The ACR Screw System is indicated for use as a fixed anchorage point for the attachment of orthodontic appliances to facilitate the orthodontic movement of teeth for use in patients 12 years of age and older. It is used temporarily and is removed after orthodontic treatment is complete. The screws are intended for single use only.

Device Description

The ACR Screw System is indicated for use as a fixed anchorage point for the attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment is complete. The average temporary implantation period for the anchorage screw is six months. Screws are intended for single use only.

Screws are essentially C-type screw head design and size. Screw diameters and lengths are offered in the following range: thread diameter (1.75 mm) and overall length (11.10 – 15.10 mm). The screw tip has a self-drilling feature for insertion and removal. It is manufactured from a machined piece of Ti-6Al-4V ELI titanium alloy (ASTM F 136-13). These devices are supplied sterilized by gamma irradiation. This device is individually packaged in a polyethylene bag.

AI/ML Overview

The provided document is a 510(k) premarket notification for the ACR Screw System, an orthodontic anchorage screw. It describes the device, its indications for use, and its substantial equivalence to predicate devices, primarily through non-clinical testing. However, it does not contain a study that quantitatively proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or similar measures typically associated with diagnostic or AI-driven devices.

The document focuses on demonstrating physical and material equivalence, as well as safety and basic functionality. Therefore, I cannot fully answer your request for acceptance criteria and a study proving device performance in the way you've outlined for AI/diagnostic devices.

Here's an attempt to extract relevant information given the limitations of the provided text:

1. A table of acceptance criteria and the reported device performance

The document details performance testing related to mechanical properties, biocompatibility, sterilization, bacterial endotoxin, and shelf-life. However, explicit quantitative acceptance criteria and detailed reported performance values for each are not presented in a comparative table within the document. Instead, it states that tests "met predetermined acceptance criteria" or "all test requirements were met."

Test Category	Acceptance Criteria (Stated broadly)	Reported Device Performance (Stated broadly)
Mechanical Properties	In accordance with ISO 19023:2018 and ASTM F543-17 objectives for pull-out, torsion, and torque.	Performance "determined" and implied to be acceptable for substantial equivalence. No specific values provided.
Biocompatibility	In accordance with ISO 10993-1, ISO 10993-5, ISO 10993-12.	Deemed biocompatible due to use of same materials and manufacturing process as previously cleared predicate device (K063495).
Sterilization	Achievement of a Sterility Assurance Level (SAL) of $10^{-6}$ and meeting all test requirements per ISO11137-1, -2, -3.	SAL of $10^{-6}$ was achieved, and all test requirements were met.
Bacterial Endotoxin	Test limit of 0.06 EU/mL per ANSI/AAMI ST72:2011.	Testing met predetermined acceptance criteria.
Shelf-Life	Confirm stability and effectiveness of packaging for 3 years (sterility, peel strength, dye penetration, burst) per ISO 11607-1, ISO 11607-2, ASTM F1980-21.	Device met the acceptance criteria for each test (sterility, peel strength, dye penetration, burst) for a 3-year shelf life.

2. Sample size used for the test set and the data provenance

The document does not specify sample sizes for mechanical, sterilization, bacterial endotoxin, or shelf-life testing. The data provenance is implied to be from internal testing by BioMaterials Korea, Inc. or their contracted labs, primarily from South Korea, as indicated by the manufacturer's and consultant's addresses. All tests are non-clinical (laboratory/bench).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable to the non-clinical testing described. Ground truth for these types of tests is established by standardized testing protocols and measurement instruments, not human expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this is for non-clinical testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical orthodontic screw, not an AI or diagnostic imaging device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical product.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for the non-clinical tests (mechanical properties, biocompatibility, sterilization, etc.) is established by adherence to international standards and validated laboratory test methods (e.g., ISO and ASTM standards for material properties, sterility, and packaging integrity).

8. The sample size for the training set

Not applicable. This device is a physical product, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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

BioMaterials Korea, Inc % Kyung-Hwan Kim Representative Consultant SMB Korea #606, #607, 7, Borame-ro 5ga-gil Donjak-gu Seoul, 07071 Korea. South

8/21/23

Re: K222245

Trade/Device Name: ACR Screw System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: OAT Dated: July 20, 2023 Received: July 21, 2023

Dear Kyung-Hwan Kim:

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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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.

Sherrill Lathrop Blitzer

for Andrew Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222245

Device Name ACR Screw System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X 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 text 'K222245' in a simple, sans-serif font. The text is black and stands out against a white background. The letters and numbers are evenly spaced and clearly legible. The text appears to be a code or identifier.

Image /page/3/Picture/2 description: The image shows the logo for SMB Korea. The logo is in gray and consists of the letters "SMB" followed by "Korea". Underneath the letters is the text "A Member of the Consulting Expert Group" in a smaller font. There is a curved line that starts under the "S" in SMB and extends to the "K" in Korea.

510(k) Summary

For

ACR Screw System

[Complying with 21 CFR 807.92]

l. SUBMISSION SPONSOR

BioMaterials Korea, Inc. #329, #331, #413, 150, Jojeong-daero, Hanam-si, Gyeonggi-do, Republic of Korea Office Phone: +82-31-790-4511 Fax: +82-31-790-4519 Contact Person: Mr. Young-yeop KIM, QMR

II. SUBMISSION CORRESPONDENT

SMB Korea #606, #607, 7, Boramae-ro 5ga-gil, Donjak-gu, Seoul, 07071, Republic of Korea Cell Phone: +82-10-2247-5579 Office Phone: +82-6241-9001 Kyung-hwan KIM, Representative Consultant, QA Contact: Email: info@smbkorea.com

III. DATE PREPARED

August 21, 2023

IV. DEVICE

Trade or Proprietary Name:	ACR Screw System
Common or Usual Name:	Sterile Orthodontic Anchorage Screw
Classification Name:	Implant, Endosseous, Orthodontic (872.3640)
Regulatory Class:	II
Product Code:	OAT
Classification Panel:	Dental

V. PREDICATE DEVICE

Primary Predicate Device: K063495, Orthodontic Anchor Screws of C type and Special type/ BioMaterials Korea, Inc.

Reference Device:

K161335, Dual Top Screw System for orthodontic anchor / Jeil Medical Corporation K182929, BIO-RAY A-1 Anchor Screw System / Microware Precision Co., Ltd.

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Image /page/4/Picture/1 description: The image shows the logo for SMB Korea. The logo is in gray and consists of the letters "SMB" in a bold, sans-serif font, followed by the word "Korea" in a similar font. A curved line extends from under the "S" in SMB to under the "K" in Korea. Below the logo is the text "A Member of the Consulting Expert Group" in a smaller, lighter font.

VI. DEVICE DESCRIPTION

VII. Accessories for the Product, Integral Parts of Package

Not applicable.

VIII. INDICATION FOR USE

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Image /page/5/Picture/1 description: The image shows the logo for SMB Korea. The logo is in gray and consists of the letters "SMB" followed by the word "Korea". Underneath the letters is the text "A Member of the Consulting Expert Group" in a smaller font. The logo is simple and professional.

IX. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

	SUBJECT Device	Primary PREDICATE Device(K063495)	REFERENCE Device(K161335)	REFERENCE Device(K182929)
Manufacturer	BioMaterials Korea, Inc.	BioMaterials Korea, Inc.	Jeil Medical Corporation	Microware Precision Co.,Ltd.
Trade Name	ACR Screw System	Orthodontic Anchor Screwsof C type and Special type	Dual Top Screw System	BIO-RAY A-1 Anchor ScrewSystem
Regulation Description	Implant, Endosseous,Orthodontic	Implant, Endosseous,Orthodontic	Implant, Endosseous,Orthodontic	Implant, Endosseous,Orthodontic
Regulation Number	21 CFR 872.4760	21 CFR 872.4760	21 CFR 872.4760	21 CFR 872.4760
Product Code	OAT	OAT	OAT	OAT
Class	II	II	II	II
Indications for Use	The ACR Screw System isindicated for use as a fixedanchorage point for theattachment of orthodonticappliances to facilitate theorthodontic movement ofteeth for use in patients 12years of age and older. It isused temporarily and isremoved after orthodontictreatment is complete. Thescrews are intended forsingle use only.	Orthodontic Anchor Screwsof C type and Special Typeare intended for use astemporary anchor fororthodontic treatment.	The Dual Top Screw Systemis intended for use as atemporary anchor fororthodontic treatment foruse in patients aged 12 andolder.	The BIO-RAY A-1 AnchorScrew System is intended toprovide fixed anchorage forattachment of orthodonticappliances intended tofacilitate the orthodonticmovement of teeth. It'sused temporarily andintended to be removedafter orthodontic treatmenthas been completed. Thescrew is intended for singleuse only.
Principle of Operation	The ACR Screw System is	Orthodontic anchorage	Orthodontic anchorage	Orthodontic anchorage
	SUBJECT Device	Primary PREDICATE Device(K063495)	REFERENCE Device(K161335)	REFERENCE Device(K182929)
Manufacturer	BioMaterials Korea, Inc.	BioMaterials Korea, Inc.	Jeil Medical Corporation	Microware Precision Co., Ltd.
	placed in both jaws to helpthe orthodontist move theright teeth and keep thewrong teeth from moving inthe wrong direction.	screw is inserted into jawand palatal to help theorthodontist move thecorrect teeth and stop thewrong teeth from moving inthe wrong direction.	screw is inserted into jawand palatal to help theorthodontist move thecorrect teeth and stop thewrong teeth from moving inthe wrong direction.	screw is inserted into jawand palatal to help theorthodontist move thecorrect teeth and stop thewrong teeth from moving inthe wrong direction.
Raw material	Ti-6Al-4V ELI Titanium Alloy(ASTM F 136)	Ti-6Al-4V ELI Titanium Alloy(ASTM F 136)	Ti-6Al-4V ELI Titanium Alloy(ASTM F 136)	Stainless steel 316L (ASTM F138);Ti-6Al-4V ELI Titanium Alloy(ASTM F 136)
Form	Orthodontic AnchorageScrew	Orthodontic AnchorageScrew	Orthodontic AnchorageScrew	Orthodontic AnchorageScrew
Head Structure	[C type]Image: [C type screw]	[C type]Image: [C type screw][CT type]Image: [CT type screw]	[JA]Image: [JA screw][JF]Image: [JF screw]	[A-1PI]Image: [A-1PI screw][A-1 HI]Image: [A-1 HI screw]
	SUBJECT Device	Primary PREDICATE Device(K063495)	REFERENCE Device(K161335)	REFERENCE Device(K182929)
Manufacturer	BioMaterials Korea, Inc.	BioMaterials Korea, Inc.	Jeil Medical Corporation	Microware Precision Co.,Ltd.
			[JB]	[A-1 Torque]
			[G1]	[Bracket]
			[G2]	[IZC]
			[JK]
			[JD]	[M]
			[MIM]	[V]
	SUBJECT Device	Primary PREDICATE Device(K063495)	REFERENCE Device(K161335)	REFERENCE Device(K182929)
Manufacturer	BioMaterials Korea, Inc.	BioMaterials Korea, Inc.	Jeil Medical Corporation	Microwave Precision Co.,Ltd.
			Image: Screw	Image: Screw
Thread Diameter ×Overall Length	Diameter by length:$Ø$ 1.75 mm × 11.10, 13.10,15.10 mm	Length: 4.0 to 11.0 mmDiameter: $Ø$ 1.15 to $Ø$ 2.0 mm	Length: 5.0 mm to 16.0 mmDiameter: $Ø$ 1.3 mm to $Ø$ 2.5 mm	Length: 8.0, 9.0, 10.0, 11.0,12.0, 13.0, 14.0, 15.0, 16.0,17.0 mmDiameter: $Ø$ 1.5 mm to $Ø$ 2.0 mm
Surface Treatment	No surface treatment	No surface treatment	Anodized	Stainless steel screws:Electrolytic polishing;Titanium alloy screws:Anodizing
Sterilization	Sterile (Gamma)	Non-sterile; Steamsterilization prior to use	Non-Sterile (Steam sterilizedby user) or Gamma-Sterilized	Non-sterile; Steamsterilization prior to use
Single Use/Reuse	Single use Only	Single use Only	Single use Only	Single use Only
Biocompatibility	Biocompatible according toISO 10993-1	Biocompatible according toISO 10993-1	Biocompatible according toISO 10993-1	Biocompatible according toISO 10993-1
Performance Testing	ASTM F543-17	ASTM F543-17	ASTM F543-17	ASTM F543-17
SE	The information provided in these 510(k) submissions demonstrates that the ACR Screw System is substantially equivalentto the predicate devices with respect to indications for use, device design, function, and performance with respect to
	SUBJECT Device	Primary PREDICATE Device(K063495)	REFERENCE Device(K161335)	REFERENCE Device(K182929)
Manufacturer	BioMaterials Korea, Inc.	BioMaterials Korea, Inc.	Jeil Medical Corporation	Microware Precision Co.,Ltd.
	technological characteristics. The predicate devices are made of the same material as the subject device, titanium alloy(ASTM F136), the same material as our device. Differences between the subject device and the predicate devices are notexpected to affect the overall performance of the device.
	There are minor differences in thread diameter, overall length, and head design between the subject and predicate devices. However, there is an additional thread length in the subject device compared to the primary predicate device. The difference in length is slight, but the Dual Top Screw System and the BIO-RAY A-1 Anchor Screw System have been used by Jeil Medical Corporation and Microware Precision Co., Ltd. to support these thread lengths; it does not introduce a significantly different design. The technological differences between the subject device and the predicate devices do not impact substantial equivalence, and substantial equivalence is demonstrated by testing in accordance with ISO 19023 and ASTM F543.
	Based on the foregoing, the subject device, the ACR Screw System, is determined to be substantially equivalent (SE) to the predicate devices.

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Image /page/6/Picture/1 description: The image shows the logo for SMB Korea. The logo is in gray and consists of the text "SMB Korea" in a sans-serif font. Below the text is the tagline "A Member of the Consulting Expert Group" in a smaller font. A curved line extends from the bottom of the "S" in SMB to the top of the "K" in Korea.

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Image /page/7/Picture/1 description: The image shows the logo for SMB Korea, which is a member of the Consulting Expert Group. The logo is in gray and features the text "SMB Korea" in a bold, sans-serif font. Below the text is the tagline "A Member of the Consulting Expert Group" in a smaller, lighter font. A curved line extends from the bottom of the "S" in SMB to the top of the "K" in Korea.

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Image /page/8/Picture/1 description: The image shows the logo for SMB Korea. The logo is in gray and features the text "SMB Korea" in a sans-serif font. Below the text is the tagline "A Member of the Consulting Expert Group" in a smaller font. A curved line extends from under the "S" in SMB to under the "K" in Korea.

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Image /page/9/Picture/1 description: The image shows the logo for SMB Korea. The logo is in gray and features the text "SMB Korea" in a sans-serif font. Below the text is the tagline "A Member of the Consulting Expert Group" in a smaller font. The logo is simple and professional, and it conveys the company's focus on consulting and expertise.

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Image /page/10/Picture/1 description: The image shows the logo for SMB Korea, which is a member of the Consulting Expert Group. The logo features the letters "SMB" in a bold, sans-serif font, with the word "Korea" in a lighter, smaller font to the right. A curved line underlines the letters "SMB", and the text "A Member of the Consulting Expert Group" is placed below the line in a smaller font.

X. NONCLINICAL TEST

The following performance data was provided in support of the substantial equivalence determination.

Mechanical Properties

Mechanical testing was performed to determine the pull-out, torsion, and torque of the screw in accordance with ISO 19023:2018, Dentistry – Orthodontic anchor screws; and ASTM F543-17, Standard Specification and Test Methods for Metallic Medical Anchor screw.

Biocompatibility

The ACR Screw System is manufactured using the same manufacturing process and proven materials as the orthodontic screw previously cleared under K063495. Therefore, it is believed that additional biocompatibility testing is not necessary to support the biological safety of the ACR Screw System.

The biocompatibility evaluation and testing were conducted in accordance with the following standards and guidance, as recognized by the FDA:

FDA Guidance - Use of International Standard ISO- 10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing", 2020.
-ISO 10993-5, Biological evaluation of medical device-Part 5: Tests for in vitro cytotoxicity.
-ISO 10993-12, Biological evaluation of medical device-Part 12: Sample preparation and reference materials."

Sterilization Testing

Sterilization validation testing has been performed on the ACR Screw System in accordance with ISO11137-1:2006/Amd 2:2018, ISO 11137-2:2013/Amd 1:2022 and ISO 11137-3:2017. Test results showed that the SAL of 106 was achieved and all test requirements were met.

Bacterial Endotoxin Testing

Bacterial endotoxin testing is performed in accordance with ANSI/AAMI ST72:2011 using the Limulus Amebocyte Lysate (LAL) pyrogen test method at a test limit of 0.06 EU/mL. Testing met predetermined acceptance criteria. Routine monitoring of endotoxins in the manufacturing process is performed quarterly.

Shelf-Life Testing

The ACR Screw System, following to gamma sterilization and packaging was subjected to sterile barrier testing to validate a shelf life of 3 years according to ISO 11607-1:2019, "Packaging for terminally sterilized medical devices – Part 1: Requirements for materials,

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Image /page/11/Picture/1 description: The image shows the logo for SMB Korea. The logo is in gray and consists of the letters "SMB" in a bold, sans-serif font, followed by the word "Korea" in a similar font. A curved line extends from under the "S" in SMB to under the "K" in Korea. Below the logo, in a smaller font, is the text "A Member of the Consulting Expert Group."

sterile barrier systems and packaging systems" and ISO 11607-2:2019, "Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes" confirm the stability and effectiveness of the packaging of the sterilized product during the shelf life, by evaluating changes due to accelerated aging, according to ASTM F1980-21, "Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices".

The ACR Screw System was evaluated using the sterility, peel strength, dye penetration, and burst tests. The device met the acceptance criteria for each test.

XI. CLINICAL TESTS

Clinical data was not provided for ACR Screw System.

XII. CONCLUSIONS

The ACR Screw System and the predicate devices have the substantially equivalent indications for use, the same raw materials, the same range of physical dimensions, and the same characteristics. In addition, the substantial equivalence of the predicate devices has been confirmed through non-clinical testing. Therefore, the ACR Screw System has been demonstrated to be equivalent to the predicate devices.

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.