An endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple unit prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional 2 stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Patients must be subject for dental treatment with endosseous implants.

Device Description

The Biomate Dental Implant System consists of Bone Type Implant Plus, Shaping Abutment and Healing Abutment. The Biomate Dental Implant System is made of commercial pure titanium (ASTM F67, Grade 4). Threaded dental implants are with Precision Dimension Laser (PDLTM) surface treatment, while Shaping Abutment and Healing Abutment are with TiN coated surface treatment. The device is designed for conventional two-stage and single stage procedures for single and multiple unit prosthetics. It is intended to replace missing teeth.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device (Biomate Dental Implant System). This type of document focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing. It does not describe a study involving an AI algorithm or human reader performance. Therefore, I cannot provide information on acceptance criteria and studies related to AI performance from this document.

The document discusses traditional medical device validation through non-clinical performance tests, and states that "There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device."

To answer your request, I would need a document describing a study for an AI-powered medical device.

Summary

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Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 26, 2018

Biomate Medical Devices Technology Co., Ltd. Leslie Su Assistant Manager 1F., No.59, Luke 2nd Road, Luzhu District Kaohsiung City, 820 TAIWAN (R.O.C)

Re: K170732

Trade/Device Name: Biomate Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: September 21, 2018 Received: September 28, 2018

Dear Leslie Su:

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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Andrew I. Steen -S

Tina Kiang, Ph.D. for Acting 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) K170732

Device Name Biomate Dental Implant System

Indications for Use (Describe)

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)

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Biomate Dental Implant System

K170732

1. Date Prepared

2018-10-26

2. Submitter's Information

Company Name:	Biomate Medical Devices Technology Co., Ltd.
Company Address:	1F., No.59, Luke 2nd Rd., Luzhu Dist,Kaohsiung City, 820,Taiwan, R. O. C
Contact Person:	Leslie Su
Phone:	+886-7-952-5999, ext. 881
Fax:	+886-7-621-3163
Email:	leslie.su@shanyin.com.tw

3. Trade Name, Common Name, Classification

Trade or Proprietary Name:	Biomate Dental Implant System
Common Name:	Implant, Endosseous Root-Form
Subsequent Common Name:	Abutment, Implant, Dental, Endosseous
Classification Name:	Endosseous dental implant
Subsequent Classification Name:	Endosseous dental implant abutment
Regulation Number:	21 CFR 872.3640
Product Code:	DZE
Subsequent Product Code	NHA
Class of Device:	Class II
Panel:	Dental

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4. Legally Marketed Predicate Device(s)

4.1 Primary Predicate

510(k) Number:	K142174
Applicant:	BIOMATE MEDICAL DEVICES TECHNOLOGY CO., LTD.
Device Name:	BIOMATE DENTAL IMPLANT SYSTEM

4.2 Reference Predicate

510(k) Number:	K171694
Applicant:	Dentis Co., Ltd.
Device Name:	s-Clean TiN Abutments

5. Device Description

6. Indication for Use Statement

7. Technological Characteristics

The Biomate Dental Implant System consists of Bone Type Implant Plus, Shaping Abutment and Healing Abutment. The device is made of commercial pure titanium (ASTM F67, Grade 4).

Bone Type Implant Plus comes with PDL™ surface treatment and consists a set of threaded, » root-form, bone level implants offered in 3.5, 4.0, 4.5mm diameters (D) with 8, 10, 12, 14mm length (L).

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»Shaping Abutment comes with TiN coated surface treatment via Physical Vapor Deposition (PVD) process and consists a set of abutments offered in 4.0, 5.0, 6.0mm diameters (D) with 11.0mm height (H), and 1.5, 3.0 mm Gingival Height (G/H)
» Healing Abutment comes with TiN coated surface treatment via Physical Vapor Deposition (PVD) process and consists a set of abutments offered in 4.0, 4.5, 5.0, 6.0mm diameters (D) with 2.0, 3.0, 5.0, 7.0mm height (H), and 1.0, 2.0, 3.0 mm Gingival Height (G/H)

The subject device is compatible with our previous cleared device submission (K142174). The subject device is provided sterile (Radiation) and for single use only.

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8. Substantial Equivalence

The following table compares the Biomate Dental Implant System to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. Comparative data is shown in Table 5-1.

	Subject device	Primary Predicate	Reference predicate
Manufacturer	Biomate Medical DevicesTechnology Co., Ltd.	Biomate Medical DevicesTechnology Co., Ltd.	Dentis Co., Ltd
Device Name	Biomate Dental Implant System	Biomate Dental Implant System	s-Clean TiN Abutments
510(k)Number	K170732	K142174	K171694
Product Code	DZE	DZE	NHA
RegulationNumber	872.3640	872.3640	872.3630
RegulationName	Endosseous dental implant	Endosseous dental implant	Endosseous dental implantabutment
Prescriptionuse	YES	YES	YES
Indicationsfor Use	An endosseous dental implant isindicated for surgical placementin the upper and lower jaw arches,to provide a root form means forsingle or multiple unit prostheticappliance attachment to restore apatient's chewing function.Implants can be placed with aconventional 2 stage surgicalprocess with an option fortransmucosal healing or they canbe placed in a single stagesurgical process for immediateloading. It is intended forimmediate loading when goodprimary stability is achieved andwith appropriate occlusal loading.Patients must be subject for dentaltreatment with endosseousimplants.	An endosseous dental implant isindicated for surgical placement inthe upper and lower jaw arches, toprovide a root form means forsingle or multiple unit prostheticappliance attachment to restore apatient's chewing function.Implants can be placed with aconventional 2 stage surgicalprocess with an option fortransmucosal healing or they canbe placed in a single stage surgicalprocess for immediate loading. Itis intended for immediate loadingwhen good primary stability isachieved and with appropriateocclusal loading. Patients must besubject for dental treatment withendosseous implants.	The s-Clean TiN CoatingAbutments is an endosseousdental implant that isindicated for surgicalplacement in the upper andlower jaw arches, to providea root form means for singleor multiple-units prostheticappliance attachment torestore a patient's chewingfunction. Implants can beplace with a conventionaltwo stage surgical processwith an option fortransmucosal healing or theycan be placed in a singlestage surgical process forimmediate loading whengood primary stability hasbeen achieved and withappropriate occlusal loading.
ConsistedInstrument	Dental Implants, Abutments	Dental Implants, Abutments,screws	Abutments
Sterilization	Gamma irradiation	Gamma irradiation	Non-sterile
ImplantMaterial	Grade 4 Pure Titanium per ASTMF67	Grade 4 Pure Titanium per ASTMF67	Not applicable
Implant Type	Threaded, Root-form, Bone level	Threaded, Root-form, Bone level	Not applicable
Implant toAbutmentConnection	Internal Hex	Internal Hex	Not applicable
ImplantDiameter(mm)	3.5, 4.0, 4.5	3.3, 4.1, 4.8, 5.5	Not applicable
ImplantLength (mm)	8, 10, 12, 14	8, 10, 12, 14	Not applicable
ImplantSurfaceTreatment	PDLTM surface treatment	PDLTM surface treatment	Not applicable
AbutmentSystem	Healing Abutment, ShapingAbutment	Healing Abutment, SolidAbutment, Simple Abutment, 15°/25° Angled Abutment, TemporaryAbutment, Ball Abutment	s-Clean TiN Half CoatingFreeMill Abutment
AbutmentMaterial	Grade 4 Pure Titanium per ASTMF67	Grade 4 Pure Titanium per ASTMF67	Pure Titanium (Grade 4)
AbutmentAngle (°)	0	0, 15, 25	Not available
PlatformDiameter(mm)	4.0, 4.5, 5.0, 6.0	4.0, 4.5, 5.0, 6.0	4.0, 4.5, 5.5, 6.5, 7.5
PlatformLength (mm)	2.0, 3.0, 5.0, 7.0	3.0, 5.0, 7.0	1.3, 1.8, 2.8, 3.8
PlatformGingivalHeight (mm)	1.0, 1.5, 2.0, 3.0	0.5,1.0, 2.0, 3.0 ,4.0	Not available
AbutmentSurfaceTreatment	TiN coated surface treatment	N/A	TiN coating by physicalvapor deposition (PVD)

Table 2-1 Substantial Equivalence Comparison

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9. Summary of Non-clinical Tests

Biomate Dental Implant System and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, we completed a number of non-clinical performance tests. The Biomate Dental Implant System meets all the requirements for overall design, sterilization, biocompatibility, electrical safety results and the recommendations in "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant

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Abutments" confirming that the design output meets the design inputs and specifications for the device.

The Biomate Dental Implant System passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:

Biocompatibility Testing referenced in K142174 per ISO 10993-1, ISO 10993-3, ISO 10993-5, » ISO 10993-6, ISO 10993-10, ISO 10993-11, ISO 10993-12
Sterilization testing referenced in K142174 per ISO 11137-1, ISO 11137-2, ISO 11737-1, ISO » 11737-2
Fatigue testing referenced in K142174 per ISO 14801 »
Shelf-Life testing referenced in K142174 per ISO 11607 »
LAL testing according to United States Pharmacopeial Convention, Inc. USP <85> »

10. Clinical Tests

There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device.- The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

11. Conclusion

The Biomate Dental Implant System as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device.

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.