The UF(II) Bar holder abutment is intended to be used as a retention device in conjunction with the fixture in the maxillary and/or mandibular arch to provide support for overdentures for partially and fully edentulous patients.

Device Description

UF(II) Bar holder abutment and set screw is used for prosthetic restoration. Bar holder abutment is intended to be used in conjunction with the fixture in the maxillary and/or mandibular arch to provide support for overdentures for partially and fully edentulous patients. UF(II) Bar holder abutments are made from Ti-6Al-4V ELI (ASTM F136). The UF(II) Bar holder abutment has two type shape which are Single body type and Cap type.

The UF(II) Bar holder abutment of single body type consists of abutment screw and set screw. The UF(II) Bar holder abutment of cap type consists of abutment screw, set screw and abutment cap. Both type Bar holder abutment has Hex, Non-Hex connection. Subject abutments are only intended for multi-unit restorations. It is provided non-sterile, this should be user steam sterilized before use. It is used for overdentures with clip for bar retention. The clip is fixed to the overdenture and used to supplement the retention of the bar and denture. The bar is used to fix the abutment and overdenture. It is held in place with the set screw. The cap is used to cover the bar holder abutment Cap Type. The components-clip, bar, and cap--are included in the device system.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the UF(II) Bar holder abutment:

This document is a 510(k) summary for a medical device (UF(II) Bar holder abutment). It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through clinical or standalone studies for a new type of AI/diagnostic device.

Therefore, the requested information elements related to AI algorithm performance (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable in this context. This is a traditional medical device submission for an implant component, where the focus is on mechanical integrity, materials, and intended use comparison to existing devices.

However, I can extract the relevant information regarding the non-clinical testing performed to establish substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are derived from established international standards for dental implants and abutments. Since no specific performance metrics like sensitivity/specificity are reported for this type of device, the "reported device performance" is successful completion of the specified tests, thereby demonstrating substantial equivalence.

Acceptance Criteria (Standard & Purpose)	Reported Device Performance
Fatigue Test: ISO 14801:2007 Dentistry-Implants-Dynamic fatigue test for Endosseous Dental Implants	The results of the non-clinical testing demonstrate that the results have met the criteria of the standards, and the subject device is substantially equivalent to the predicate/reference devices. (Performed on worst-case scenario: smallest diameter with maximum angulation).
Sterilization Validation: ISO 17665-2 for steam sterilization (leveraged from K181037)	A Sterilization Assurance Level (SAL) of 10⁻⁶ was achieved, and all testing requirements were met. The device is provided non-sterile for user sterilization.
Biocompatibility: FDA Guidance Document Use of International Standard ISO 10993-1 (leveraged from K161987)	Ti-6Al-4V ELI (ASTM F136) material used is the same as in K161987, and no new biocompatibility issues are raised. No additional biocompatibility testing was required.

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

Sample Size for Fatigue Test: Not explicitly stated as a number of devices, but the test was performed on "finished assembled implant/abutment systems of the worst-case scenario (smallest diameter with maximum angulation)." This implies a representative number of units for the specific configurations tested, as per the ISO standard.
Data Provenance: The standard (ISO 14801:2007) is international. The testing itself would have been conducted by the manufacturer or a contracted lab. The document does not specify country of origin for the test results, but the submitter (DIO Corporation) is from the Republic of Korea. It is a prospective test, newly performed or leveraged for this submission.

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

Not Applicable. This is a mechanical/material performance test, not a diagnostic or AI-driven assessment requiring expert ground truth for interpretation. The "ground truth" is determined by the physical outcome of the tests (e.g., whether the device fractured at a certain load, whether the sterilization parameters were met).

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

Not Applicable. See point 3.

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 device is a physical dental implant abutment, not an AI diagnostic tool.

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

Not Applicable. See point 5.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the fatigue test: The "ground truth" is the physical failure or non-failure of the device under specific, controlled dynamic loading conditions, as defined by the ISO standard.
For sterilization: The "ground truth" is the measurable Sterilization Assurance Level (SAL), typically confirmed by biological indicators or other validated methods.
For biocompatibility: The "ground truth" is the established safety profile of the material based on chemical composition and previous testing (ISO 10993).

8. The sample size for the training set

Not Applicable. There is no training set as this is not an AI/machine learning device.

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

Not Applicable. There is no training set.

Summary

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May 18, 2020

DIO Corporation % Joyce Kwon CEO Provision Consulting Group Inc. 100 N. Barranca Street, Suite 700 West Covina, California 91791

Re: K193404

Trade/Device Name: UF(II) Bar holder abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: February 6, 2020 Received: February 18, 2020

Dear Joyce Kwon:

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.

for

Srinivas Nandkumar, Ph.D. 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 (if known) K193404

Device Name UF(II) Bar holder abutment

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

× Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo consists of the letters "DIO" in a stylized font, with "DI" in gray and "O" in pink with a pink dot above it. Below the letters, the words "Implant Solution" are written in a smaller, gray font.

K193404 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirement of 21 CFR part 807.92

Submitter:

JiAe, Park DIO Corporation 66 Centum seo-ro, Haeundae-gu, Busan, 48058, Republic of Korea Phone +82-51-745-7836 Fax +82-51-745-7781

Official correspondent:

Joyce Kwon Provision Consulting Group 100 N. Barranca St. Suite 700, West Covina, CA 91791 Email: Info@provisionfda.com Phone: 1-909-493-3276

Device Information:

Trade Name: UF(II) Bar holder abutment Common Name: Endosseous dental implant abutment Classification Name: Abutment, Implant, Dental, Endosseous Product Code: NHA Panel: Dental Regulation Number: 21 CFR 872.3630 Device Class: Class II Date prepared: 05/18/2020

General Description

Indication For Use

Predicate devices

The subject device is substantially equivalent to the following Predicate Device: Primary Predicate Device: ERA® Micro 23° and 30° Female Abutment (K130408)

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Image /page/4/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo consists of the letters "DIO" in a bold, sans-serif font. The "DIO" letters are in gray, except for the dot over the "i", which is pink. Below the letters, the words "Implant Solution" are written in a smaller, sans-serif font, also in gray.

Reference Device: UF(II) Narrow Implant System (K161987) DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM, Ball abutment (K122519) DIO CAD/CAM Abutment (K181037)

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Image /page/5/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo has the text "DIO" in gray, with the "O" in pink and a pink dot above it. Below the text "DIO" is the text "Implant Solution" in gray. The logo is simple and modern.

Summaries of Technological Characteristics

The subject device is substantially equivalent of the are substantially equivalent in intended use, material and connection interfaces to the implants are identical for each individual diameter and connection demonstrating Substantial Equivalence follows:

	Subject Device	Primary Predicate Device	Reference Device
Applicant	DIO Corporation	Sterngold Dental, LLC	DIO Corporation	DIO Corporation	DIO Corporation
Trade Name	Bar holder abutment	ERA® Micro 23° and 30°Female Abutment	DIO UF HSA INTERNALSUB-MERGEDIMPLANT SYSTEM, Ballabutment	UF(II) Narrow ImplantSystem	DIO CAD/CAM Abutment
510(K) No.	Not yet assigned	K130408	K122519	K161987	K181037
ClassificationName	Endosseous Dental ImplantAbutments (872.3630)	Endosseous Dental ImplantAbutments (872.3630)	Endosseous Dental ImplantAbutments (872.3630)	Endosseous Dental ImplantAbutments (872.3630)	Endosseous Dental ImplantAbutments (872.3630)
Product Code	NHA	NHA	NHA	NHA	NHA
Class	II	II	II	II	II
Material	Ti-6Al-4V ELI(ASTM F136)	Ti-6Al-4V ELI(ASTM F136)	Ti CP-4 (ASTM F67)	Ti-6Al-4V ELI(ASTM F136)	Ti-6Al-4V ELI(ASTM F136)
Surfacetreatment	Machined	TiN Coated	Machined	Machined	Machined
Design	Image: Bar holder abutment	Image: ERA® Micro 23° and 30° Female Abutment	Image: DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM, Ball abutment	Image: UF(II) Narrow Implant System	N/A
Diameters(mm)	4.5	not defined	3.5	3.5	3.0/3.3/3.8/4.0/4.5/5.0/5.5/6.0/6.5/7.0
Height (mm)	6.5/7.0/8.0/9.0/	not defined	4.5/5.5/6.5/7.5/8.5/9.5	4.5/5.5/6.5/7.5/8.5/9.5/10.5	3.1~14.9
Angulation	0°	23°, 30°	0°	0°	0°~15°
Sterilization	Steam Sterilization by user(Delivered non-sterile)	Steam Sterilization by user(Delivered non-sterile)	Steam Sterilization by user(Delivered non-sterile)	Steam Sterilization by user(Delivered non-sterile)	Steam Sterilization by user(Delivered non-sterile)
IndicationsFor Use/Intended Use	The UF(II) Bar holderabutment is intended to beused as a retention devicein conjunction with thefixture in the maxillaryand/or mandibular arch toprovide support foroverdentures for partiallyand fully edentulouspatients.	The ERA® Micro 230 and300 Females are intendedto be used as a retentiondevice in conjunction withthe Sterngold Acid EtchDental Implant System inthe maxillary and/ormandibular arch to providesupport for overdenturesfor partially and fullyedentulous patients.	Ball Abutment can be usedto prepare fully or partiallyover denture. BallAbutment system consistsof ball abutment, retainer,ball abutment cap, and ballanalog.	Ball Abutment is intendedfor use in conjunction withthe fixture in partially orfully endentulousmandibles and maxillae andused for producing denture.	DIO CAD/CAM Abutmentis intended for use withdental implants as a supportfor single or multiple toothprostheses in the maxilla ormandible of a partially orfully edentulous patient.
	Similarities:
	UF(II) Bar holder abutment is substantially equivalent in indications for use as Primary Predicate device (K130408), while material, sterilization,angulation, packaging, manufacturing process and technological characteristics are same as its reference devices K122519, and K161987.

SubstantialEquivalenceDiscussion	Differences:The subject device and reference devices are different in shape and dimension. To support this discrepancy, we performed the fatigue test.The subject device's length is different from reference device (K161987). However, the subject device length is in the range of length of referencedevice (K161987). The subject device has a difference in the technological characteristic that the device is designed to maintain a denture bar forclipping a removable denture. The identified reference predicates are ball attachment types.

	The UF(II) Bar holder Abutment is identical in fundamental scientific technology to the predicate and reference devices in that they all havebeen designed, manufactured and tested in compliance with FDA's Class II special controls guidance document root-food endosseous dentalimplants and endosseous dental implant abutments.
	Any differences in technology characteristics are accompanied by information that demonstrated the device is substantially equivalent as thepredicate device and do not raise different questions of safety and effectiveness than the predicate.

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DIO Corporation Traditional 510(k) Submission UF(II) Bar holder abutment(K193404)

Image /page/6/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo consists of the letters "DIO" with "DI" in gray and "O" in pink. Below the letters, the words "Implant Solution" are written in gray.

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Image /page/7/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo consists of the letters "DIO" in a bold, sans-serif font. The "DI" is in gray, while the "O" is in pink with a small pink circle above it. Below the letters, the words "Implant Solution" are written in a smaller, gray font.

Non-clinical Testing

Non-clinical testing was conducted in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments", and it consisted of testing finished assembled implant/abutment systems of the worst-case scenario, (smallest diameter with maximum angulation) through fatigue testing. The results of the non-clinical testing demonstrate that the results have met the criteria of the standards, and the subject device is substantially equivalent to the predicate/reference devices.

Fatigue Test

The fatigue test was performed on the subject device in accordance with ISO 14801:2007 Dentistry-Implants-Dynamic fatigue test for Endosseous Dental Implants. The worst-case scenario was chosen based on the FDA guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".

The subject device was tested to evaluate its substantial equivalence according to the following standards. - Fatigue Test according to ISO 14801:2007

Fatigue Test according to ISO 11601:2007

Sterilization Validation and Shelf Life Testing

User Sterilization Validation Report performed in K181037 was leveraged for the subject device. Sterilization validating testing in K181037 has been performed in accordance with ISO 17665-2 for steam sterilization. Test results have demonstrated that the SAL of 10- was achieved and all testing requirements were met. The subject devices are provided non-sterile status.

Biocompatibility

The Biocompatibility Test are leveraged from own reference device (K161987).

We provided the biocompatibility test report of the Ti-6Al-4V ELI (ASTM F136) in own reference device (K161987) per the FDA Guidance Document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process". Ti-6AI-4V ELI (ASTM F136) used for the subject device and own reference device (K161987) is exactly same from same manufacturer. The reference device (K161987) support substantial equivalences because same manufacturing process and material are used for subject and own predicate device. No new issues of biocompatibility are raised for the subject devices. Therefore, no additional biocompatibility testing was required.

Summary of clinical testing

No clinical testing was performed for this submission.

Conclusions

The UF(II) Bar holder abutment constitutes a substantially equivalent medical device. This system has the same intended use and fundamental scientific technology as its predicate and reference devices. Therefore, UF(II) Bar holder abutment sand its predicates are substantially equivalent.

<DIO-QP-402-07_Rev.02>

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.)