum angulation. The difference is also mitigated by fatigue testing and reverse engineering dimensional analysis.

Compatible Device	Implant Diameters	Implant Lengths
Straumann Tissue LevelStandard Plus	RN 3.3mm	6 mm8 mm10 mm12 mm14 mm
	WN 6.5mm	6 mm8 mm10 mm12 mm

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

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 Straumann Tissue Level Standard Plus RN 3.3 and WN 6.5 for which they are intended. Biocompatibility information is leveraged from our previous 510k (K150012).

CONCLUSION:

Solidex Customized Abutments incorporates the same material, similar indications for use, dimension, design, abutment seat, screw seat, anatomical site, connection, type of retention 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 3rd 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.)