NEOPLANT Internal Hex Implant system is intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

Device Description

NEOBIOTECH Internal Hex Implant System(NEOPLANT) consists of two-stage, root-form tapered and straight walled threaded dental implant and associated abutment system, which provide the clinical with Screw-Retained(UCLA, Cement-on Crown), and overdenture Snap Abutments. The System also includes surgical and restorative instrumentation: twist drills, surgical taps, surgical depth probe, depth gauge, abutment drivers, ratch-type drivers, open end wrench, and hand-piece adapters. NEOBIOTECH implant system(NEOPLANT) is available with a S.L.A. roughened surface. All implants have an internal hexagon as a connection and as an anti-rotational feature for the prosthetics.

AI/ML Overview

The provided text details a 510(k) summary for the NEOPLANT Implant System. However, it explicitly states that "Laboratory testing was conducted to determine device functionality and conformance to design input requirements" but does not provide any specific quantitative acceptance criteria or reported performance data from these tests.

Furthermore, this 510(k) is a Traditional 510(k) based on substantial equivalence to predicate devices, rather than a De Novo submission or a PMA, which would typically contain detailed clinical study data showcasing device performance against specific criteria. The submission largely focuses on comparing the NEOPLANT system to already approved predicate devices (3i Dental Implants) to demonstrate similar fundamental scientific technology, materials, and intended use.

Therefore, many of the requested details regarding acceptance criteria, study methodologies, and performance data are not available within the provided document.

Here is a summary of what can be extracted and what is missing:

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

Acceptance Criteria (Not explicitly stated in document)	Reported Device Performance (Not explicitly stated in document)
Functionality	"Laboratory testing was conducted to determine device functionality and conformance to design input requirements." (No specific results provided.)
Conformance to design input requirements	"Laboratory testing was conducted to determine device functionality and conformance to design input requirements." (No specific results provided.)

Explanation: The document mentions that laboratory testing was conducted for functionality and conformance to design input requirements, but it does not specify what those design input requirements were, nor does it provide any quantitative results or acceptance thresholds. The primary basis for approval in this 510(k) is substantial equivalence to predicate devices, not meeting specific performance criteria demonstrated by new data.

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

Sample size for test set: Not applicable and not provided. This 510(k) relies on substantial equivalence to predicate devices, not on a clinical test set from a new study.
Data provenance: Not applicable. The document refers to "laboratory testing" but does not specify the details of any data generated or where it originated, as it's not a clinical trial.

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. There is no mention of a test set with human-established ground truth. The submission focuses on device characteristics and comparison to predicates.

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

Not applicable. No test set requiring expert adjudication is described.

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 is a medical device (dental implant) and not an AI/Software as a Medical Device (SaMD) that would involve human readers or AI assistance.

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

Not applicable. This is a physical medical device, not a standalone algorithm.

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

Not applicable. There is no mention of ground truth in the context of performance evaluation, as the submission relies on substantial equivalence.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI/machine learning model that would require a training set.

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

Not applicable. As above, this is not an AI/machine learning model.

Conclusion:

The provided 510(k) summary for the NEOPLANT Implant System is a "Substantial Equivalence" submission. This type of submission aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device, rather than providing extensive de novo performance data against specific acceptance criteria from clinical studies. While the document states "Laboratory testing was conducted to determine device functionality and conformance to design input requirements," it does not elaborate on the specific acceptance criteria, methodology, or the results of these tests. Therefore, most of the detailed information requested regarding study design, sample sizes, ground truth, and expert involvement is not present in this document.

Summary

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NOV - 2 2004

K042334

1. 510(K) Summary
  NEOBIOTECH. Co.Ltd. 510(K) Premarket Notification NEOPLANT Implant System

510(K) Summary

510(K) SUMMARY AND CERTIFICATION

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR & 807.93

11-1. Submitter	NEOBIOTECH. Co.Ltd.8th. Floor Jeongkok B/D, 44-25Yeou-leudong, Youngdeungpo-Gu,Seoul city, South Korea
11-2. Contact Person	Dae K Chang9778 Katella Ave. Ste. 215,Anaheim, CA 92804Phone: 714-537-0600Fax: 714-537-0601
11-3. Date Prepared	August 25, 2004
11-4. Device Name	NEOPLANT IMPLANT SYSTEM
11-5. Classification Name	Endosseous Dental Implant System
11-6. Device Classification	Class IIIDental Devices panel21 CFR § 872.3640Regulation Number: 872.3640
1-7. Predicate Devices	3i Dental Implants(K86063, K874590, K950204, K955428)

11-8. Performance

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Laboratory testing was conducted to determine device functionality and conformance to design input requirements.

11-9. Device Description

11-10. PACKING/LABELING/PRODUCT INFORMATION

NEOBIOTECH Internal Hex Implant System (NEOPLANT) will be packaged.

11-11. Intended Use

NEOBIOTECH Internal Hex Implant System(NEOPLANT) is intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

11-12. Substantial Equivalence Comparison

NEOBIOTECH Internal Hex Implant System(NEOPLANT) and the predicate implants share a substantially equivalent intended use. The 3i Dental Implants.(K86063, K874590, K950204, K955428) The screw -Vent and NEOBIOTECH Implant system(NEOPLANT) are similar in fundamental scientific technology in that they are all threaded, root form implants constructed of titanium with roughened surfaces. The subject and predicate devices are similar in size and materials. All three system offers abutment systems for cement-retained, screw-retained and overdenture restorations as well as associated accessories and instruments. When compared with the predicate devices, no new questions of safety or effectiveness have been raised for the Implant system.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 three lines forming its body and wing. The eagle faces left and is positioned in the center of a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 2 2004

NEOBIOTECH Company Limited C/O Mr. Dae-Kyu Chang 9778 Katella Avenue Suite 215, Anaheim, California 92804

Re: K042339

Trade/Device Name: NEOPLANT IMPLANT SYSTEM Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: August 25, 2004 Received: September 7, 2004

Dear Mr. Chang:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Mr. Chang

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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NEOBIOTECH. Co.Ltd. 510(K) Premarket Notification NEOBIOTECH Implant System

510(K) Summary

INDICATIONS FOR USE STATEMENT

4 23339

510(k) Number (If known):

Device Name : NEOPLANT IMPLANT SYSTEM

Intended use/ Indications for Use:

510(k) Number:

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED

Rx ✓

Susan Suarez

Division of Anesthesiology, General Hospital, Infection Control, Denta

510(k) Number: ka12334

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.