The EM Provisional is intended to be loaded immediately in partially or fully edentulous mandibles and maxilla to serve as temporary support for provisional prosthetic device during the healing phase of a permanent endosseous dental implant(s).

Device Description

The EM Provisional is a dental implant made of titanium alloy (Ti-6Al-4V) and is supplied sterile. The surface is machined finished and is intended to be surgically placed in the bone of the upper or lower jaw arches.

AI/ML Overview

This document is a 510(k) Premarket Notification from Hiossen, Inc. for their dental implant device, EM Provisional. According to the provided text, this submission argues for "substantial equivalence" of the EM Provisional to existing predicate devices, rather than presenting a study proving a device meets specific performance criteria through a clinical or non-clinical study that would generate the kind of data typically found in an AI/software as a medical device (SaMD) submission.

Therefore, the requested information, specifically regarding acceptance criteria, device performance from a test set, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details, is not available in this document. This document primarily focuses on demonstrating that the new device (EM Provisional) is structurally and functionally equivalent to already cleared devices, meaning it does not pose new or increased risks and performs similarly.

Instead of performance metrics from a new study, the document makes the following arguments for substantial equivalence:

1. Acceptance Criteria and Device Performance (as presented in this substantial equivalence argument, not a performance study):

The "acceptance criteria" here relate to the device being substantially equivalent to its predicate. The "performance" is demonstrated by asserting similarity in design, materials, and manufacturing, rather than through measured accuracy, sensitivity, or specificity.

Acceptance Criteria (for Substantial Equivalence Claim)	Reported Device "Performance" (Comparison to Predicate)
Intended Use Equivalence	The EM Provisional is intended to be loaded immediately in partially or fully edentulous mandibles and maxilla to serve as temporary support for provisional prosthetic device during the healing phase of a permanent endosseous dental implant(s). This is identical to the Intended Use of the primary predicate device (MS System (Provisional) K072871).
Technology/Design Equivalence	Both EM Provisional and the predicate MS System (Provisional) are: - Screw form - One-piece fixture and abutment - Available in diameters: Ø1.8, Ø2.5 mm - Available in lengths: 10.0, 13.0, 15.0 mm
Material Equivalence	Both EM Provisional and the predicate MS System (Provisional) are made of Titanium alloy Ti-6Al-4V (ASTM F 136).
Surface Finish Equivalence	Both EM Provisional and the predicate MS System (Provisional) have a machined finished surface.
Sterilization Equivalence	Both EM Provisional and the predicate MS System (Provisional) are Radiation Sterile, and the EM Provisional uses the same manufacturing process, material, and sterilize barrier system as the predicate.
Packaging Equivalence	EM Provisional packaging is consistent with the predicate: Secured in plastic ampule, housed in Tyvek-lidded blister tray, placed in a tamper-evident outer package (predicate uses "outer box" but intent is the same). The reference device (Hiossen Implant System K140934) also uses similar packaging.
Risk Equivalence	The proposed device does not pose any new or increased risks as compared to the legally marketed predicate and reference devices. Asserted due to identical manufacturing processes, materials, and design to the predicate, making re-testing for biocompatibility, sterilization validation, surface treatment characterization, fatigue, compressive strength, and pull-out unnecessary per the "least burdensome principle." No clinical performance reports were submitted, reinforcing reliance on equivalence to existing devices.

2. Sample size used for the test set and the data provenance:
Not applicable. There was no "test set" in the context of an AI/SaMD performance study. The submission relies on pre-existing data and knowledge of the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No new ground truth was established for a performance study. Equivalence is asserted based on engineering and material comparisons.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No adjudication process for a test set was performed.

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 physical dental implant, not an AI/SaMD.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical dental implant, not an AI/SaMD.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable. Ground truth as typically understood for SaMD performance studies is not relevant here. The ground for "equivalence" is based on established performance and safety profiles of the predicate device.

8. The sample size for the training set:
Not applicable. This device is a physical dental implant, not an AI/SaMD.

9. How the ground truth for the training set was established:
Not applicable. This device is a physical dental implant, not an AI/SaMD.

In summary, this document demonstrates substantial equivalence of a physical dental implant to a legally marketed predicate device based on similarities in design, materials, and intended use, rather than through a novel performance study proving it meets specific acceptance criteria typically associated with SaMD or other complex medical devices requiring such studies.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 16, 2019

Hiossen, Inc. Peter Lee QA/RA Manager 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030

Re: K191751

Trade/Device Name: EM Provisional Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: September 16, 2019 Received: September 17, 2019

Dear Peter 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.

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

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 Part 803) for devices or post marketing 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 mediation-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.

for

Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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

Image /page/2/Picture/0 description: The image shows the logo for Hiossen Implant. The word "Hiossen" is written in a stylized font, with the "H" in red and the rest of the letters in gray. There is a red swoosh above the "H". Below the word "Hiossen" is the word "Implant" in smaller, gray letters.

85 Ben Fairless Drive airless Hills, PA 19030 888-768-0001 www.hiossen.com

Section 5 Indication for Use Statement - 1 PAGE

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

Device Name EM Provisional

Indications for Use (Describe)

Type of use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Service (301) 443-6740 EF

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

Image /page/3/Picture/0 description: The image is a logo for Hiossen Implant. The word "Hiossen" is written in a combination of red and gray letters. The word "Implant" is written in gray letters below the word "Hiossen."

5 Ben Fairless Drive Hills, PA 19030 www.hiossen.com

Section 6 510(k) Summary - 4 PAGES

(1) Submitter Information:
----------------------------	--

Submitted by:	Hiossen, Inc.85 Ben Fairless DriveFairless Hills, PA 19030
Contact Person:Telephone Number:Fax Number:	Peter Lee267-759-7031267-759-7031
Date Prepared:	November 8, 2019
(2) Device Name:· Proprietary Name:• Classification Name:• CFR Number:• Device Class:• Product Code:	EM ProvisionalImplant, Endosseous, Root-form872.3640Class IIDZE

(3) Predicate Device:

Device	510(k)	Manufacturer
MS System (Provisional)	K072871	OSSTEM Co., Ltd.
Hiossen Implant System*	K140934	Hiossen, Inc.

*Reference device

(4) Description of Device:

The EM Provisional is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. It is substantially equivalent in design, function and intended use to the MS System (Provisional), OSSTEM Implant Co., Ltd, K072871

Device	Diameter(mm)	Thread Length(mm)
EM Provisional	Ø1.8, Ø2.5	10.0, 13.0, 15.0

(5) Indication For Use:

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

Image /page/4/Picture/0 description: The image is a logo for Hiossen Implant. The word "Hiossen" is written in a combination of red and gray letters. The "H" and the top part of the "i" are red, while the rest of the letters are gray. Below the word "Hiossen" is the word "Implant" in smaller, gray letters.

85 Ben Fairless Drive Fairless Hills, PA 19030 888-768-0001 www.hiossen.com

(6) Substantial Equivalence:

The information and date provided in this submission established the EM Provisional is substantially equivalent to the primary predicate device, OSSTEM MS System (Provisional) in (510(k) number K072871).

	Proposed DeviceEM Provisional	Predicate DeviceMS System (Provisional)	Reference DeviceHIOSSEN IMPLANTSYSTEM
Device	EM Provisional	MS System (Provisional)	HIOSSEN IMPLANTSYSTEM
Manufacturer	Hiossen, Inc.	Osstem Co., Ltd.	Hiossen, Inc.
510(K) No.	New device	K072871	K140934
Design	Image: EM Provisional Design	Image: MS System (Provisional) Design	Image: HIOSSEN IMPLANT SYSTEM Design
Intended use	The EM Provisional isintended to be loadedimmediately in partially orfully edentulous mandiblesand maxilla to serve astemporary support forprovisional prostheticdevice during the healingphase of permanentendosseous dentalimplant(s).	The MS system(Provisional) is intended tobe loaded immediately inpartially or fully edentulousmandibles and maxilla toserve as temporarysupport for provisionalprosthetic device duringthe healing phase ofpermanent endosseousdental implants.	The HIOSSEN ImplantSystem is indicated foruse in partially or fullyedentulous mandibles andmaxillae, in support ofsingle or multiple-unitrestorations including;cemented retained, screwretained, or overdenturerestorations, and final ortemporary abutmentsupport for fixedbridgework. It is intendedfor delayed loading. Ultrawide Fixture System isintended to be used in themolar region.
Structure	• Screw form• One piece fixture andabutment	• Screw form• One-piece of Fixture andAbutment	• Internal Hex-connected• Submerged Fixture• Tapered body shape &Straight body shape
Diameters	1.8, 2.5	1.8, 2.5	3.5~6.8
Lengths	10.0, 13.0, 15.0	10.0, 13.0, 15.0	6.2~18.2
Material	Titanium alloy Ti-6Al-4V(ASTM F 136)	Titanium alloy Ti-6Al-4V(ASTM F 136)	Pure Titanium Grade 4(ASTM F67)
Surface	Machined finished	Machined finished	- SA(Sandblasted andAcid etched)
Sterilization	Radiation Sterile	Radiation Sterile	Radiation Sterile
Packaging	Secured in plastic ampule,housed in Tyvek-liddedblister tray, placed in atamper-evident outerpackage.	Secured in plastic ampule,housed in Tyvek-liddedblister tray, placed in aouter box	Secured in plastic ampule,housed in Tyvek-liddedblister tray, placed in atamper-evident outerpackage.

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

Image /page/5/Picture/0 description: The image shows the logo for Hiossen Implant. The logo is composed of the letters "HI" in red, followed by "OSSEN" in gray. The word "IMPLANT" is written in smaller gray letters below the word "OSSEN". There is a registered trademark symbol next to the word "OSSEN".

S.E.	The proposed device is substantially equivalent with respect to the intended use, structure, material, surface, sterilization and design with the legally marketed predicate device as well as the sterilization and packaging of the legally marketed reference device. The proposed device does not pose any new or increased risks as compared to the legally marketed predicate and reference devices.
------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Substantial Equivalence Conclusion

In accordance with the Federal Food Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification, HIOSSEN, INC. concludes since the EM Provisional has the same design, intended use, structure, diameters, lengths, material, surface, sterilization as the predicate device, MS System (Provisional) (K072871) and same sterilization and packaging to the reference Hiossen Implant System (K140934) it is substantially equivalent. The propose device does not pose any new or increased risk as compared to both the legally marketed predicate and reference devices.

Non-Clinical Performance Data

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence include data from the following tests:

Biocompatibility Testing

The EM Provisional is manufactured using the same manufacturing process and same well known and well established material as the predicate device, the MS System (Provisional), K072871, therefore we reason it was not necessary to re-test biocompatibility in order to support the biological safety of the EM Provisional.

Sterilization Validation

The EM Provisional (manufactured using the same manufacturing process, material and utilizes the same sterilize barrier system) is gamma irradiated under the same conditions and process as the predicate device, the MS System (Provisional), K072871, therefore we reason it was not necessary to re-test validation in order to support the sterilization validity of the EM Provisional.

Surface Treatment Characterization Testing

The EM Provisional surface is manufactured using the same manufacturing process, material and is its surface is machined finished just as the predicate device, the MS System (Provisional), K072871, therefore no additional character testing was necessary to support the equivalency of the EM Provisional.

Fatique Testing

The EM Provisional is manufactured using the same manufacturing process, material and same design, as the predicate MS System (Provisional), K072871. We reason based on the least burdensome principle that it was not necessary to re-test fatigue on the proposed device since both are the same device.

Compressive Strength Testing

The EM Provisional is manufactured using the same manufacturing process, material and same design, as the predicate MS System (Provisional), K072871. We reason based on the least burdensome principle that it was not necessary to re-test compressive strength on the proposed device since both are the same device.

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

Image /page/6/Picture/0 description: The image shows the logo for Hiossen Implant. The word "Hiossen" is written in a combination of red and gray letters, with the "H" and the top part of the "i" in red, and the rest of the letters in gray. Below the word "Hiossen" is the word "IMPLANT" in gray, with a large amount of space between each letter.

85 Ben Fairless Drive Fairless Hills, PA 19030 888-768-0001 www.hiossen.com

Pull-out Testing The EM Provisional is manufactured using the same manufacturing process, material and same design, as the predicate MS System (Provisional), K072871. We reason based on the least burdensome principle that it was not necessary to re-test pull-out on the proposed device since both are the same device.

Clinical Performance Testing

No clinical performance report(s) is being submitted.

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.