The One Plus Implant System is intended to use in the treatment of missing teeth to support prosthetic device, such as artificial teeth, in order to restore mastication in partially edentulous patients. 3.0mm diameter implants are intended to be used in central or lateral mandibular incisors. The One Plus Implant System is intended for single use only. It is for delayed loading.

Device Description

The One Plus Implant System is a dental implant system made of Titanium 6AL 4V ELI Gr.23 alloy intended to be surgically placed in the bone of the upper or lower jaw arches. The system is similar to other commercially available products based on the intended use, the technology used, the material composition employed and performance chracteristics, The surface of this system has been treated with R.B.M and the abutment part has TiN coating on it. The One Plus Implant System is available in the following sizes. Sizes: 3.00mm (Dia.) x 11.5/13/14.5 3.75mm (Dia.) x 11.5/13/14.5 4.50mm (Dia.) x 11.5/13/14.5 5.25mm (Dia.) x 11.5/13/14.5

AI/ML Overview

The provided document is a 510(k) premarket notification for the "One Plus Implant System," a dental implant device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with acceptance criteria and results as typically seen for novel medical device approvals or AI/algorithm-based devices.

Therefore, the document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of diagnostic accuracy, sensitivity, specificity, or similar metrics. It is a regulatory submission for a physical device, and the "testing" mentioned is primarily related to manufacturing, sterility, and material properties to ensure safety and performance equivalence, not a clinical performance study as would be conducted for a diagnostic AI.

Here's a breakdown of why the requested information cannot be fully provided from this document:

A table of acceptance criteria and the reported device performance: Not applicable. The document assesses "substantial equivalence" based on design, materials, intended use, and manufacturing processes, not on a set of clinical performance metrics with pre-defined acceptance criteria. The non-clinical testing mentioned (sterilization, shelf life, chemical/SEM analysis) is to ensure the product itself is safe and functions as intended, not to measure a clinical performance against a threshold.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. There is no "test set" in the context of clinical performance data in this submission. The non-clinical testing refers to lab tests on the device itself.
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 ground truth established by experts for clinical performance in this submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 physical dental implant, not an AI-powered diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical performance. The "ground truth" here would be established procedures for manufacturing and testing of medical devices (e.g., sterility standards, material composition verification).
The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable.

What the document does provide regarding "testing" and "performance":

The document states under "8. Non-Clinical Testing":

Sterilization validating testing: Performed in accordance with ISO 11137-1, ISO 11137-2, and ISO 11137-3. This demonstrates that the device can be effectively sterilized.
Accelerated shelf life testing: Performed in accordance with ASTM1980-07, ISO 11607-1, ISO 11737-1, ISO 11737-2. This demonstrates the stability of the device over its intended shelf life.
Chemical and SEM image analyses: Performed to verify no residual material after RBM treatment on the fixture. This ensures the surface treatment is properly applied and safe.

The "acceptance criteria" for these tests would be the specific standards and thresholds defined within the cited ISO and ASTM documents. The "reported device performance" would be that the device met these standards, allowing the conclusion of substantial equivalence for these aspects. However, these are not clinical performance metrics.

Summary

{0}------------------------------------------------

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

September 19, 2014

OsseoFuse, Inc. C/O Priscilla Chung LK Consulting Group USA, Inc. 2651 East Chapman Avenue, Suite 110 Fullerton, CA 92831

Re: K133050

Trade/Device Name: One Plus Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endossesous Dental Implant Regulatory Class: II Product Code: DZE Dated: August 20, 2014 Received: August 21, 2014

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.

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

{1}------------------------------------------------

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 Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mary S. Runner -S

Erin I. Keith, M.S Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page

510(k) Number (if known) K133050

Device Name One Plus Implant System

Indications for Use (Describe)

The One Plus Implant System is intended to use in the treatment of missing teeth to support prosthetic device, such as artificial teeth, in order to restore mastication in partially edentulous patients. 3.0mm diameter implants are intental or lateral mandibular incisors. The One Plus Implant System is intended for single use only. It is 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)

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)

{3}------------------------------------------------

510(k) Summary

(K133050)

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

Date: 09/17/2014

1. Applicant / Submitter

OsseoFuse, Inc.

5023 North Parkway Calabasas. Calabasas, CA 91302 Tel. 888.446.9995 Fax. 310.356.3183

2. Submission Correspondent

LK Consulting Group USA, Inc. 2651 E Chapman Ave. Ste 110, Fullerton CA 92831 Priscilla Chung Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c(@lkconsultinggroup.com

3. Device

Trade Name: One Plus Implant System
· Common Name: Dental Implant
Classification Name: Endosseous Dental Implant System
· Product Code: DZE
· Classification regulation: 21CFR872.3640

4. Predicate Device:

· MS System by OSSTEM IMPLANT CO., LTD (K083067)
· S-MINI IMPLANT SYSTEM by NEOBIOTECH CO., LTD (K112540)
· OSSEOFUSE DENTAL IMPLANT SYSTEM by Dynamic Innovations Inc. (K110577)
· Spectra System (ScrewDirect Implant) by Implant Direct LLC (K061319)
· Replace One Piece Implant by NOBEL BIOCARE UAS INC. (K023952)
· Lifecore PrimaSolo One-Piece Implant System by Lifecore Biomedical, Inc.(K050506)

{4}------------------------------------------------

5. Description:

The One Plus Implant System is available in the following sizes.

Sizes: 3.00mm (Dia.) x 11.5/13/14.5 3.75mm (Dia.) x 11.5/13/14.5 4.50mm (Dia.) x 11.5/13/14.5 5.25mm (Dia.) x 11.5/13/14.5

6. Indication for use:

7. Basis for Substantial Equivalence

The subject device is substantially equivalent to the noted predicate devices based on tabulated device specifications and properties presented. Based on the comparison analysis, the identical intended use, comparable technological characteristics, and similar general design features, the subject device is substantially equivalent to the predicate devices. There are no significant differences between the One Plus Implant System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to the predicate devices in design, function, material and intended use.

The comparison chart can be found on the following pages.

{5}------------------------------------------------

Comparison Chart

	Subject Device	Predicate Device 1	Predicate Device 2	Predicate Device 3	Predicate Device 4
510(K) Number	K133050	K083067	K112540	K110577	K061319
Device Name	One Plus Implant System	MS System	S-MINI IMPLANTSYSTEM	OSSEOFUSE DENTALIMPLANT SYSTEM	Spectra System(ScrewDirect Implants)
Applicant	OsseoFuse Co., Ltd.	OSSTEM Implant Co.,Ltd.	NEOBIOTECH CO., LTD.	Dynamic Innovations Inc.	Implant Direct LLC
ContractManufacturer	KJ Meditech Co., Ltd.	-	-	KJ Meditech Co., Ltd.	-
Indications forUse	The One Plus ImplantSystem is intended to usein the treatment ofmissing teeth to supportprosthetic device, such asartificial teeth, in order torestore mastication inpartially edentulouspatients. 3.0mm diameterimplants are intended tobe used in central orlateral mandibularincisors. The One PlusImplant System isintended for single useonly. It is for delayedloading.	The MS System(Denture) is intended tobe place in the bone ofthe upper or lower jawarches to provide supportthe prosthetic devices torestore the patient'schewing function,including the denturestabilization. MS System(Denture) is intended forsingle use only.The MS System (NarrowRidge) is intended to usein the treatment ofmissing mandibularcentral and lateralincisors to supportprosthetic device, suchas artificial teeth, inorder to restore chewingfunction in partiallyedentulous patients. MSSystem (Narrow Ridge)is intended for single useonly. It is not for	The Cement type isindicated for use in thetreatment of missingmaxillary lateral incisors orthe mandibular central andlateral incisors to serve astemporary supportprosthetic devices duringthe healing phase ofpermanent endosseousdental implant, such asartificial teeth, in order torestore chewing function inpartially edentulouspatients.	The OsseoFuse DentalImplant System is intendedfor use in partially or fullyedentulous mandibles andmaxillae, in support ofsingle or multiple-unitrestorations including:cemented retained, screwretained, or overdenturerestorations, and terminalor intermediate abutmentsupport for fixedbridgework. This system isdedicated for one and twostage surgical proceduresand not dedicated forimmediate loading. Thissystem is intended fordelayed loading.	The Spectra DentalImplant System consists ofone-piece or two-pieceimplants for single-stage ortwo-stage surgicalprocedures that areintended for use inpartially or fullyedentulous mandibles andmaxillae, in support ofsingle or multiple-unitrestorations and terminalor intermediate abutmentsupport for fixedbridgework. They may beplaced in immediatefunction if initial implantstability can beestablished.The ScrewDirect 3.0mmimplant is indicated for:1. An artificial rootstructure for single toothreplacement of mandibularcentral and lateral incisors
		immediate loading.			and maxillary lateralincisors.2. Multiple toothreplacements or denturestabilization.
Design	One Piece Implant	One Piece Implant	One Piece Implant	Two Piece Implant	One Piece Implant
Appearance	Image: One Piece Implant	Image: One Piece Implant	Image: One Piece Implant	Image: Two Piece Implant	Image: One Piece Implant
Material	Ti 6Al 4V ELI, Gr.23	Titanium Alloy	Titanium Gr. 4	Ti 6Al 4V ELI, Gr.23	Titanium Alloy
SurfaceTreatment	•RBM Treatment on thefixture body•TiN coating on theabutment	RBM Treatment on thefixture body	RBM Treatment on thefixture body	•RBM Treatment on thefixture body•TiN coating on theabutment	Roughened - HA blasted
Implant Sterile	Yes	Yes	Yes	Yes	Yes
SterilizationMethod	Gamma	Gamma	Gamma	Gamma	Gamma
ImplantDiameters	3.00mm, 3.75mm,4.50mm, 5.25mm	2.50mm 3.00mm	2.0mm, 2.5mm, 3.0mm,3.5mm	3.75mm, 4.1mm, 4.5mm,5.25mm	3.0mm, 3.7mm, 4.7mm,5.7 mm
ImplantLengths	11.5mm, 13mm, 14.5mm	10.0 mm, 13.0mm,15.0mm	7.0 - 15.00 mm	8.5mm - 16.0 mm	10mm, 13mm, 16mm
Product Code	DZE	DZE	DZE	DZE, NHA	DZE

{6}------------------------------------------------

{7}------------------------------------------------

	Predicate Device 5	Predicate Device 6
510(K) Number	K023952	K050506
Device Name	Replace One Piece Implant	Lifecore PrimaSolo™ One-Piece Implant System
Applicant	NOBEL BIOCARE UAS INC.	LIFECORE BIOMEDICAL, INC.
Indications for Use	The Replace One Piece Implant is a threadedone-piece implant with an integrated abutment,designed for single-stage surgical procedureand cemented restorations. The Replace OnePiece Implant is intended for immediate loadon single tooth and multiple tooth applicationsin good quality bone, to restore chewingfunction.	Lifecore Biomedical Dental Implant Systemimplants are intended for use in partially or fullyedentulous mandibles and maxillae, in support ofsingle or multiple-unit restorations including;cement retained, screw retained, or overdenturerestorations, and terminal or intermediateabutment support for fixed bridgework.Specific Intended Uses: The PrimaSolo One-Piece (3.5-5.0mm) Implant is a threaded one-piece implant with integrated abutment designedfor single-stage surgical procedure and cementedrestorations. The PrimaSolo One-Piece Implant isintended for immediate placement and can berestored with a temporary prosthesis in singletooth and multiple tooth applications with goodquality bone.The PrimaSolo One-Piece (3.0mm) Implant is athreaded one-piece implant with an integratedabutment designed for single-stage surgicalprocedure and is indicated for use in the treatmentof missing maxillary lateral incisors or themandibular central and lateral incisors to support
		prosthetic devices, such as artificial teeth, inorder to restore chewing function in partially
		edentulous patients. Mandible central and lateralincisors must be splinted if using two or more
		3.0mm implants adjacent to one other.
Design	One Piece Implant	One Piece Implant

{8}------------------------------------------------

Appearance
Material	Titanium Gr. 4	Titanium Alloy
Surface Treatment		RBM Treatment on the fixture body
Implant Sterile	Yes	Yes
Sterilization Method
Implant Diameters	3.5mm, 4.3mm, 5.0mm,	3.0mm, 3.5mm, 4.1mm, 5.0mm
Implant Lengths	10mm, 13mm, 16mm	10.0 mm、11.5mm 13.0mm、15.0mm

{9}------------------------------------------------

8. Non-Clinical Testing

· Sterilization validating testing has been performed in accordance with ISO 11137-1, ISO 11137-2 and ISO 11137-3.
· Accelerated shelf life testing has been performed in accordance with ASTM1980-07, ISO 11607-1, ISO 11737-1, ISO 11737-2
Chemical and SEM image analyses have been performed to verify that there is no residual after RBM treatment on the fixture.

There might be differences in sterilization parameters, shelf life and manufacturing processes between the subject device and the predicate devices, however, the test results supported that the subject device is substantially equivalent to the predicate devices.

9. Conclusion

The subject device and the predicate devices have intended use and have similar technological characteristics.

Overall, the One Plus Implant System has the following similarities to the predicate devices:

· 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 One Plus Implant System is substantially equivalent to the predicate devices.

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.