Premilled Titanium Block System is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

Device Description

Patient-specific abutment is made from titanium alloy conforming to ASTM F136 titanium abutment to be used in fabricating patient-specific abutments. The subject abutments are indicated for cemented or "Screw-and Cement-Retained Prosthesis(SCRP)" restorations. Each patient-specific abutment is individually prescribed by the clinician.

The subject Premilled Titanium Block System has two types of blocks, Premilled Titanium Block (Hex, Non-Hex) and Magic Premilled Titanium Block (Hex, Non-hex) based on the compatible implant system.

AI/ML Overview

This document describes a 510(k) premarket notification for the "Premilled Titanium Block System" by InnoBioSurg Co., Ltd. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission focuses on comparing the new device to an existing one, rather than conducting a de novo study to establish new performance criteria. Therefore, the information provided below is extracted based on the principles of substantial equivalence as demonstrated by the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify general "acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, or accuracy for the device itself, as this is a dental abutment system and not an AI/diagnostic device. Instead, the "acceptance criteria" can be inferred from the non-clinical testing performed to establish substantial equivalence with the predicate device. The performance is assessed against established standards for dental implants and abutments.

Acceptance Criterion (Inferred from testing standards)	Reported Device Performance
Fatigue Resistance: Compliance with ISO 14801:2016 for dental implants (Worst-case scenario: smallest diameter with maximum angulation)	Met the criteria of the standard (Demonstrated in non-clinical testing)
Biocompatibility: Compliance with ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-6:2007, and ISO 10993-10:2010	Met the criteria of the standard (Leveraged from predicate devices)
End User Sterilization Validation: Compliance with ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1	Met the criteria of the standard (Leveraged from predicate devices)
Substantial Equivalence: Similar designs, dimensions, material, indications, abutment seat, screw seat, anatomical site, connection, and technological characteristics to the predicate device	Demonstrated (Based on comparison and non-clinical test results)

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

For the fatigue tests performed on the subject device:

Sample Size: The document indicates that fatigue tests were conducted "under the worst-case scenario." While a specific number isn't given, standard ISO 14801 testing protocols usually involve a predefined number of samples (often 10 for each test condition) to establish fatigue limits. It specifies only the "worst-case scenario" (smallest diameter with maximum angulation) was tested for the new device.
Data Provenance: Not explicitly stated (e.g., country of origin). It is a non-clinical, mechanical test, not patient data. The study type is a laboratory-based equivalency testing study, not retrospective or prospective clinical data.

For biocompatibility and sterilization validation tests:

These tests were leveraged from predicate devices (K152520, K173120, K192197). This means new tests with a specific sample size for the subject device were not performed for these aspects. The sample sizes and provenance for these predicate studies are not detailed in this document.

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

N/A. This document describes a submission for a mechanical dental device (abutment system) based on substantial equivalence and non-clinical testing, not an AI/diagnostic device that requires expert-established ground truth for a test set. There were no human readers or expert panels involved in determining the "ground truth" for the non-clinical tests described.

4. Adjudication Method for the Test Set

N/A. As this is not an AI/diagnostic device, no adjudication method (e.g., 2+1, 3+1) was used for a test set in the context of clinical or diagnostic performance. The evaluation was based on adherence to ISO standards for mechanical and material properties.

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

No. An MRMC study is not applicable to this type of device. This is a physical dental abutment system, and its performance is evaluated through engineering and materials testing, not through reader perception or diagnostic accuracy.

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

No. This is not an AI algorithm or a software-only device. The evaluation focuses on the physical properties and performance of the dental abutment system itself.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests (fatigue, biocompatibility, sterilization) is defined by the successful adherence to the specified international standards (ISO, ANSI/AAMI). For example, for fatigue, the "ground truth" is that the device withstands a certain number of load cycles at a specified force without failure, as per ISO 14801. For biocompatibility, it's the absence of adverse biological reactions as defined by ISO 10993 standards.

8. The Sample Size for the Training Set

N/A. This submission is for a physical medical device (dental abutment system) and does not involve AI or machine learning algorithms that require a "training set."

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

N/A. Not applicable, as there is no training set for this type of device submission.

Summary

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InnoBioSurg Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620

Re: K203344

Trade/Device Name: Premilled Titanium Block System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: July 20, 2021 Received: July 26, 2021

Dear April Lee:

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 (QS) 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 I. Steen Assistant Director DHT1B: Division of Dental and ENT 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) K203344

Device Name Premilled Titanium Block System

Indications for Use (Describe)

Premilled Titanium Block System is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

Implant System Compatibility	Implant Diameter (mm)	Platform Diameter (mm)
IBS Implant System	3.8/4.3/4.8/5.3/5.8/6.3	3.8/4.3/4.8/5.3/5.8/6.3
IBS Implant System	3.5/4.0/4.5/5.0/5.5/6.0/6.5	3.5/4.0/4.5/5.0/5.5/6.0/6.5
Magicore System	4.0/4.5/5.0/5.5/6.0/6.5	4.0/4.5/5.0/5.5/6.0/6.5
IBS Implant System II	3.5/3.8/4.0/4.5/5.0/5.5/6.0/6.5	3.5/3.8/4.0/4.5/5.0/5.5/6.0/6.5

Premilled Ttanium Block System is intended for use with the IBS implant system and IBS Implant System II in the chart. All digitally designed abutments for use with Premilled Titanium Block System are intended to be manufactured at a Innobiosurg validated milling center.

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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510(k) Summary

Submitter

InnoBioSurg Co., Ltd. Sun-Mi Park 44-19, Techno 10-ro, Yuseong-gu Daejeon, 34027 Republic of Korea Email: smpark@ibsimplant.com Tel. +82-42-933-2879 Fax. +82-42-933-2881

Device Information

Official Correspondent

Withus Group Inc April Lee 106 Superior Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122

Trade Name: Premilled Titanium Block System
Common Name: Dental Abutment System
Classification Name: Endosseous dental implant abutment ●
Product Code: NHA
Panel: Dental
Regulation Number: 872.3630 ●
Device Class: Class II
Date prepared: 07/20/2021

Predicate Devices:

Primary Predicate

K181037, DIO CAD/CAM Abutment by DIO CORPORATION

Reference Device

K140806, IBS Implant System by InnoBioSurg Co., Ltd.

K152520, Magicore Systyem by InnoBioSurg Co., Ltd.

K153350, IBS Implant System by InnoBioSurg Co., Ltd.

K162099, IBS Implant System II by InnoBioSurg Co., Ltd.

K173120, CCM Abutment System by InnoBioSurg Co., Ltd.

K192197. Magicore II System by InnoBioSurg Co., Ltd.

Indication for Use:

Premilled Titanium Block System is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

Implant System Compatibility	Implant Diameter (mm)	Platform Diameter (mm)
IBS Implant System	3.8/4.3/4.8/5.3/5.8/6.3	3.8/4.3/4.8/5.3/5.8/6.3
IBS Implant System	3.5/4.0/4.5/5.0/5.5/6.0/6.5	3.5/4.0/4.5/5.0/5.5/6.0/6.5
Magicore System	4.0/4.5/5.0/5.5/6.0/6.5	4.0/4.5/5.0/5.5/6.0/6.5
IBS Implant System II	3.5/3.8/4.0/4.5/5.0/5.5/6.0/6.5	3.5/3.8/4.0/4.5/5.0/5.5/6.0/6.5

Premilled Titanium Block System is intended for use with the IBS implant system, Magicore System and IBS Implant System II in the chart. All digitally designed abutments for use with Premilled Titanium Block System are intended to be manufactured at a Innobiosurg validated milling center.

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Device Description:

The subject Premilled Titanium Block System has two types of blocks, Premilled Titanium Block (Hex, Non-Hex) and Magic Premilled Titanium Block (Hex, Non-hex) based on the compatible implant system.

Patient-SpecificAbutment	Implant SystemCompatibility	CompatibleImplants	Implant Diameter (mm)	Platform Diameter(mm)
Premilled TitaniumBlock (Hex, Non-Hex)	IBS Implant System	K140806	3.8/4.3/4.8/5.3/5.8/6.3	3.8/4.3/4.8/5.3/5.8/6.3
Premilled TitaniumBlock (Hex, Non-Hex)	IBS Implant System	K153350	3.5/4.0/4.5/5.0/5.5/6.0/6.5	3.5/4.0/4.5/5.0/5.5/6.0/6.5
Hex)	IBS Implant System II	K162099	3.5/3.8/4.0/4.5/5.0/5.5/6.0/6.5	3.5/3.8/4.0/4.5/5.0/5.5/6.0/6.5
Magic PremilledTitanium Block(Hex, Non-Hex)	Magicore System	K152520	4.0/4.5/5.0/5.5/6.0/6.5	4.0/4.5/5.0/5.5/6.0/6.5

Patient-Specific Abutment is compatible with following Implant Systems:

Patient-Specific Abutments are supplied with previous cleared abutment screws in K173120 and K140806 and provided non-sterile.

Patient-Specific Abutment design Limitation (Unit :mm)
Block Type	Range (Diameter)	Range (Length)	Range (Angle)
Premilled Titanium Block (Hex, Non-Hex)	4.2~6.5	3.0~14.0	0~30°
Magic Premilled Titanium Block(Hex, Non-Hex)	4.7~6.5	3.0~12.0	0~25°

Manufacturing Parameters:

1. Premilled Titanium Block
  -Minimum and Maximum Gingival Height is 0.5-7.0mm.
Minimum diameter at abutment/implant interface is 2.485 to interface base
Maximum length of abutment from abutment/implant interface is 14.0 mm (Space allocated for each abutment along the titanium rod)
Minimum length of abutment post (length above the abutment collar/gingival height) is 4mm
Minimum wall thickness at abutment/implant interface is 0.517mm
Patient specific abutment compatible with Premilled Titanium Block has a maximum angle of 30.00
1. Magic Premilled Titanium Block
- Minimum and Maximum Gingival Height is 0-7.0mm.
- Minimum diameter at abutment/implant interface is 2.485 to interface base
- Maximum length of abutment from abutment/implant interface is 12.0 mm (Space allocated for each abutment along the titanium rod)
- Minimum length of abutment post (length above the abutment collar/gingival height) is 4mm
- Minimum wall thickness at abutment/implant interface is 0.62mm
- Patient specific abutment compatible with Magic Premilled Titanium Block has a maximum angle of 25.0°

Materials:

. Patient-specific abutment is fabricated from Ti-6A1-4V Eli (Conforming to ASTM Standard F136).

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Summaries of Technology Characteristics

The subject device is substantially equivalent to the current cleared devices. They are substantially equivalent in intended use, material and connection interfaces to the implants are individual diameter and connection type. Comparison demonstrating Substantial Equivalence follows:

	Subject Device				Primary Predicate Device
Applicant	InnoBioSurg Co., Ltd.				DIO Corporation
Trade Name	Premilled Titanium Block System				DIO CAM/CAM Abutment
510(k) No.	Not yet assigned				K181037
Classification Name	Endosseous Dental Implant, Abutment (872.3630)				Endosseous Dental Implant, Abutment (872.3630)
Product Code	NHA				NHA
Class	II				II
Material	Ti-6AL-4V ELI (ASTM F136)				Ti-6AL-4V ELI (ASTM F136)
Diameter (mm)	CAD/CAM Patient-Specific Abutment:3.5/3.8/4.0/4.8/4.8/5.0/5.3/5.5/5.8/6.0/6.3/6.5				CAD/CAM Patient-Specific Abutment:3.0/3.3/3.8/4.0/4.5/5.0/5.5/6.0/6.5/7.0
Sterile	Steam Sterilization by user(Provided Non-Sterile)				Steam Sterilization by user(Provided Non-Sterile)
Type of Retention	Screw-retained or cement retained				Screw-retained or cement retained
Abutment Seat	Sits on Taper			Sits on Taper
Anatomical Site	Oral Cavity			Oral Cavity
Constructions	Machined				Machined
	Premilled Titanium Block System is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.				DIO CAD/CAM Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
Indications For Use/Intended Use	Implant SystemCompatibility	Implant Diameter(mm)	Platform Diameter(mm)		Implant SystemCompatibility	Implant Diameter(mm)	Platform Diameter(mm)
	IBS ImplantSystem	3.8/4.3/4.8/5.3/5.8/6.3	3.8/4.3/4.8/5.3/5.8/6.3		UF(II) NarrowImplant System	3.0/3.3	3.0/3.3
	IBS ImplantSystem	3.5/4.0/4.5/5.0/5.5/6.0/6.5	3.5/4.0/4.5/5.0/5.5/6.0/6.5		UF Sub mergedImplant System	3.8/4.0/4.5/5.0/5.5/6.0/6.5/7.0	3.8/4.0/4.5/5.0/5.5/6.0/6.5/7.0
	MagicoreSystem	4.0/4.5/5.0/5.5/6.0/6.5	4.0/4.5/5.0/5.5/6.0/6.5		UF(II) ImplantSystem	3.8/4.0/4.5/5.0/5.5	3.8/4.0/4.5/5.0/5.5
	IBS ImplantSystem II	3.5/3.8/4.0/4.5/5.0/5.5/6.0/6.5	3.5/3.8/4.0/4.5/5.0/5.5/6.0/6.5		Patient specific abutment is intended for use with the UF implant system provided in the chart. All digitally designed abutments for use with DIOPremilled Titanium Block System is intended for use with the IBS implant system, Magicore System and IBS Implant System II in the chart. All digitally designed abutments for use with Premilled Titanium Block

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	System are intended to be manufactured at a Innobiosurg validated milling center.	CAD/CAM Abutments are intended to be manufactured at a DIO Corporation validated milling center.
SubstantialEquivalenceComparison	The subject patient specific abutment is substantially equivalent in designs, dimensions, material, indications, abutment seat, screw seat, anatomical site, connection, and technological characteristics with the identified primary predicate device. The patient specific abutment is similar in fundamental scientific technology to the predicate device in that they all have been designed, manufactured and tested in compliance with FDA's Class II special controls guidance document root-food endosseous dental implants and endosseous dental implant abutments.
	The Indications for Use of the subject and primary predicate device are identical other than the compatible implant bodies. This difference is mitigated by fatigue testing, and identification of reference device for compatible implant bodies. Both the predicate and subject devices are intended to be milled into patient specific abutments using CAD/CAM technology under the manufacturing control of the sponsor. Any differences in technology characteristics are accompanied by information that demonstrated the device is substantially equivalent as the predicate and do not raise different questions of safety and effectiveness than the predicate.

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Non-Clinical Testing

The subject device was tested to evaluate its substantial equivalence according to the following standards.

Fatigue Tests on subject device under the worst-case scenario according to ISO 14801:2016 .
Below tests were performed for predicate devices and leveraged for the subject device:
Biocompatibility testing according to ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-6:2007, ● and ISO 10993-10:2010 on abutments referenced in K152520 and K173120
End User Sterilization Validation Test Report according to ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1 referenced in K192197

The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device.

Non-clinical test data 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.

Clinical testing was not necessary to establish substantial equivalency of the device.

Conclusion

The Premilled Titanium Block System 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 devices. Therefore, the Premilled Titanium Block System and its predicates are substantially equivalent.

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)