The Hero II Dental Implant System and the UI Dental Implant System are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The Hero II Dental Implant System and the UI Dental Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.

Device Description

The Hero II Dental Implant System and the UI Dental Implant System are dental implant systems made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. The systems are similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of these systems have been treated with R.B.M (Resorbable Blast Media) for fixtures and TiN coating for abutments.

AI/ML Overview

The provided text describes a Special 510(k) submission (K130221) for the "Hero II Dental Implant System" and a renamed "UI Dental Implant System." This submission aims to add a new design fixture model and change a name, stating that the intended use and principal technology are unchanged from the unmodified device (K121047).

The document does not contain acceptance criteria or a study proving that the device meets those criteria, as typically understood for performance metrics like sensitivity, specificity, or reader agreement in AI/imaging devices. Instead, this 510(k) is a substantial equivalence determination based on comparison to a predicate device.

Here's an analysis based on the provided text, addressing the requested points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document does not define specific performance acceptance criteria (e.g., accuracy, precision) for the dental implant system itself, nor does it report performance metrics against such criteria in the context of a clinical study or statistical analysis. The "performance" mentioned refers to the device's characteristics and materials.

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

Not applicable. No "test set" in the context of evaluating performance metrics (like for an AI or diagnostic device) is mentioned. The submission is based on non-clinical testing and comparison to a predicate device.

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

Not applicable. No "ground truth" establishment by experts for a test set is described.

4. Adjudication Method for the Test Set

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document does not mention any MRMC study or any study comparing human readers with and without AI assistance. This device is a dental implant, not a diagnostic imaging device with an AI component in the described context.

6. Standalone (Algorithm Only) Performance Study

No. This is a physical medical device (dental implant), not an algorithm or AI system.

7. Type of Ground Truth Used

Not applicable. There is no mention of ground truth in the context of pathology, outcomes data, or expert consensus for assessing device performance. The "ground truth" in this submission relates to the device's physical and material characteristics being substantially equivalent to the predicate.

8. Sample Size for the Training Set

Not applicable. The device is a physical dental implant, not an AI model that requires a training set.

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

Not applicable.

Summary of Device Acceptance and Study (Based on the Provided Text):

The acceptance of the "Hero II Dental Implant System" and "UI Dental Implant System" in this 510(k) submission is based on demonstrating substantial equivalence to a previously cleared predicate device (K121047). The study that proves this is a comparison of the subject device's characteristics to those of the predicate device, supported by non-clinical testing.

Acceptance Criteria (Implicitly based on Substantial Equivalence):

Intended Use: Must be the same as the predicate device.
Technological Characteristics: Must be the same or similar to the predicate device, with any differences not raising new questions of safety or effectiveness.
Material Composition: Must be the same as the predicate device (Titanium 6AL 4V ELI alloy).
Performance Characteristics (Non-Clinical): Must meet the same non-clinical performance standards as the predicate device (e.g., cleanness after surface treatment, shelf-life, sterilization validation).

Study Proving Acceptance (Substantial Equivalence Determination):

Purpose of Submission: To add a new design fixture model and change a name to an unmodified device cleared under K121047. The intended use and principal technology of the subject device are stated to be the same as the unmodified device.
Device Description: The subject devices (Hero II and UI Dental Implant System) are dental implant systems made of Titanium 6AL 4V ELI alloy. Their surfaces are treated with R.B.M (Resorbable Blast Media) for fixtures and TiN coating for abutments. Size information for various diameters and lengths is provided.
Indications for Use: The indications for use are identical to those of the predicate device, covering use in partially or fully edentulous mandibles and maxillae, supporting single or multiple-unit restorations, and intended for single and two-stage surgical procedures with delayed loading.
Non-clinical testing:
- Tests Conducted: Energy Disperse X-ray micro analyzer (EDX) and Scanning Electron Microscopy (SEM) Analysis to verify cleanness after surface treatment, shelf-life testing, and sterilization validation.
- Rationale: These tests were conducted on the unmodified device (K121047) and reviewed in that previous 510(k) submission. The document states that "These characteristics have not been changed on the modified device; therefore it is substantially equivalent to the unmodified device in these regards."
Basis for Substantial Equivalence:
- Same intended use as predicate (K121047).
- Same fundamental scientific technology: threaded, root form implants made of titanium.
- Same internal hexagon abutment connection system with internal beveled interface.
- Both are bone-level implants with similar body shape design (straight walled neck and tapered body design).
- Difference: "minor thread design on the fixture." The submission implicitly argues this minor difference does not raise new questions of safety or effectiveness.
Conclusion: The submission concludes that the subject devices are substantially equivalent to the predicate devices based on identical intended use, operating principle, basic design, and material.

In essence, the "study" is a technical and regulatory comparison against a predicate device, demonstrating that the new/modified dental implant systems do not introduce new safety or effectiveness concerns compared to already cleared devices.

Summary

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510(k) Summary (K130221)

This summary of 510(K) - safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: 03/08/2013

l. Submitter

	Submitter
NameAddress	MEDIMECCA Co., Ltd.Daeryung Techno Twon 3-cha 104~105, 448, Gasan-dong, Guemcheon-gu, Seoul, 153-772 Rep, of Korea
PhoneFaxContact	Tel : +82-2-856-8282Fax : +82-2-856-0238Woo-Young Ha

U.S Agent/Contact Person

LK Consulting Group USA, Inc. 951 Starbuck St. Unit J, Fullerton, CA 92833 Priscilla Chung Fax: 714-409-3357 Phone: 714.869.3080 Email: juhee.c@lkconsultinggroup.com

1. Device
  Trade Name: Hero II Dental Implant System. UI Dental Implant System Common Name: Dental Implant Classification Name: Endosseous Dental Implant System Product Code: DZE, NHA Classification regulation: 21CFR872.3640

Predicate Device: 4.

HERO II and IS Dental Implant System (K121047) Osseofuse implant system (K110577)

510(k) Submission.

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Purpose of Submission 5.
The purpose of this Special 510(k) is to add a new design fixture model to the unmodified device (HERO II and IS Dental Implant System (K121047) and to change the name of IS Dental Implant System to UI Dental Implant System. The intended use and the principal technology of the subject device are the unmodified device.
Description: 6.
The Hero II Dental Implant System and the UI Dental Implant System are dental implant systems made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. The systems are similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of these systems have been treated with R.B.M (Resorbable Blast Media) for fixtures and TiN coating for abutments. The size information is as below.

Hero-II Fixture

Ø 3.75mm x (L) 8.5mm, 10.0mm, 11.5mm, 13.0mm, & 15mm Ø 4.00mm x (L) 8.5mm, 10.0mm, 11.5mm, 13.0mm, & 15mm 0 4.50mm x (L) 8.5mm, 10.0mm, 11.5mm, 13.0mm, & 15mm Ø 5.00mm x (L) 8.5mm, 10.0mm, 11.5mm, 13.0mm, & 15mm Ø 6.00mm x (L) 8.5mm, 10.0mm, 11.5mm,13.0mm, & 15mm

UI Fixture

Ø 3.5(Thread diameter) x (L) 8.5mm, 10.0mm, 11.5mm, & 13.0mm Ø 4.0 x (L) 7.3mm, 8.5mm, 10.0mm, 11.5mm, & 13.0mm . Ø 4.5 x (L) 7.3mm, 8.5mm, 10.0mm, 11.5mm, & 13.0mm 0 5.0 x (L) 7.3mm, 8.5mm, 10.0mm, 11.5mm, & 13.0mm 0 6.0 x (L) 7.3mm, 8.5mm, 10.0mm, 11.5mm, & 13.0mm

Abutments

Diameter Ø4mm ~ Ø7mm Cuff height 1~~4mm Height 4~~7mm

1. Indication for use:
  The Hero II Dental Implant System and the UI Dental Implant System are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The Hero II Dental Implant System and the UI Dental Implant System are for single and two stage surgical procedures. These systems are intended for

510(k) Submission.

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delayed loading.

Non-clinical testing 8.

The following nonclinical tests were conducted on the unmodified device and reviewed in the previous 510K submission (K121047). These characteristics have not been changed on the modified device; therefore it is substantially equivalent to the unmodified device in these regards.

Energy Disperse X-ray micro analyzer (EDX) and Scanning Electron Microscopy (SEM) Analysis to verify cleanness after surface treatment

Shelf life testing
Sterilization validation

Basis for Substantial Equivalence

The Hero II Dental Implant System and the UI Dental Implant System have the same intended use as the identified predicate device (K121047). The Hero II / UI Dental Implant system and the unmodified devices are the same in fundamental scientific technology in that they are all threaded, root form implants constructed of titanium. They all share same internal hexagon abutment connection system with internal beveled interface. The subject and the unmodified devices are both bone-level implants that share similar body shape design such as straight walled neck and tapered body design.

The difference is the minor thread design on the fixture.

Conclusion

The subject devices and the predicate devices have the same intended use and have the same technological characteristics. The subject and the predicate implants are all made of commercially pure titanium and have the same surface treatments.

Overall, the Hero II Dental Implant System and the UI Dental Implant System have the following similarities to the predicate devices:

- have the same intended use,
- use the same operating principle,
- incorporate the same basic design,
- incorporate the same material.

Based on the similarities, we conclude that the Hero II Dental Implant System and the Ul Dental Implant System are substantially equivalent to the predicate devices.

510(k) Submission.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 21, 2013

Medimecca Company, Limited C/O Ms. Priscilla Chung Regulatory Affairs Consulting LK Consulting Group USA, Incorporated 951 Starbuck Street, Unit J Fullerton CA 92833

Re: K130221

Trade/Device Name: Hero II Dental Implant System UI Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: February 14, 2013 Received: February 20, 2013

Dear Ms. Chung:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Isting 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.

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

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Page 2 - Ms. Chung

or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Kwame O.Ulmer for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K13022 510(k) Number (if known):

Hero II Dental Implant System Device Name: UI Dental Implant System

Indications For Use:

Prescription Use 1 (Per 21 CFR 801 Subpart D)

AND

Over-The Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary S. Runner -S
2013.03.14 07:42:14 -04'00'

(Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices

K130221 510(k) Number:

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.