UD Implant System is intended for use in partially or fully edentulous mandibles and maxilla, in support of single of multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. UD Implant System is for single stage and two stage surgical procedures. This system is intended for delayed loading.

Device Description

UD Implant System is a dental implant system made of titanium (Fixture: ASTM F136 / Prosthetic Abutment: ASTM F136, ASTM F67 Gr 4) intend to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. This device may be used to replace one or more missing teeth. Its material, structure and intended use are substantial equivalence with the predicate device.

AI/ML Overview

The provided text describes a 510(k) summary for the "UD Implant System," a dental implant device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a study proving a device meets specific acceptance criteria based on performance metrics.

Therefore, many of the requested sections about clinical study details (sample size, ground truth, expert adjudication, MRMC studies, standalone performance, training set) cannot be answered. The provided text outlines non-clinical testing conducted to validate safety, but not performance-based acceptance criteria against clinical outcomes.

Here's a breakdown of what can be extracted and what cannot, based on your request:

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

This information is not explicitly provided in terms of performance metrics or acceptance criteria for clinical efficacy. The summary focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and intended use, and provides a list of non-clinical tests for safety and physical characteristics.

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

Not applicable. No clinical test set or data provenance is mentioned as this is a 510(k) submission focusing on substantial equivalence through non-clinical testing and comparison to a predicate device.

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)

Not applicable. No clinical test set or ground truth established by experts is mentioned.

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

Not applicable. No clinical test set or adjudication method is mentioned.

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 dental implant, not an AI-assisted diagnostic tool, so an MRMC study is not relevant.

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

Not applicable. This device is a dental implant, not an algorithm.

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

Not applicable for clinical performance. The "ground truth" or basis for acceptance in this submission relates to the adherence to standards for materials, mechanical properties, and biocompatibility in non-clinical testing, and the substantial equivalence to a predicate device.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is a physical medical device, not a machine learning model.

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

Not applicable.

Summary of Device and Evidence Presented (based on available information):

Device: UD Implant System (Endosseous Dental Implant)

Purpose of Submission: Demonstrate substantial equivalence to a predicate device (Hero II and IS Dental Implant System by KJ Meditech Co., Ltd. K121047) to market the device.

Evidence for Substantial Equivalence:

Intended Use: Identical to the predicate device.
Operating Principle: Same.
Basic Design: Same.
Material: Titanium (ASTM F136 / ASTM F67 Gr 4) - similar to the predicate's Titanium 6Al 4V ELI Alloy.
Surface Treatment: R.B.M. (Same as predicate).
Structure: Internal Hexagon connection, self-taping cutting edge threads (Same as predicate).
Dimensions: Similar range of diameters and lengths for fixtures and abutments.
Surgery Type: One stage, Two stages (Same as predicate).
Sterilization: Gamma radiation (Same as predicate).
Shelf-life: 5 years (Same as predicate).

Non-clinical Testing Conducted (for safety, not performance against clinical acceptance criteria):

Physical tests: visual, packaging, packaging seal efficacy, dimension, sterility (direct transfer method).
Surface treatment tests: roughness average, developed surface area ration, surface characteristics (SEM), surface composition analysis (EDX).
Mechanical properties tests: adaptation accuracy (Implant to abutment comparability), 35° compressive loads, torsional breaking force, removal torque force, fatigue test.
Sterilization validation and shelf life tests.
Biocompatibility tests (in accordance with ISO10993 series).

The 510(k) summary concludes that the UD Implant System is substantially equivalent to the predicate device based on these comparisons and non-clinical tests. It does not contain information about clinical performance studies with specific acceptance criteria that would typically be associated with AI/software medical devices or new device types requiring de novo clinical validation.

Summary

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510(k) Summary

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

Date: 12/04/2013

1. Applicant / Submitter

MEDIMECCA Co., Ltd. Daeryung Techno Twon 3-cha 104~105. 448, Gasan-dong, Guemcheon-gu, Scoul, 153-772 Rep. of Korea

Tel : +82-2-856-8282 Fax : +82-2-856-0238 Contact: Woo-young Ha

2. U.S Agent/Submission Correspondent

DEC 0 5 2013

LK Consulting Group USA, Inc. 1515 E Katella Ave. Unit 2115, Anaheim, CA 92805 Priscilla Chung Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com

3. Device

Proprietary/Trade Name	UD Implant System
Common/Usual Name	Dental Implant
Classification Name	Endosseous Dental Implant
Classification Product Code	DZE, NHA
Classification regulation	21CFR872.3640
Class	II

4. Predicate Device:

Hero II and IS Dental Implant System by KJ Meditech Co., Ltd. (K121047)

5. Description:

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6. Model List

(1) Fixture

Diameter : 0 3.75mm, 0 4.0mm, 0 4.5mm, 0 5.0mm, 0 6.0mm Length : 7.3mm, 8.5mm, 10.0mm, 11.5mm, 13mm

*7.3mm length is not available for the 3.75 diameter implant fixtures.

(2) Abutments

No	Component	Description
1	Cover Screw	TypeInternal
		Size(Diameter)2.8mm, 3.37mm
2	Healing Abutment	TypeInternal
		Size(Diameter)4.0mm, 4.5mm, 5.5mm, 6.5mm
3	Dual Abutment	TypeInternal Hex, Internal Non-Hex
		Size(Diameter)4.0mm, 4.5mm, 5.5mm, 6.5mm
4	Combi Abutment	TypeInternal
		Size(Diameter)4.0mm, 4.5mm, 5.5mm, 6.5mm
5	Angled Abutment	TypeInternal Hex, Internal Non-HexAngle: 15°, 25°
		Size(Diameter)4.5mm, 5.5mm
6	Milling Abutment	TypeInternal Hex, Internal Non-Hex
		Size(Diameter)4.0mm, 4.5mm, 5.5mm, 6.5mm
7	Temporary Abutment	TypeInternal Hex, Internal Non-Hex
		Size(Diameter)4.0mm, 4.5mm
8	Ball Abutment	TypeInternal Hex, Internal Non-Hex
		Size(Diameter)3.5mm

7. Indication for use:

8. Basis for Substantial Equivalence

The UD Implant System is substantially equivalent to previously marketed devices. The design features and sizing of the components were compared and the UD Implant System found to be substantially the same as the predicate device. It is indicated for the same intended use. There are no significant differences between the UD Implant System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to other devices in design, function, material and intended use.

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Device Name	UD Implant System	HERO II Dental Implant SystemIS Dental Implant System
510(k) no	-	K121047
Applicant	MEDIMECCA CO LTD	KJ Meditech Company, Limited.
Classification	Endosseous dental implant(Class 11, 21CFR872.3640)	Endosseous dental implant(Class 11, 21CFR872.3640)
Material	Titanium(ASTM F136, ASTM F67 Gr 4)	Titanium 6Al 4V ELI Alloy
Surgery Type	One stage, Two stages	One stage, Two stages
Structure	Internal Hexagon connectionSelf-taping cutting edge threads	Internal Hexagon connectionSelf-taping cutting edge threads
Dimension	Fixture:Diameter :Ø 3.75mm, Ø 4.0mm, Ø 4.5mm,Ø 5.0mm. Ø 6.0mmLength :7.3mm, 8.5mm, 10.0mm, 11.5mm,13mmAbutmentDiameter : Ø 4~6.5mm	Fixture:Diameter :Ø 3.75mm, Ø 4.0mm. Ø 4.5mm.Ø 5.0mm. Ø 6.0mmLength :7.3mm, 8.5mm, 10.0mm, 11.5mm,13mmAbutmentDiameter : Ø 4~7mm
Surface(Fixture)	R.B.M.	R.B.M.
Intended use	intended for use in partially or fullyedentulous mandibles and maxilla,in support of single of multiple-unitrestorations including; cementedretained, screw retained, oroverdenture restorations, andterminal or intermediate abutmentsupport for fixed bridgework. UDImplant System is for single stageand two stage surgical procedures.This system is intended for delayedloading.	intended for use in partially or fullyedentulous mandibles and maxilla,in support of single of multiple-unitrestorations including; cementedretained, screw retained, oroverdenture restorations, andterminal or intermediate abutmentsupport for fixed bridgework.HERO II Dental Implant Systemand IS Dental Implant System is forsingle stage and two stage surgicalprocedures. This system is intendedfor delayed loading.
Sterilization	Gamma radiation	Gamma radiation
Shelf-life	5 years	5 years

9. Non-clinical Testing

The following non-clinical testing was conducted to validate its safety.

Physical tests including visual test, packaging test, packaging seal efficacy test, dimension test, and sterility test (direct transfer method)
Surface treatment tests including roughness average test, developed surface area ration test, surface characteristics test (SEM), and surface composition analysis test (EDX)
Mechanical properties test including adaptation accuracy test (Implant to abutment comparibility). 35° compressive loads test, torsional breaking force test, removal torque force test. and fatigue test
Sterilization validation and shelf life tests
The biocompatibility tests have been performed in accordance with ISO10993 series.

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10. Conclusion

The subject device and the predicate device have the same intended use and have the same technological characteristics. The subject and predicate implants are all made of the titanium alloys and have the same surface treatments. The subject and the predicate devices encompass the similar range of physical dimensions, including diameter and length of the implants, and diameter of the abutments.

Overall, the UD Implant System has the following similarities to the predicate device: * has the same intended use.

- uses the same operating principle.
- incorporates the same basic design.
- incorporates the same material and the surface treatment.

Based on the similarities, we conclude that the UD Implant System is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring MD 20993-00002

December 5, 2013

MEDIMECCA Company, Limited C/O Ms. Priscilla Chung Regulatory Affairs Consulting LK Consulting Group USA, Incorporated 1515 East Katella Avenue, Unit 2115 Anaheim, CA 92805

Re: K131682

Trade/Device Name: UD Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: November 4, 2013 Received: November 7, 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, 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 (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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 -S for

Erin I. Keith, M.S. Division 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

510(k) Number (if known) K131682

Device Name

UD Dental Implant System

Indications for Use (Describe)

UD Implant System is intended for use in partially or fully edentulous maxilla, in support of single of multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. UD Implant System is for single stage surgical procedures. This system is intended for delayed loading.

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)

Form Approved: OMB No. 0910-0120

Expiration Date: December 31, 2013

See PRA Statement on last page.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Image /page/6/Picture/13 description: The image shows the name "Susan Runner DDS, MA" in a stylized font. Next to the name is "Mary S. Runner -S". Below this is the date and time "2013.12.05 08:45:15 -05'00'".

FORM FDA 3881 (9/13)

in Services (301) 443-67-67-0

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.