The UF(II) Anatomic abutment is intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The abutment can be used in single tooth replacements and multiple tooth restorations.

Device Description

The UF(II) Anatomic abutment is intended to be used with the root-form endosseous dental implant to aid in prosthetic rehabilitation. The anatomic abutment has scalloped margins to follow the gingival contour to provide better esthetic results with the final prosthesis. It consist of straight abutment and angled of 5°, 18°, and are made from titanium alloy conforming to ASTM F136. The anatomic abutments are pre-manufactured (stock) abutments is provided non-sterile, this should be user steam sterilized before use.

AI/ML Overview

The provided text describes the 510(k) summary for the UF(II) Anatomic abutment, focusing on establishing substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a study design for device performance. Medical devices like this, classified as Class II, typically undergo performance testing to ensure safety and effectiveness.

Based on the information provided, here's a breakdown of the acceptance criteria and the studies conducted:

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

The document mentions several tests performed according to specific ISO standards and FDA guidance. The "acceptance criteria" are implied by adherence to these standards and demonstration of "substantial equivalence." The "reported device performance" is framed as successful completion of these tests, indicating the device meets the requirements of the standards.

Acceptance Criteria (Implied)	Reported Device Performance (as described in document)
Sterilization Validation: Achieve a Sterility Assurance Level (SAL) of 10^-6 for steam sterilization, per ISO 17665-1 and ISO 17665-2, and FDA Guidance.	"Test results have demonstrated that the SAL of 10-6 was achieved and all testing requirements were met. Sterilization was conducted in accordance with FDA Guidance 'Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling'."
Fatigue Test: Meet the dynamic fatigue resistance requirements for endosseous dental implants, considering worst-case scenarios, as per ISO 14801:2007 and FDA Guidance.	"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... The subject device was tested to evaluate its substantial equivalence..."
Biocompatibility: Demonstrate biocompatibility based on material composition and contact with the body, following ISO 10993-1 and FDA Guidance.	"The Biocompatibility Test are leveraged from previous submission (K122519). Biocompatibility test conducted in accordance with 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'." "No new issues of biocompatibility are raised for the subject devices. Therefore, no additional biocompatibility testing was required."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes used for the non-clinical tests (sterilization, fatigue). It refers to standard testing protocols outlined in the cited ISO standards and FDA guidance documents. These standards typically specify the number of samples required for robust testing.

Sterilization Validation: Sample size not specified, but implied to be sufficient for achieving SAL of 10^-6 according to ISO 17665-1 and ISO 17665-2.
Fatigue Test: Sample size not specified, but implied to be sufficient for testing according to ISO 14801:2007, often involving multiple samples tested to failure or a specified number of cycles. The test was conducted on "the subject device."
Biocompatibility: No new samples were tested for biocompatibility; it was leveraged from a previous submission (K122519).

Data Provenance: The document does not specify the country of origin of the data for the non-clinical tests, nor whether the studies were retrospective or prospective. These are lab-based tests, not clinical studies involving human patients. The submitter is DIO Corporation, located in the Republic of Korea, so the testing was likely conducted in that region or by a contract lab.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable in the context of this 510(k) submission. The "ground truth" for non-clinical performance tests like sterilization and fatigue are objective measurements against established engineering and biological standards (e.g., microbial kill rate, force sustained before failure). These tests do not typically involve human expert interpretation or consensus for establishing "ground truth" in the way a clinical diagnostic accuracy study would.

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

This question is not applicable. Adjudication methods are used in clinical studies where human interpretation or a "gold standard" reference is subject to variability or requires reconciliation among multiple experts. The non-clinical tests described are objective, laboratory-based physical and biological assessments.

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

This question is not applicable. The device described, the UF(II) Anatomic abutment, is a dental implant component (an abutment). It is a passive mechanical device and not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study or AI assistance is not relevant to its evaluation.

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

This question is not applicable, as the device is mechanical and not an algorithm or AI system.

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

As discussed in point 3, the concept of "ground truth" derived from expert consensus, pathology, or outcomes data is not directly applicable to the non-clinical performance tests mentioned in the document.

For:

Sterilization Validation: The "ground truth" is an objective measurement of microbial reduction (e.g., spore log reduction) or sterility against a defined standard.
Fatigue Test: The "ground truth" is the objective mechanical performance (e.g., cycles to failure, maximum load sustained) measured by engineering equipment against the requirements of ISO 14801.
Biocompatibility: The "ground truth" is derived from established biological responses to materials as per ISO 10993-1 (e.g., cytotoxicity, sensitization, irritation).

8. The sample size for the training set

This question is not applicable, as this is a mechanical device, not a machine learning model requiring a training set.

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

This question is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym and name on the right. The FDA acronym is in a blue square, and the full name "U.S. Food & Drug Administration" is in blue text.

September 30, 2019

DIO Corporation % Peter Kang Business Manager DIO USA 3470 Wilshire Blvd, #620 Los Angeles, California 90010

Re: K190048

Trade/Device Name: UF(II) Anatomic abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: August 28, 2019 Received: August 30, 2019

Dear Peter Kang:

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.

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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.

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. Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190048

Device Name UF(II) Anatomic abutment

Indications for Use (Describe)

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

X 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 has the letters "DIO" in a sans-serif font, with "DI" in gray and "O" in pink with a small pink circle above and to the right of it. Below the letters is the text "Implant Solution" in a smaller, gray, sans-serif font.

510(k) Summary

K190048

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

Submitter:

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

Contact / US agent:

DIO USA. Peter, Kang 3470 Wilshire Blvd. #620 Los Angeles, CA Phone +1-213-365-2875 Fax +1-213-365-1595

Device Information:

Trade Name: UF(II) Anatomic 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: 09/26/2019

General Description

Indication For Use

Predicate devices

The subject device is substantially equivalent to the following predicate and Reference Device: Primary Predicate Device : P.004 RC Anatomic Abutments (K062129) Reference Device : P.004 NC Anatomic abutment (K071357) Neodent Implant System CM Anatomic Abutment (K150199)

DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM (K122519)

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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 "D" and "I" are in gray, while the "O" is in pink with a small pink circle above and to the right of it. Below the letters, in a smaller font, are the words "Implant Solution".

Summaries of Technological Characteristics

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

	Subject Device	PrimaryPredicate Device	Reference Device
Applicant	DIO Corporation	Institut Straumann AG	Straumann US (on behalf ofInstitut Straumann AG)	JJGC Industria E ComercioDe Materiais Dentarios SA	DIO Corporation
Trade Name	UF(II) Anatomicabutment	P.004 RC AnatomicAbutments	P.004 NC AnatomicAbutment	Neodent Implant System	DIO UF HSA INTERNALSUB-MERGED IMPLANTSYSTEM
510(K) No.	K190048	K062129	K071357	K150199	K122519
ClassificationName	Endosseous DentalImplant, Abutment(872.3630)	Endosseous DentalImplant, Abutment(872.3630)	Endosseous Dental Implant,Abutment(872.3630)	Endosseous Dental Implant,Abutment(872.3630)	Endosseous Dental Implant,Abutment(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-6Al-4V ELI(ASTM F136)	Ti-6Al-4V ELI(ASTM F136)
Design	Image: UF(II) Anatomic abutment	Image: P.004 RC Anatomic Abutments	Image: P.004 NC Anatomic Abutment	Image: Neodent Implant System	Image: DIO UF HSA INTERNAL SUB-MERGED IMPLANT SYSTEM
AbutmentDiameters (mm)	4.21/4.49/4.84/5.11/6.14	6.5	4.0	4.7/6.0	4.5/5.5

Gingival heights	1.5/2.5/3.5/4.5/5.5	2.0/3.5	2.0/3.5	1.5/2.5/3.5	1.5/2.0/3.0/4.0/5.0
Angle	5/18	0/15	0/15	0/17	15/25
Sterile	Steam Sterilization byuser(Delivered non sterile)	Steam Sterilization byuser(Delivered non sterile)	Steam Sterilization by user(Delivered non sterile)	Steam Sterilization by user(Delivered non sterile)	Steam Sterilization by user(Delivered non sterile)
Type ofRetention	Screw-retained or cementretained	Screw-retained or cementretained	Screw-retained or cementretained	Screw-retained or cementretained	Screw-retained or cementretained
Intended Use	The UF(II) Anatomicabutment is intended to beplaced into dentalimplants to providesupport for prostheticreconstructions such ascrowns or bridges. Theabutment can be used insingle tooth replacementsand multiple toothrestorations.	The P.004 Implants areintended for immediate,delayed or conventionalplacement in the maxillaand/or mandibular archesto support crowns, bridgesor overdentures inedentulous or partiallyedentulous patients.They are intended forimmediate function onsingle-tooth and/ormultiple toothapplications when goodprimary stability isachieved and withappropriate occlusalloading, to restorechewing function.Multiple toothapplications may berigidly splinted. In thecase of edentulous	Abutments are intended to beplaced into dental implantsto provide support forprosthetic reconstructionssuch as crowns, bridges andoverdentures. Abutments canbe used in single toothreplacements and multipletooth restorations.	CM Alvim Acqua ImplantThe Neodent Implant Systemis intended to be surgicallyplaced in the bone of theupper or lower jaw toprovide support forprosthetic devices such asartificial teeth, to restorechewing function. It may beused with single-stage ortwo-stage procedures, forsingle or multiple unitrestorations, and may beloaded immediately whengood primary stability isachieved and withappropriate occlusal loading.Multiple tooth applicationsmay be rigidly splinted.Facility Acqua ImplantThe Neodent Implant Systemis intended to be surgicallyplaced in the bone of the	The DIO UF HSA InternalSub-Merged Implant Systemis indicated for surgicalplacement in the upper andlower jaw arches, to providea root form means for singleor multiple unit's prostheticattachment to restore apatient's chewing function.The smaller(Ø3.8~5.5)implants can be placed witha conventional two stagesurgical process with anoption for transmucosalhealing or they can be placedin a single stage surgicalprocess with an option fortransmucosal healing or theycan be placed in a singlestage surgical process forimmediate loading whengood primary stability isachieved with appropriateocclusal loading. The

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Image /page/5/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo has the letters DIO in a sans-serif font, with the DI in gray and the O in pink. There is a small pink circle above the O. Below the letters is the text "Implant Solution" in a smaller, gray font.

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Image /page/6/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 and to the right of it. Below the letters, the words "Implant Solution" are written in a smaller, gray font.

	implants must be used.Abutments are intendedto be placed into dentalimplants to providesupport for prostheticreconstructions such ascrowns or bridges. Mesoabutments are indicatedfor cemented restorationsparticularly in estheticareas of the mouth. Theabutment can be used insingle tooth replacementsand multiple toothrestorations.	upper or lower jaw toprovide support forprosthetic devices such asartificial teeth, to restorechewing function. It may beused with single-stage ortwo-stage procedures, forsingle or multiple unitrestorations, and may beloaded immediately whengood primary stability isachieved and withappropriate occlusal loading.The Facility implant isindicated for replacement ofmaxillary lateral incisors,mandibular incisors orretention of overdentures.	larger(Ø6.0~7.0) implantscan be placed with aconventional two stagesurgical process with anoption for transmucosalhealing and are indicated forthe molar region withdelayed loading.
		CM Anatomic Abutment,Exact Anatomic, LateralAnatomic, and LateralAnatomic AbutmentsThe Neodent Implant Systemis intended to be surgicallyplaced in the bone of theupper or lower jaw toprovide support forprosthetic devices such asartificial teeth, to restorechewing function. It may beused with single-stage ortwo-stage procedures, for

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Image /page/7/Picture/1 description: The image shows the logo for DIO Implant Solution. The letters "DIO" are in a bold, sans-serif font, with the "O" in pink and the rest in gray. Above the "O" is a small pink circle. Below the logo is the text "Implant Solution" in a smaller, gray, sans-serif font.

				single or multiple unitrestorations, and may beloaded immediately whengood primary stability isachieved and withappropriate occlusal loading.
SubstantialEquivalenceComparison	The UF(II) Anatomic abutment is substantially equivalent in designs, dimensions, material, indications, and technological characteristics with theidentified primary predicate device. The UF(II) Anatomic abutment is similar in fundamental scientific technology to the predicate device in thatthey all have been designed, manufactured and tested in compliance with FDA's Class II special controls guidance document root-foodendosseous dental implants and endosseous dental implant abutments.The diameters and angulation of the subject device are slightly different from the predicate devices. However, the subject diameters and angulations arein the range of diameters and angulation of predicates.The Indications for Use of the subject and primary predicate device are identical other than lack of the first sentence and middle sentence for fixture. Itis acceptable since the subject device is anatomic abutment only. Therefore, the indication related to fixture was excluded. Thus, the proposedindications do not increase risk nor change the intended use of the device and are found to be substantially equivalent.Any differences in technology characteristics are accompanied by information that demonstrated the device is substantially equivalent as thepredicate and do not raise different questions of safety and effectiveness than the predicate.

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Image /page/8/Picture/1 description: The image shows the logo for DIO Implant Solution. The logo consists of the letters "DIO" in a stylized font. The "DI" is in gray, while the "O" is in pink with a small pink circle above and to the right of it. Below the letters, in a smaller gray font, are the words "Implant Solution."

Non-clinical Testing

The results of the non-clinical testing demonstrate that the results have met the standards, and the subject device is substantially equivalent to the predicate device. This testing included:

Sterilization Validation

Sterilization validating testing has been performed in accordance with ISO 17665-1 and ISO 17665-2 for steam sterilization. Test results have demonstrated that the SAL of 10-6 was achieved and all testing requirements were met. Sterilization was conducted in accordance with FDA Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling".

For the subject devices provided non-sterile status.

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

Biocompatibility

The Biocompatibility Test are leveraged from previous submission (K122519). Biocompatibility test conducted in accordance with 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". Abutments have the identical nature of body contact, contact duration, material formulation, manufacturing processes, and sterilization methods compared to the primary and reference devices. No new issues of biocompatibility are raised for the subject devices. 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".

Therefore, no additional biocompatibility testing was required.

Conclusions

The UF(II) Anatomic abutment 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, UF(II) Anatomic abutment send its predicates are substantially equivalent.

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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.)