s-Clean SQ-SL Implant System Regular is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. This system is intended for delayed loading.

Device Description

s-Clean SQ-SL Implant System Regular is composed of Fixture and Abutments. s-Clean SQ-SL Fixture is a thread type implant made of Commercial Pure Titanium Grade 4 according to ASTM F67 which will be placed in the alveolar bone to replace the function of the missing tooth. The device has an internal connection between the implant body and the abutment component. Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). The implant body is the only part to be implanted into bone (mandibular or maxillary bone), and is to be connected to the abutment. Abutments are composed as below; s-Clean Sole Abutment S-Line, s-Clean TiN Half Coating Sole Abutment S-Line, and s-Clean Cover Screw.

AI/ML Overview

The provided text describes the regulatory clearance of a dental implant system (s-Clean SQ-SL Implant System Regular) through the 510(k) pathway, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study to establish performance against specific clinical acceptance criteria.

Therefore, the document does not contain information related to acceptance criteria, a clinical study proving device performance against such criteria, sample sizes, expert involvement for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment for training sets, as these are typically part of a different type of submission (e.g., PMA or de novo) or a separate clinical validation study.

Instead, the document details non-clinical test data performed to demonstrate substantial equivalence to predicate devices.

Here's the information that can be extracted from the provided text regarding device testing:

Non-Clinical Test Data and Performance (as described in the document):

Acceptance Criteria (Standard Met)	Reported Device Performance
Bacterial Endotoxin Test (ANSI/AAMI ST72:2011, USP <161>, USP <85>)	"The results of the above tests have met the criteria of the standards"
Shelf Life Test (ASTM F1980)	"The results of the above tests have met the criteria of the standards"
Sterilization Validation Test (ISO 11137-1,2,3 for subject fixtures, leveraged from K153639)	"The results of the above tests have met the criteria of the standards"
Sterilization Validation Test (ISO 11137-1,2,3 for subject Cover Screw, leveraged from K171027)	"The results of the above tests have met the criteria of the standards"
Shelf Life Test (ISO 11137-1,2,3 for subject Cover Screw, leveraged from K171027)	"The results of the above tests have met the criteria of the standards"
End User Sterilization Validation Test (ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, ISO 11138-1 for abutments, leveraged from K171027)	"The results of the above tests have met the criteria of the standards"
Biocompatibility testing (ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-6:2007, ISO 10993-10:2010, ISO 10993-11:2006 for fixtures, leveraged from K153639)	"The results of the above tests have met the criteria of the standards"
Biocompatibility testing (ISO 10993-1:2009 for machined surface abutments, leveraged from K171027)	"The results of the above tests have met the criteria of the standards"
Biocompatibility testing (ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2006 for s-Clean TiN Coating Abutments, leveraged from K171694)	"The results of the above tests have met the criteria of the standards"
Biocompatibility Testing (ISO 10993-1:2009 for Cover Screw, leveraged from K171027)	"The results of the above tests have met the criteria of the standards"

Information Not Available in the Document:

Sample sized used for the test set and the data provenance: Not applicable as no clinical test set for performance evaluation is described. The non-clinical tests were conducted on device components.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no described test set requiring expert ground truth for clinical performance.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a dental implant system, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a dental implant system, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for the non-clinical tests was the adherence to the specified international and national standards.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary of the study/evidence provided:

The submission for the s-Clean SQ-SL Implant System Regular relies on a non-clinical testing approach to demonstrate substantial equivalence to its predicate devices, as typically done for Class II medical devices through the 510(k) pathway. The study involves demonstrating that the subject device meets various established biomaterials, sterilization, and shelf-life standards (e.g., ASTM, ISO, ANSI/AAMI, USP). In many cases, the results from specific tests conducted on the predicate devices (K153639, K171027, K171694) were leveraged to support the substantial equivalence of the subject device, implying that the subject device's design, materials, and manufacturing processes are sufficiently similar to those already proven safe and effective. The document explicitly states that "The results of the above tests have met the criteria of the standards, and demonstrated the substantial equivalence with the predicate device." It also notes that fatigue testing per ISO 14801 was not conducted as it was deemed unnecessary based on device-specific guidance.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 4, 2020

Dentis Co., Ltd. % April Lee Consultant Withus Group Inc. 106 Superior Irvine, California 92620

Re: K192688

Trade/Device Name: s-Clean SQ-SL Implant System Regular Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: November 2, 2019 Received: November 12, 2019

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. 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 medical devices and radiation-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

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Indications for Use

510(k) Number (if known) K192688

Device Name s-Clean SQ-SL Implant System Regular

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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Image /page/3/Picture/1 description: The image shows the word "DENTIS" in bold, black letters. To the left of the word is an orange, abstract symbol that resembles a stylized flame or a curved shape with a circular element. The logo appears to be for a company or organization named "DENTIS."

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. Gyu Ri Kim 99, Seongseoseo-ro, Dalseo-gu Daegu, 42718 Korea Email: kgr1026@dentis.co.kr Tel. +82-53-589-3541 Fax. +82-53-289-7922

Official Correspondent

Withus Group Inc. April Lee 106 Superior, Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122

Device Information

Trade Name: s-Clean SQ-SL Implant System Regular
Common Name: Dental Implant System
Classification Name: implant, endosseous, root-form
Product Code: DZE
. Secondary Product Code: NHA
Panel: Dental
Regulation Number: 21 CFR 872.3640
Device Class: Class II ●
Date Prepared: 01/28/2020

Predicate Devices:

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

Primary Predicate

K153639, OneQ-SL s-Clean Implant System by Dentis Co., Ltd. ●

Reference Predicates

K171027, Dentis Dental Implant System by Dentis Co., Ltd.
K171694, s-Clean TiN Coating Abutments by Dentis Co., Ltd.

Indication for Use:

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Image /page/4/Picture/1 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.

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

Device Description:

Fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching).

The implant body is the only part to be implanted into bone (mandibular or maxillary bone), and is to be connected to the abutment.

The dimensions are as following:

Name	Diameter (mm)	Length (mm)
s-Clean SQ-SL Fixture	Ø4.1/Ø4.35/Ø4.8	7.0, 7.5, 9.5, 11.5, 13.5
s-Clean SQ-SL Fixture	Ø5.8/Ø6.8/Ø7.8	7.0, 7.5, 9.5, 11.5

Abutments are composed as below;

s-Clean Sole Abutment S-Line, s-Clean TiN Half Coating Sole Abutment S-Line, and s-Clean Cover Screw.

The dimensions of abutments are as following:

No.	Device Name	Dimensions	Angulation
1	s-Clean Sole AbutmentS-Line	Ø4.5, 5.5, and 6.5 mm(D) X 1.8, 2.8 and 3.8mm(Gingival Height) X 4.0mm (Post Height)	0°
2	s-Clean TiN Half CoatingSole Abutment S-Line	Ø4.5, 5.5, and 6.5 mm (D) X 1.8, 2.8 and 3.8mm(Gingival Height) X 4.0mm (Post Height)	0°
3	s-Clean Cover Screw	Ø3.6mm (D) X 5.9mm (L)	0°

The Abutments have below featured:

Name	Uses	Surface	Connection
s-Clean Sole Abutment S-Line	The Abutment is connected with fixtureand it supports prosthesis which restorestooth function.	N/A	Internal Hex
s-Clean TiN Half CoatingSole Abutment S-Line		TiN-Coating	Internal Hex
s-Clean Cover Screw	It is used for protecting inner hole andconnecting part with exposed upper partof structure during the healing period afterinserting dental implant fixture	N/A	Screw Retained

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Dentis Co., Ltd.

Image /page/5/Picture/1 description: The image contains the logo for DENTIS. The logo features an orange circular design on the left, followed by the word "DENTIS" in a bold, sans-serif font. The overall design is simple and professional.

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

Materials:

The s-Clean SQ-SL Fixture and s-Clean Cover Screw are fabricated from Commercial Pure Titanium . Grade 4 of ASTM F67
. The s-Clean Sole Abutment S-Line and s-Clean TiN Half Coating Sole Abutment S-Line are fabricated from Ti-6Al-4V ELI of ASTM F136

Summaries of Technology Characteristics:

s-Clean SQ-SL Fixture

	Subject Device	Primary Predicate Device
510(k) Number	N/A	K153639
Trade Name	s-Clean SQ-SL Implant System Regular	OneQ-SL s-Clean Implant System
Manufacturer	Dentis Co., Ltd.	Dentis Co., Ltd.
Design(Fixture Type)	Image: Two implants- Internal Hex-connected- Submerged Fixture- Bone level- Tapered body- cutting edge with self-tapping	Image: Two implants- Internal Hex-connected- Submerged Fixture- Bone Level- Tapered & Straight Body- 3 sided cutting edge with self-tapping
Fixture Diameter(Ø)	Regular: 4.1, 4.35, 4.8Wide: 5.8, 6.8, 7.8	Regular: 3.7,3.9,4.2,4.7,5.2Wide: 6.0,7.0,8.0
Fixture Length	Regular: 7,7.5,9.5,11.5,13.5mmWide: 7,7.5,9.5,11.5mm	Regular: 7,8,10,12,14mmWide: 7,8,10,12mm
Indication for Use	s-Clean SQ-SL Implant System Regular isindicated for use in partially or fullyedentulous mandibles and maxillae, in supportof single or multiple unit restorationsincluding; cemented retained, screw retained,or overdenture restorations, and terminal orintermediate abutment support for fixedbridgework. This system is dedicated for oneand two stage surgical procedures and notdedicated for immediate loading. This systemis intended for delayed loading.	The OneQ-SL s-Clean Implant System isindicated for use in partially or fully edentulousmandibles and maxillae, in support of single ormultiple unit restorations including; cementedretained, screw retained, or overdenturerestorations, and terminal or intermediateabutment support for fixed bridgework. Thissystem is dedicated for one and two stagesurgical procedures and not dedicated forimmediate loading. This system is intended fordelayed loading.
Surface Treatment	SLA	SLA
Material	CP Titanium Grade 4	CP Titanium Grade 4
	(ASTM F67)	(ASTM F67)
Similarities	s-Clean SQ-SL Implant System Regular has similar device characteristics with thePrimary predicate devices, OneQ-SL s-Clean Implant System (K153639) such as Length,material, functions, general shape (Design), manufacturing process, and surface treatmentare similar. The indications for Use are identical between two devices and that otherreference devices used in this submission do not include any component-specificlanguage that would be needed in the subject Indications for Use.
Differences	The differences are the macro shape of the implant body and small differences in thedimensions proposed; we have provided all descriptive information related to shape andthe primary predicate includes the subject device range of dimensions. Therefore, thesedifferences do not impact substantial equivalence.

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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 overall impression is that of a logo or brand name.

Dentis Co., Ltd.

99, Seongseoseo-ro, Dalseo-gu, Daegu, Korea

s-Clean Sole Abutment S-Line

	Subject Device	Reference Device
510(k) Number	N/A	K171027
Trade Name	s-Clean SQ-SL Implant System Regular	Dentis Dental Implant System
Manufacturer	Dentis Co., Ltd.	Dentis Co., Ltd.
Product Name	s-Clean Sole Abutment S-Line	s-Clean Sole Abutment
Design	Image: s-Clean Sole Abutment S-Line	Image: s-Clean Sole Abutment
Dimension	Ø4.5: 11.6, 12.6, 13.6mmØ5.5: 11.6, 12.6, 13.6mmØ6.5: 11.6, 12.6, 13.6mm	Ø4.5: 12.5 – 17mmØ4.8: 12 – 17mmØ5.5: 12.5 – 17mmØ6.0: 13 – 17mmØ6.5: 12.5 – 17mm
Angulation	N/A	N/A
Material	Ti-6Al-4V ELI (ASTM F136)	Ti-6Al-4V ELI (ASTM F136)
Brief Comparison	The general design is similar to the reference device; the differences are minordifferences in design and dimensions, though the subject device range of dimensions isincluded in the reference device. The apparently smaller total length does not impactsubstantial equivalence as the post height is at least 4mm, which is clinicallyrecommended.

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Image /page/7/Picture/0 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 gradient of orange colors.

Dentis Co., Ltd

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

	Subject Device	Reference Device
510(k) Number	N/A	K171694
Trade Name	s-Clean SQ-SL Implant System Regular	s-Clean TiN Coating Abutments
Manufacturer	Dentis Co., Ltd.	Dentis Co., Ltd.
Product Name	s-Clean TiN Half Coating Sole Abutment S-Line	s-Clean TiN Partial Coating Sole Abutment
Design	Image: Subject Device Design	Image: Reference Device Design
Dimension	Ø4.5: 11.6, 12.6, 13.6mmØ5.5: 11.6, 12.6, 13.6mmØ6.5: 11.6, 12.6, 13.6mm	Ø4.5: 8.8 - 13.3mmØ4.8: 9.3 - 13.3mmØ5.5: 8.8 - 13.3mmØ6.0: 9.3 - 13.3mmØ6.5: 8.8 - 13.3mm
Angulation	N/A	N/A
Material	Ti-6Al-4V ELI (ASTM F136)	Ti-6Al-4V ELI (ASTM F136)
Coating	TiN Coating	TiN Coating
Brief Comparison	The general design is similar to the reference device; the differences are minor differences indesign and dimensions, though the subject device range of dimensions is included in thereference device. The apparently smaller total length does not impact substantial equivalence asthe post height is at least 4mm, which is clinically recommended.

s-Clean TiN Half Coating Sole Abutment S-Line

Substantial Equivalence Discussion

Similarities:

s-Clean SQ-SL Implant System Regular has similar device characteristics with the Primary predicate devices, OneQ-SL s-Clean Implant System (K153639) such as Length, material, functions, general shape (Design), manufacturing process, and surface treatment are similar. The indications for Use are identical between two devices and that other reference devices used in this submission do not include any component-specific language that would be needed in the subject Indications for Use.

Differences:

The differences are the macro shape of the implant body and small differences in the dimensions proposed; we have provided all descriptive information related to shape and the predicates include the subject device range of dimensions. Therefore, these differences do not impact substantial equivalence.

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Image /page/8/Picture/0 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 on the right. The abstract shape appears to be a stylized letter "D" or a flame-like design.

Dentis Co., Ltd

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

Non-Clinical Test Data

The subject device was tested to evaluate its substantial equivalence according to the following standards.

Bacterial Endotoxin Test Report on Subject Fixture according to ANSI/AAMI ST72:2011, USP ● <161>, and USP <85>
. Shelf Life Test for subject fixtures according to ASTM F1980

Below tests were performed for predicate devices and leveraged for the subject device:

. Sterilization Validation Test for subject fixtures according to ISO 11137-1,2,3 referenced in K153639
Sterilization Validation Test on s-Clean Healing Abutment for subject Cover Screw according ● to ISO 11137-1,2,3 referenced in K171027
Shelf Life Test on s-Clean Healing Abutment for subject Cover Screw according to ISO ● 11137-1,2,3 referenced in K171027
End User Sterilization Validation Test Report for subject abutments according to ANSI/AAMI . ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1 referenced in K171027
Biocompatibility testing according to ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-. 5:2009, ISO 10993-6:2007, ISO 10993-10:2010 and ISO 10993-11:2006 on fixtures referenced in K153639
. Biocompatibility testing according to ISO 10993-1:2009 on machined surface abutments referenced in K171027.
. Biocompatibility testing according to ISO 10993-3:2014. ISO 10993-5:2009. ISO 10993-10:2010, and ISO 10993-11:2006 ISO on s-Clean TiN Coating Abutments in K171694
. Biocompatibility Testing according to ISO 10993-1:2009 on Cover Screw referenced in K171027.

The results of the above tests have met the criteria of the standards, and demonstrated the substantial equivalence with the predicate device. The fatigue testing per ISO 14801 was not conducted as it is not necessary based on the device-specific guidance document

The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device.

Conclusion

s-Clean SQ-SL Implant System Regular constitutes a substantially equivalent medical device. This system has the same intended use and fundamental scientific technology as its predicate devices. Any additional small differences do not impact substantial equivalence. Therefore, s-Clean SO-SL Implant System Regular and its predicates 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.