The Dentis Dental Implant System is 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-units prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible based on four splinted interforminal placed implants.

Device Description

An endosseous dental implant is a device made of Pure Titanium Grade 4. Dentis Dental Implant system has been designed to accommodate the following dental implant restoration protocols; Immediate or Early loading, immediate placement or one or two stage placement. Dentis Dental Implant systems help patients who have partial or whole teeth loss mastication to chew as dental implant. The surface of the system has been treated with RBM (Resorbable Blasted media). The fixture diameters are 3.7, 4.1, 4.3, 4.8mm and lengths are 7, 8, 10, 12, 14 mm in this system. The contained various abutments in the system are click bridge, cover screw, gold cylinder, solid abutment, couple abutment, angled abutment, healing cap, abutment screw, retaining screw, temporary cylinder, CCM cylinder, and connector. The rage of the abutment diameters is 1.96 mm to 7.4mm and range of abutment lengths is 3.7mm to 14.25mm. The Connector, MU (Solid, couple, angled, abutment screw), MU Healing cap, and MU Retaining Screw are made of Ti-6Al-4V ELI. The MU click bridge body and MU Temporary Cylinder are made of Titanium Grade 4. The MU Click Bridge Cap is made of PEEK. The MU Gold Cylinder (Body) is made of Gold Alloy. The MU Gold Cylinder (Plastic Sleeve) and MU CCM Cylinder (Plastic Sleeve) are made of Acetal. The MU CCM Cylinder (Body) is made of Co-Cr-Mo alloy. The possible angulation range of angled abutments is 17 to 30 degrees. The Fixtures are supplied sterile and the abutments are provided non-sterile. The abutments should be sterilized before use.

AI/ML Overview

The provided text (K150344) describes the Dentis Dental Implant System. Here's an analysis of the acceptance criteria and supporting studies based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (from "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant abutments")	Reported Device Performance (Dentis Dental Implant System)
Fatigue Testing	In accordance with ISO 14801:2007 under the worst-case scenario.	Performed in accordance with ISO 14801:2007 under the worst-case scenario.
Sterilization Validation	In accordance with ISO 11137-1:2006, ISO 11137-2:2006.	Performed in accordance with ISO 11137-1:2006, ISO 11137-2:2006.
Biocompatibility Evaluation	Not explicitly stated, but generally involves comparison with established biocompatible materials.	Biocompatibility evaluation performed by comparing materials and manufacturing process with the predicate device.
Surface Treatment Analysis	Not explicitly stated, but generally involves characterization of the treated surface.	Surface treatment analysis was used to support the decision of substantial equivalence.
Material Composition	The predicate device materials (Commercially pure titanium GR.3 and GR.4 (ASTM-F-67), Ti-6Al-4V ELI, Gold Alloy, Acetal) serve as a benchmark.	Subject device materials are Commercially pure titanium GR.4 (ASTM-F-67) for dental implants and Titanium alloy (Ti-6Al-4V ELI) for abutments, matching or being similar to the predicate. Other materials like PEEK, Co-Cr-Mo alloy are also listed for specific components.
Intended Use	The predicate device's intended use serves as a benchmark for substantial equivalence.	Identical to predicate devices (for use in edentulous sites in the mandible or maxilla for support for various prosthetic restorations).
Design	Similar to predicate device (Morse Taper with Tread).	Morse Taper with Tread.
Fixture Diameter & Length	Predicate: Diameter 3.5, 3.7, 4.1, 4.3, 4.8, 5.5, 6.0mm; Length 7-14mm.	Subject: Diameter 3.7, 4.1, 4.3, 4.8mm; Length 7-14mm (with addition of 7mm and 14mm fixtures and various abutments).

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

The document describes non-clinical bench testing. Therefore, the concept of a "test set" in the context of clinical data or image-based AI evaluation (which usually refers to patient data) does not apply here. The "test set" for this device consists of physical implant components subjected to standardized engineering tests.

Sample Size for Physical Testing: Not explicitly stated. For bench testing, sample sizes are typically determined by relevant ISO standards (e.g., ISO 14801 for fatigue testing, which specifies a minimum of 5 samples per test group). The document only states that testing was "performed in accordance with ISO 14801" and "ISO 11137-1, 11137-2."
Data Provenance: The testing was non-clinical (bench testing), not derived from human or animal subjects. The data originated from the manufacturer's (Dentis Co., Ltd., based in South Korea) testing facilities or subcontracted laboratories specializing in medical device testing.

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

This question is not applicable to the type of data presented. "Ground truth" usually refers to a definitive diagnosis or finding established by human experts or pathology in clinical studies. For bench testing of physical devices, the "ground truth" is defined by the objective pass/fail criteria of the engineering standards themselves (e.g., whether a device withstands a certain load for a specified number of cycles without fracture). There are no human experts establishing a "ground truth" for the performance of the implant in the clinical sense mentioned here.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements between human readers/experts in clinical studies. For bench testing, the results are typically quantitative and objectively measured against pre-defined performance specifications of the standard.

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 dental implant system (a physical medical device), not an Artificial Intelligence (AI) diagnostic or assistive tool. Therefore, an MRMC study or an assessment of human reader improvement with AI assistance is entirely irrelevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. As noted above, this is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

For this specific device, the "ground truth" for its performance is established by objective engineering specifications and standardized test methods. For example:

Fatigue Testing: The "ground truth" is whether the implant system can withstand repetitive loading for a certain number of cycles without failure, as defined by ISO 14801:2007. The absence of fracture or significant deformation under specified conditions is the "truth."
Sterilization Validation: The "ground truth" is that the sterilization process achieves a predefined Sterility Assurance Level (SAL), as defined by ISO 11137-1:2006 and ISO 11137-2:2006.
Biocompatibility: The "ground truth" is that the materials used are non-toxic and do not elicit an adverse biological response, typically established by historical data on similar materials (predicate device) and compliance with relevant ISO 10993 standards (though not explicitly detailed beyond "comparing materials... with the predicate device").

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this traditional medical device submission. Training sets are used for machine learning models.

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

Not applicable. As there is no training set for a machine learning model, there is no ground truth established for it.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, one behind the other, with flowing lines representing hair or fabric.

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

July 24, 2015

Dentis Co., Ltd. % April Lee Consultant WithUS Consulting 2531 Pepperdale Drive Rowland Heights, California 91748

Re: K150344

Trade/Device Name: Dentis Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: June 22, 2015 Received: June 26, 2015

Dear April 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.

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

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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/ResourcesforYou/Industry/default.htm. 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 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,

Susan Runno DDS, MA

Erin 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

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Image /page/2/Picture/0 description: The image shows the word "DENTIS" in bold, black font. To the left of the word is an orange graphic that resembles a flame or a stylized letter "D". The graphic is a gradient, with the color transitioning from a lighter orange at the top to a darker orange at the bottom.

Dentis Co., Lt 99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea

Tel : 82.53.582.2804 / Fax : 82.53.583.2806

Indication for Use

K150344 510(K) Number (if known):

Device Name: Dentis Dental Implant System

Indication for Use:

Prescription Use

AND/OR

Over-The-Counter

(Part 21 CFR 801 Subpart D)

(Per 21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the word "DENTIS" in bold, black font. To the left of the word is an orange graphic that resembles a flame or a stylized letter 'D'. The graphic is a gradient, with the bottom being a darker orange and the top being a lighter orange.

Dentis Co., Ltd.

99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : 82.53.582.2804 / Fax : 82.53.583.2806

510(k) Summary

Submitter

Dentis Co., Ltd. Inyeong Lee 99, Seongseoseo-ro, Dalseo-gu Daegu Korea Email: iylee@dentis.co.kr Tel. +82-53-582-2804 Fax. +82-53-583-2806

Official Correspondent

WithUS Group, Inc. April Lee 2531 Pepperdale Drive, Rowland Heights, CA 91748 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122

Device Information

Trade Name: Dentis Dental Implant System
Common Name: Dental Implant System ●
Classification Name: Endosseous Dental Impant ●
Primary Product Code: DZE ●
Secondary Product Code: NHA
Panel: Dental
Regulation Number: 872.3640
Device Class: Class II
. Date prepared: 7/24/2015

General Description

s-Clean tapered fixture: . Ø 3.7mm (D) x 7 mm (L) / 14 mm (L) Ø 4.1mm (D) x 7 mm (L) / 8 mm (L) / 10 mm (L) / 12 mm (L) / 14 mm (L) Ø 4.3mm (D) x 7 mm (L) Ø 4.8mm (D) x 7 mm (L)
The contained various abutments in the system are click bridge, cover screw, gold cylinder, solid abutment, couple abutment, angled abutment, healing cap, abutment screw, retaining screw, temporary cylinder, CCM cylinder, and connector.

The rage of the abutment diameters is 1.96 mm to 7.4mm and range of abutment lengths is 3.7mm to 14.25mm. The Connector, MU (Solid, couple, angled, abutment screw), MU Healing cap, and MU Retaining Screw are made of Ti-6Al-4V ELI. The MU click bridge body and MU Temporary Cylinder are made of Titanium Grade 4. The MU Click Bridge Cap is made of PEEK. The MU Gold Cylinder (Body) is made of Gold Alloy. The MU Gold Cylinder (Plastic Sleeve) and MU CCM Cylinder (Plastic Sleeve) are made of Acetal. The MU CCM Cylinder (Body) is made of Co-Cr-Mo alloy.

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Dentis Co., Ltd.

99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : 82.53.582.2804 / Fax : 82.53.583.2806

The possible angulation range of angled abutments is 17 to 30 degrees.

Cover Screw ● Ø 3.6 mm (D) x 5.9 mm (L) . MU Click Bridge Body Ø 4.8 mm (D) x 5.5 mm (L) MU Click Bridge Cap ● Ø 4.6 mm (D) x 4.8 mm (L) . MU Gold Cylinder Ø 4.8 mm (D) x 14.25 mm (L) MU Solid Abutment ● Ø 4.8 mm (D) x 9.2 mm (L) / 10.2 mm (L) / 11.2 mm (L) / 12.2 mm (L) ● MU Couple Abutment 0 4.8 mm (D) x 4.34 mm (L) / 5.34 mm (L) / 6.34 mm (L) / 7.34 mm (L) . MU Angled Abutment Angle 17° - Ø 4.8 mm (D) x 6.08 mm (L) / 8.08 mm (L) Angle 30° - Ø 4.8 mm (D) x 6.69 mm (L) / 8.69 mm (L) ● MU Healing Cap Ø 5.4 mm (D) x 5.0 mm (L) . MU Abutment Screw (Couple) Ø 1.96 mm (D) x 9.2 mm (L) / 10.2 mm (L) / 11.2 mm (L) / 12.2 mm (L) . MU Abutment Screw (Angled) Ø 2.32 mm (D) x 7.8 mm (L) . MU Retaining Screw Ø 1.98 mm (D) x 3.7 mm (L) MU Temporary Cylinder ● Ø 4.8 mm (D) x 10.0 mm (L) MU CCM Cylinder ● Ø 4.8 mm (D) x 14.25 mm (L) ● Connector Ø 5.7 mm (D) x 6.7 mm (L) Ø 3.8 mm (D) x 6.8 mm (L) / 6.0 mm (L) Ø 4.5 mm (D) x 6.85 mm (L) / 6.0 mm (L) Ø 5.4 mm (D) x 6.85 mm (L) / 6.0 mm (L) Ø 4.0 mm (D) x 8.7 mm (L) / 8.0 mm (L) Ø 4.3 mm (D) x 8.7 mm (L) / 8.0 mm (L) Ø 3.8 mm (D) x 9.0 mm (L) / 7.45 mm (L) Ø 4.2 mm (D) x 10.1 mm (L) / 7.95 mm (L) Ø 5.3 mm (D) x 5.15 mm (L), Ø 4.8 mm (D) x 4.45 mm (L) Ø 7.4 mm (D) x 6.85 mm (L) / 5.0 mm (L) Ø 5.3 mm (D) x 6.4 mm (L) / 5.7 mm (L)
The Fixtures are supplied sterile and the abutments are provided non-sterile. The abutments should be sterilized before use.

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Dentis ( 99. Seongseoseo-ro, Dalseo-gu, Daemi Tel : 82.53.582.2804 / Fax : 82.53.583.2806

Image /page/5/Picture/1 description: The image shows the logo for DENTIS. The logo consists of an orange abstract shape on the left and the word "DENTIS" in black, bold letters on the right. The abstract shape appears to be a stylized flame or a curved shape with a circle at the top.

Indication for Use

Materials:

The devices are fabricated from CP Titanium (Grade 4) that conforms to ASTM F67 for Dental Implant and Titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136 for Abutments.

Performance Data (Bench Testing):

Non-clinical tests followed the recommendations in the "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant and Endosseous Dental Implant abutments". Fatigue Testing performed in accordance with ISO 14801:2007 under the worst case scenario, Sterilization Validation testing performed in accordance with ISO 11137-1:2006, ISO 11137-2:2006 and biocompatibility evaluation by comparing materials and manufacturing process with the predicate device, and surface treatment analysis were used to support the decision of substantial equivalence.

Predicate Devices:

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

K073486, Dentis Dental Implant System manufactured by Dentis Co., Ltd.

Comparison to Predicate Device:

Fixture

	Subject device	Predicate device
Device name	Dentis Dental Implant System	Dentis Dental Implant System
510(k) number	NA	K073486
Manufacturer	Dentis Co., Ltd.	Dentis Co., Ltd.
Intended use	Identical to predicate devices	DENTIS implant is designed for usein edentulous sites in the mandible ormaxilla for support for a completedenture prosthesis, terminal orintermediate abutment for fixed

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Image /page/6/Picture/0 description: The image shows the word "DENTIS" in bold, black letters. To the left of the word is an orange graphic that resembles a stylized flame or swirl. The text and graphic are the primary elements in the image.

9 - Dentis Co., Ltd.
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea
2806

		bridgework, partial dentures, or singletooth replacements.
Material	Commercially pure titanium GR.4(ASTM-F-67)	Commercially pure titanium GR.3 andGR.4 (ASTM-F-67)
Design	Morse Taper with Tread	Morse Taper with Tread
Fixture diameter	3.7, 4.1, 4.3, 4.8mm	3.5, 3.7, 4.1, 4.3, 4.8, 5.5, 6.0mm
Fixture length	7-14mm	7-14mm
Surface treatment	RBM	RBM
Gamma sterilized	Yes	Yes
Product Code	DZE	DZE

2) Abutment

	Subject device	Predicate device
510(k) number	NA	K073486
Product Name	Cover Screw	Cover Screw
Dimension	Ø 3.6 mm (D) x 5.9 mm (L)	Ø 3.4 mm (D) x 6.5 mm (L)
Material	CP Titanium Grade 4	Ti-6Al-4V ELI
Connection	Hex Type	Hex Type
Product Name	MU Click Bridge Body, Cap	N/A
Dimension	(Body) Ø 4.8 mm (D) x 5.5 mm (L)(Cap) Ø 4.6 mm (D) x 4.8 mm (L)	N/A
Material	(Body) CP Titanium Grade 4(Cap) PEEK	N/A
Product Name	MU Gold Cylinder	i-Clean Gold Cylinder
Dimension	Ø 4.8 mm (D) x 14.25 mm (L)	Ø 5.0 mm (D) x 14.3 mm (L)
Material	(Body) Gold Alloy(Plastic Sleeve) Acetal	(Body) Gold Alloy(Plastic Sleeve) Acetal
Product Name	MU Solid Abutment	s-Clean Sole Abutment
Dimension	Ø 4.8 mm (D) x 9.2 / 10.2 / 11.2 / 12.2mm (L)	Ø 4.5 / 5.5 / 6.5 mm (D) x 5.5 mm (L)
Material	Ti-6Al-4V ELI	CP Titanium Grade 4
Product Name	MU Couple Abutment	s-Clean Couple Abutment
Dimension	Ø 4.8 mm (D) x 4.34 / 5.34 / 6.34 /7.34 mm (L)	Ø 4.5 / 5.5 / 6.5 mm (D) x 5.0 / 7.0mm (L)
Material	Ti-6Al-4V ELI	Ti-6Al-4V ELI
Connection	Hex Type	Hex / Non-Hex Type
Product Name	MU Angled Abutment	N/A
Dimension	Ø 4.8 mm (D) x 6.08 / 8.08 / 6.69 / 8.69mm (L)	N/A
Angle	17°, 30°	N/A
Material	Ti-6Al-4V ELI	N/A
Connection	Hex Type	N/A
Product Name	MU Healing Cap	s-Clean Sole Abutment Healing Cap
Dimension	Ø 5.4 mm (D) x 5.0 mm (L)	Ø 4.5 / 5.5 / 6.5 mm (D) x 4.0 mm (L)
Material	Ti-6Al-4V ELI	Acetal
Product Name	MU Abutment Screw	Abutment Screw
Dimension	(1) Ø 1.96 mm (D) x 9.2 mm (L) / 10.2mm (L) / 11.2 mm (L) / 12.2 mm (L)(2) Ø 2.32 mm (D) x 7.8 mm (L)	Ø 2.32 mm (D) x 9.8 mm (L)
Material	Ti-6Al-4V ELI	Ti-6Al-4V ELI
Product Name	MU Retaining Screw	N/A
Dimension	Ø 1.98 mm (D) x 3.7 mm (L)	N/A
Material	Ti-6Al-4V ELI	N/A
Product Name	MU Temporary Cylinder	i-Clean Temporary Abutment
Dimension	Ø 4.8 mm (D) x 10.0 mm (L)	Ø 5.0 mm (D) x 11.5 mm (L)
Material	CP Titanium Grade 4	CP Titanium Grade 4
Product Name	MU CCM Cylinder	N/A
Dimension	Ø 4.8 mm (D) x 14.25 mm (L)	N/A
Material	(Body) Co-Cr-Mo Alloy(Plastic Sleeve) Acetal	N/A
Product Name	Connector	N/A
Dimension	3.8~~7.4 mm (D) x 5.0~~10.1 mm (L)	N/A
Material	Ti-6Al-4V ELI	N/A
Sterilization	Steam sterilization by user	Steam sterilization by user

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Image /page/7/Picture/0 description: The image contains the word "DENTIS" in bold, sans-serif font. To the left of the word is an orange graphic. The graphic is a circle with a curved line extending from the right side of the circle.

9 - Dentis Co., Ltd.
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea
99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea
2806 - 182.53.582.2804 / Fax : 82.53.583.2806

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Dentis Co., Ltc

Image /page/8/Picture/1 description: The image shows the logo for DENTIS. The logo features an orange abstract shape on the left, resembling a stylized flame or a curved leaf. To the right of the shape, the word "DENTIS" is written in a bold, sans-serif font. The overall design is clean and modern.

99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea Tel : 82.53.582.2804 / Fax : 82.53.583.2806

Substantial Equivalence Discussion

The Dentis Dental implant System has a substantially equivalent intended use as the identified predicate. The subject device is similar in fundamental scientific technology to the predicate device in that they all have been designed, manufactured and tested in compliance with FDA's Class II special controls guidance document root-form endosseous dental implants and endosseous dental implant abutment, and they are all constructed of titanium.

The subject and predicate device are similar in indications, design, technology, functions, dimensions and materials.

The differences between the subject and predicate devices are the addition of the 7mm and 14 mm of the fixtures and various abutments to this subject device.

Conclusion

The Dentis Dental Implant System, subject device of this submission, constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its predicate devices. Therefore, Dentis Dental Implant System and its predicate are substantially equivalent.

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.