The HAPTITE Coating Implant System is 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. This system is dedicated for one and two stage surgical procedures and not dedicated for immediate loading. This system is intended for delayed loading.

Device Description

This product is the operating, dental material as placed dental implant to inner part of maxillary to sustain, maintain prosthetic repair tooth or denture, mainbody (structure of subpart) is made by Titanium (Grade 4), is treated as blasting powder, and RBM at room temperature of CaP type to reduce Bone loss to bottom 1mm of the Machine Collar. Also, screw part of below 1 mm is treated as SHS (Super High Speed) RBM HA (Hydroxyapatite) Coating at room temperature. It is connected to structure of upper part as the type of the internal. HA Thin film coating achieved through the process in which the HA particles impact on the surface of implant with high speed. By passing carrier gas, which comes from nitrogen tank, through the hopper containing HA particles, the HA particle and carrier gas can flow to the vacuum chamber. The vacuum chamber maintaining low pressure thanks to the vacuum pump, enable to spray the HA particles with carrier gas out in high speed(more than 500m/sec) through spray nozzle. As HA particles impact on the surface of implant, it reduced to fragment and those fragment make up thin film coating layer. The implant diameters are 3.7, 4.1, 4.3, 4.8, 5.5, 6.0, 6.5, and 7.0 mm and the implant lengths are 7, 8, 9, 10, 12, 14, and 16mm in this system. The system consists of 2 fixture systems, i-clean fixture and s-clean fixture, and 2 abutment systems i-clean and s-clean abutment. The i-clean abutment system is composed of healing cap, various abutments (solid, excellent solid, octa, synocta, inocta, temporary, healing, o-ring and free), screws (cover screw, closing screw, abutment screw, cvlinder screw), gold UCLA, gold cylinder. The s-clean abutment system is composed of healing cap, various abutments (sole, couple, hex, temporary, o-ring, free, octa, zero margin, freemill, and MOA), and gold cylinder, and various screws (abutment, cylinder). i-Clean Fixture is Non-submerged type, once surgery and safe structure as having 8° from center of connection part. s-Clean Fixture is Submerged type, twice surgery and safe structure as having 11° from center of connection part. The abutment lengths are 7, 8, 9, 10, 11, 12mm, and cuff lengths 0.5, 1, 1.5, 2, 2.5, 3, 3.5. 4. 4.5. 5.5. 7mm. The i-Clean fixture is available with either tapered, straight, or SAVE body designs. The i-Clean tapered fixture is available in diameters of 3.7, 4.1, 4.3, and 4.7mm and each diameter is available in lengths of 8, 10, 12, or 14mm. The i-Clean straight fixture is available in diameters of 4.05, 4.25, and 4.75mm and each diameter is available in lengths of 8, 10, 12, 14, and 16mm. The i-Clean SAVE fixture is available in diameters of 5.5, 6.0, 6.5, and 7.0mm and each diameter is available in lengths of 7, 8, 9, 10, and 12mm. The i-Clean Tapered II design contains a thread design with differs from the i-Clean Tapered fixture design. The i-Clean Tapered II has no 'micro thread' design. The s-Clean fixture is available with either tapered, straight, or SAVE body designs. The s-Clean tapered fixture is available in diameters of 3.7, 4.1, 4.3, and 4.8mm and each diameter is available in lengths of 8, 10, 12, or 14mm. The s-Clean straight fixture is available in diameters of 4.1, 4.3, and 4.75mm and each diameter is available in lengths of 8, 10, 12, 14, and 16mm. The s-Clean SAVE fixture is available in diameters of 5.5. 6.0. 6.5. and 7.0mm and each diameter is available in lengths of 7, 8, 9, 10, and 12mm. The s-Clean Tapered II design contains a thread design with differs from the s-Clean Tapered fixture design. The s-Clean Tapered II has no 'micro thread' design.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the HAPTITE Coating Implant System, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than setting novel acceptance criteria for a new device type. Therefore, direct "acceptance criteria" for performance are not explicitly stated as they would be for a truly novel device. Instead, the document compares the subject device's performance against the established performance of its predicate devices to demonstrate equivalence. The "acceptance criteria" are implied to be achieving performance comparable to or exceeding the predicate devices in the listed tests.

Acceptance Criteria (Implied by Predicate Performance)	Reported Device Performance (HAPTITE Coating Implant System)
Mechanical Strength (Shear bonding strength)	$\approx$ 37 MPa (compared to predicate's 13 MPa and standard 34.5 MPa)
Mechanical Strength (Tensile bonding strength)	$\approx$ 41 MPa (compared to standard 34.5 MPa)
Coating Stability (HA Coating Implant Graft Test)	Successfully performed in pig bone
Dimensional Accuracy (Gap between fixture and abutment)	Successfully performed
Rotational Accuracy (Rotational angle tests)	Successfully performed
Surface Characteristics (Roughness, Crystallinity, Porosity, Cross-section, Density, Surface area, CaP ratio)	Successfully performed tests
Biocompatibility (Material)	CP. GR.4 ASTM F67 (Identical to predicate)
Sterilization Method	Gamma sterilized (Identical to predicate)

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

Sample Size:
- The document does not explicitly state the sample sizes used for each test (e.g., how many implants were tested for shear strength, how many pig bones were used, etc.). This information is typically found in the full test reports, not always in the 510(k) summary.
Data Provenance:
- The tests were described as "Non-clinical Testing data" and performed by Dentis Co., Ltd. (the manufacturer).
- Country of Origin: South Korea (where Dentis Co., Ltd. is located).
- Retrospective or Prospective: These are laboratory tests and animal models, which are inherently prospective in their design to evaluate specific device properties.

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

This information is not applicable to the type of non-clinical, laboratory, and animal model testing described. These tests rely on standardized methods (e.g., ASTM standards) and direct measurements, not expert consensus for "ground truth" in the way clinical studies or diagnostic AI algorithms do. Therefore, no experts were used to establish ground truth in this context.

4. Adjudication Method for the Test Set

Not applicable. As these are objective, non-clinical tests (e.g., measuring shear strength, evaluating coating uniformity), there is no "adjudication" in the sense of reconciling differing expert opinions. The results are quantitative measurements or direct observations against a standard.

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

No, an MRMC comparative effectiveness study was not done. The device in question is an endosseous dental implant, which is a physical medical device, not a diagnostic imaging AI algorithm that would typically be evaluated with MRMC studies or human-in-the-loop performance studies. The evaluation focuses on the physical and material properties of the implant itself.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. As stated above, this is a physical medical device, not an algorithm. Therefore, "standalone" performance for an algorithm is not relevant here.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests was based on objective measurements, adherence to ASTM standards, and direct observation of physical and material properties. For example:
- Shear and tensile strength: Measured values against established ASTM standards (ASTM F1147, 1044).
- Coating stability: Evaluation of the coating layer after an in-vivo graft test in pig bone.
- Surface characteristics: Objective measurements and analyses of roughness, crystallinity, porosity, etc.

8. Sample Size for the Training Set

Not applicable. Again, this is a physical medical device, not an AI algorithm that requires a "training set."

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

Not applicable. See point 8.

Summary

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K111364

510(K) Summary

Submitter

Dentis Co., Ltd. Jung Seob Guem #951, Woram-dong, Dalseo-Gu Daegu citv South Korea Phone: +82-53-583-2804 Fax: +82-53-583-2806

Official Correspondent Kodent Inc. April Lee 325 N. Puente st. Unit B Brea, CA 92821 Email: kodentinc@gmail.com Phone: 714-525-0114 Fax: 714-525-01116

Device Information

Trade Name: HAPTITE Coating Implant System Common Name: Endosseous Dental Implant Classification Name: Implant, Endosseous, Root-Form Product Code: DZE Regulation Number: 872.3640 Device Class: Class II Date Prepared: 2011-5-11

General Description

HA Thin film coating achieved through the process in which the HA particles impact on the surface of implant with high speed.

By passing carrier gas, which comes from nitrogen tank, through the hopper containing HA particles, the HA particle and carrier gas can flow to the vacuum chamber. The vacuum chamber maintaining low pressure thanks to the vacuum pump, enable to spray the HA particles with carrier gas out in high speed(more than 500m/sec) through spray nozzle. As HA particles impact on the surface of implant, it reduced to fragment and those fragment make up thin film coating layer.

The implant diameters are 3.7, 4.1, 4.3, 4.8, 5.5, 6.0, 6.5, and 7.0 mm and the implant lengths are 7, 8, 9, 10, 12, 14, and 16mm in this system.

The system consists of 2 fixture systems, i-clean fixture and s-clean fixture, and 2 abutment systems i-clean and s-clean abutment.

The i-clean abutment system is composed of healing cap, various abutments (solid, excellent solid, octa, synocta, inocta, temporary, healing, o-ring and free), screws (cover screw,

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closing screw, abutment screw, cvlinder screw), gold UCLA, gold cylinder ..

The s-clean abutment system is composed of healing cap, various abutments (sole, couple, hex, temporary, o-ring, free, octa, zero margin, freemill, and MOA), and gold cylinder, and various screws (abutment, cylinder).

i-Clean Fixture is Non-submerged type, once surgery and safe structure as having 8° from center of connection part.

s-Clean Fixture is Submerged type, twice surgery and safe structure as having 11° from center of connection part.

The abutment lengths are 7, 8, 9, 10, 11, 12mm, and cuff lengths 0.5, 1, 1.5, 2, 2.5, 3, 3.5. 4. 4.5. 5.5. 7mm.

The i-Clean fixture is available with either tapered, straight, or SAVE body designs. The i-Clean tapered fixture is available in diameters of 3.7, 4.1, 4.3, and 4.7mm and each diameter is available in lengths of 8, 10, 12, or 14mm. The i-Clean straight fixture is available in diameters of 4.05, 4.25, and 4.75mm and each diameter is available in lengths of 8, 10, 12, 14, and 16mm. The i-Clean SAVE fixture is available in diameters of 5.5, 6.0, 6.5, and 7.0mm and each diameter is available in lengths of 7, 8, 9, 10, and 12mm. The i-Clean Tapered II design contains a thread design with differs from the i-Clean Tapered fixture design. The i-Clean Tapered II has no 'micro thread' design.

The s-Clean fixture is available with either tapered, straight, or SAVE body designs. The s-Clean tapered fixture is available in diameters of 3.7, 4.1, 4.3, and 4.8mm and each diameter is available in lengths of 8, 10, 12, or 14mm. The s-Clean straight fixture is available in diameters of 4.1, 4.3, and 4.75mm and each diameter is available in lengths of 8, 10, 12, 14, and 16mm. The s-Clean SAVE fixture is available in diameters of 5.5. 6.0. 6.5. and 7.0mm and each diameter is available in lengths of 7, 8, 9, 10, and 12mm. The s-Clean Tapered II design contains a thread design with differs from the s-Clean Tapered fixture design. The s-Clean Tapered II has no 'micro thread' design.

Indication for Use

The Dentis Implant System is 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. This system is dedicated for one and two stage surgical procedures and not dedicated for immediate loading. This system is intended for delayed loading.

Predicate Devices & Comparison

The subject device is substantially equivalent to the following predicate device:

DIO BIOTITE-H IMPLANT SYSTEM manufacture by DIO Deparment, DSI (K073070) .
Replace HA coated implant manufactured by Nobel Biocare USA, INC. (K022424) .

Testing and other comparisons have established that the subject of HAPTITE implant system is substantially equivalent in design, materials, indications and intended use, packaging, labeling, and performance to the predicate device currently marketed in the U.S.

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	Subject device	Predicate device
Devicename	Dentis HAPTITEImplant system	DentisImplantSystem	DIO BIOTITE-HIMPLANT SYSTEM	Replace HA CoatedImplant
510(k)number	N/A	K082843/K073486	K073070	K022424
Manufacturer	Dentis Co., Ltd.	DentisCo., Ltd.	DIO Department, DSI,Inc.	Nobel Biocare USA, Inc.
Intendeduse	ldentical topredicate devices	ldenticaltopredicatedevices	The implants areindicated for surgicalplacement in theupper or lower jaw toprovide a means forprosthetic attachmentin single toothrestoration and inpartially or fullyedentulous spans withmultiple single teeth,or as a terminal orintermediary abutmentfor fixed or removablebridgework, and toretain overdentures.	The implants are indicatedfor surgical placement inthe upper or lower jaw toprovide a means forprosthetic attachment insingle tooth restoration andin partially or fullyedentulous spans withmultiple single teeth, or asa terminal or intermediaryabutment for fixed orremovable bridgework, andto retain overdentures.
Material	CP. GR.4ASTM F67	CP. GR.4ASTMF67	CP. GR.3 and GR.4ASTM F67	CP. GR.3 and GR.4ASTM F67
Design	Tapered andstraight	Taperedandstraight	Tapered	Straight
Implantdiameter	3.7, 4.1, 4.3, 4.8,5.5, 6.0, 6.5 and7.0mm	3.5, 3.7,4.1, 4.3,4.8, 5.1,5.5, 6.0,6.5 and7.0mm	3.8, 4.1, 4.5, 4.8, and5.3mm	3.5, 4.3, 5.0, 6.0mm
Implantlength	7, 8, 9, 10, 12, 14and 16mm	7, 8, 10,12 and14mm	8-14mm	10,13,16mm
Attachments	Various abutmentsand components	Variousabutments andcomponents	Various abutmentsand components	Various abutments andcomponents
Surfacetreatment	HA coating	RBM	HA coating	HA coating
Coatingmethod	Super High SpeedBlast CoatingProcess	NonCoating	Electrochemical1	Plasma-sprayed HAcoating2
Coatingthicknesss	1~2µm	15±5µm1	>5µm2
Solubility	insoluble	Soluble1	Insoluble2
Surfacechemistry	100% crystallineHA	95% Brushite + 5%hydroxyapatite1	Amorphous + crystallineHA2
Shearstrength	$ \approx $ 37MPa	13MPa1	$ \approx $ 37.4MPa
Morphology	Image: Morphology 1	Image: Morphology 2	Image: Morphology 3
Gammasterilized	Yes	Yes	Yes
ProductCode	DZE	DZE	DZE

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Non-clinical Testing data

Measurement of the gap between fixture and abutment, rotational angle tests were successfully performed.
Shear bonding strength test was successfully performed in accordance with ASTM F . 1147, 1044 as the result about 37 MPa over standard 34.5 MPa.
Tensile bonding strength test was successfully performed in accordance with ASTM F -1147, 1044 as the result about 41 MPa over standard 34.5 MPa.
-HA Coating Implant Graft Test in the pig bone for the evaluation of the stability of the coating layer was successfully performed.
Roughness, Degree of crystallinity, Porosity, Cross section analysis, Density, Surface . area analysis, CaP ratio tests were successfully performed.

Conclusion

The HAPTITE Coating Implant System, subject of this submission, constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. The risks of using the device as recommended pose no greater risks than other implant systems. This system has the same intended use and fundamental scientific technology as its predicate devices. HAPTITE Implant system, as designed and manufactured, is as safe and effective as the predicate devices and therefore is believed to be substantially equivalent to Predicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the logo. The logo is black and white.

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

Dentis Company, Limited Ms. April Lee Consultant Kodent Incorporated 325 N. Puente Street, Unit B Brea, California 92821

FEB - 1 2012

Re: K111364

Trade/Device Name: HAPTITE Coating Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: January 30, 2012 Received: January 30, 2012

Dear Ms. 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. 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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Page 2 - Ms. Lee

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. 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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Indication for Use

510(K) Number (if known):

K111364

HAPTITE Coating Implant System Device Name:

The HAPTITE Coating Implant System is 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 This system is dedicated for one and two stage surgical procedures and not dedicated bridgework. for immediate loading. This system is intended for delayed loading

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter (Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1

Swer Rose

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

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.