The three implants of the Trefoil system are placed between the mental foramina in fully edentulous mandibles in a 1-stage surgical technique combined with an immediate function loading protocol, provided sufficient primary stability for the selected technique is achieved. In cases where sufficient primary stability of one or more implants is not reached, the implants along with the bar may also be used with an early or delayed loading protocol.

The following prerequisites must be fulfilled:

Adequate quantity of bone (minimum width of 7mm; and minimum heights of 13mm for 11.5 mm implant and 14.5mm for 13.0 mm implant).
Adequate mouth opening (minimum 40 mm) to accommodate the guided surgery instruments.
Implant-supported prosthetics seated directly on dedicated implants.

Device Description

The TREFOIL System is a method of placing three dental implants in predetermined positions (between the mental foramina) and using a pre-designed prosthetic bar to act as a screw-retained framework seated on the implants. The TREFOIL System restores chewing function and esthetics in the mandible in completely edentulous patients.

The TREFOIL System consists of dental implants, surgical components necessary to place the implants in predetermined positions, and prosthetic components that are included in the prosthetic bar or are used in the dental lab during the creation of the prosthetic bar.

The dental implants are threaded endosseous implants made of CP4 titanium. The implant is parallel walled and has an internal connection. The implant is available in three diameters 4.3, 5.0, and 5.5 mm. All three diameters are available in lengths of 11.5 and 13mm and have a 4.5 mm tissue collar that has a smooth machined surface without threads. The apex of the implants has cutting chambers allowing for self-tapping. The implant bone interface has the TiUnite implant surface treatment. The TREFOIL System bar is made of titanium vanadium alloy. The TREFOIL System surgical tooling is made of stainless steel.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "TREFOIL System," an endosseous dental implant. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove acceptance criteria for a new AI/software device.

Therefore, many of the requested categories for AI/software acceptance criteria and study details are not directly applicable to this document. The document describes mechanical and material testing for the dental implant system.

Below is an attempt to extract relevant information and note where the requested details are not present in this type of submission.

This document describes the TREFOIL System, an endosseous dental implant system, and its substantial equivalence to a predicate device, K152836 (also TREFOIL System). The performance data presented refers to fatigue testing and biocompatibility testing to demonstrate the device meets its design requirements and is safe for use.

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

Acceptance Criteria Category	Acceptance Criteria (Implicit from testing)	Reported Device Performance
Fatigue Strength	Withstand foreseeable mastication forces (per ISO 14801)	Significantly higher fatigue strength than the predicate TREFOIL System (K152836)
Biocompatibility	Meet standards for biological safety (per CEN EN ISO 10993-5, CEN EN ISO 10993-12, CEN EN ISO 10993-18)	Compliant with standards (testing performed)
Sterilization	Validated per ANSI/AAMI/ISO 11137	Validated (same as predicate)
Packaging	Adequate for maintaining sterility and integrity	Same as predicate (plastic vial/thermoform tray)
Shelf Life	Maintain integrity and functionality for specified duration	5 years for implants, 3 years for drills/screw taps (real-time aging)
Material Equivalence	Same material as predicate, same manufacturing, intended use, and patient contact	Same CP titanium for implants, stainless steel for tooling, titanium vanadium alloy for bar

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The document does not specify the exact number of samples used for the fatigue testing or biocompatibility testing. It generally refers to "testing performed."
Data Provenance: Not specified, but generally refers to laboratory testing performed by the manufacturer. These are bench tests, not human studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to this type of device submission. There is no human "ground truth" to establish for mechanical and material testing of an implanted medical device. The "ground truth" here is the adherence to established engineering and material science standards (e.g., ISO 14801).

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

This question is not applicable. Adjudication methods like 2+1 are used in clinical studies, typically for diagnostic or screening devices where human interpretation is involved. For a mechanical implant device, performance is measured against objective physical standards.

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

This question is not applicable. This document is for a physical medical device (dental implant system), not an AI or software device involving human readers or interpretation of medical images.

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

This question is not applicable. This is not an algorithm or software device.

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

The "ground truth" for this device's performance is objective measurements against international standards (e.g., ISO 14801 for fatigue testing, CEN EN ISO 10993 for biocompatibility) and comparison to the performance of the legally marketed predicate device. It is based on engineering principles and material science.

8. The sample size for the training set

This question is not applicable. This is not an AI/machine learning device that would require training data.

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

This question is not applicable. This is not an AI/machine learning device.

Summary

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Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.

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

May 11, 2017

Nobel Biocare AB % Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887

Re: K170135

Trade/Device Name: TREFOIL System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA, DZI Dated: April 5, 2017 Received: April 6, 2017

Dear Charlemagne Chua:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.

Michael J. Ryan -S

for Tina Kiang, Ph.D. 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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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

510(k) Number (if known)	K170135
Device Name	TREFOIL System
Indications for Use (Describe)
The Trefoil system is used to restore chewing function in fully edentulous mandibles.
The three implants of the Trefoil system are placed between the mental foramina in fully edentulous mandibles in a 1-stage surgical technique combined with an immediate function loading protocol, provided sufficient primary stability for the selected technique is achieved. In cases where sufficient primary stability of one or more implants is not reached, the implants along with the bar may also be used with an early or delayed loading protocol.
The following prerequisites must be fulfilled:
- Adequate quantity of bone (minimum width of 7mm; and minimum heights of 13mm for 11.5 mm implant and 14.5mm for 13.0 mm implant).
- Adequate mouth opening (minimum 40 mm) to accommodate the guided surgery instruments.
- Implant-supported prosthetics seated directly on dedicated implants.
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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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FORM FDA 3881 (1/14)	Page 1 of 1
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K170135-S001: Al Response (13 MAR 2017)

Page 8 of 32

PSC Publishing Services (301) 443-6740

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I. SUBMITTER

Nobel Biocare AB Vastra Hamngatan 1 Goteborg, SE-411 17 Sweden

Submitted by Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887

Contact Person: Charlemagne Chua, Senior Regulatory Affairs Manager Phone: (714) 282-4800 x 7830 Fax: (714) 998-9348

Date Prepared: April 5, 2017

II. DEVICE

Name of Device: TREFOIL System Common or Usual Name: Endosseous Dental Implant Classification Name: Endosseous Dental Implant (21 CFR 872.3640) Regulatory Class: II Primary Product Code: DZE Other Product Code(s): NHA, DZI

III. PREDICATE DEVICE

Primary predicate: Nobel Biocare - TREFOIL System (K152836) This predicate has not been subject to a design-related recall.

Reference predicate: Nobel Biocare - NobelSpeedy Implants (K050406) This predicate has not been subject to a design-related recall

IV. DEVICE DESCRIPTION

The dental implants are threaded endosseous implants made of CP4 titanium. The implant is parallel walled and has an internal connection. The implant is available in three

Nobel Biocare Traditional 510(k) Notification TREFOIL System April 2017

A.4.

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diameters 4.3, 5.0, and 5.5 mm. All three diameters are available in lengths of 11.5 and 13mm and have a 4.5 mm tissue collar that has a smooth machined surface without threads. The apex of the implants has cutting chambers allowing for self-tapping. The implant bone interface has the TiUnite implant surface treatment. The TREFOIL System bar is made of titanium vanadium alloy. The TREFOIL System surgical tooling is made of stainless steel.

V. INDICATIONS FOR USE

The Trefoil system is used to restore chewing function in fully edentulous mandibles.

The three implants of the Trefoil system are placed between the mental foramina in fully edentulous mandibles in a 1-stage surqical technique combined with an immediate function loading provided sufficient primary stability for the selected technique is achieved. In cases where sufficient primary stability of one or more implants is not reached, the implants along with the bar may also be used with an early or delayed loading protocol.

The following prerequisites must be fulfilled:

Adequate quantity of bone (minimum width of 7mm; and minimum heights of 13mm for -11.5 mm implant and 14.5mm for 13.0 mm implant).
-Adequate mouth opening (minimum 40 mm) to accommodate the guided surgery instruments.
-Implant-supported prosthetics seated directly on dedicated implants.

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VI. Comparison of Technological Characteristics

Comparison of intended use and indication for use statement

Technologicalcharacteristics	Subject Device	Primary Predicate
Intended use	TREFOIL System	TREFOIL System (K152836)
	The TREFOIL System is intended for the intraoral treatment of totallyedentulous mandibles by providing anchorage of the framework inorder to restore chewing function and esthetics. By the aid of thesurgical components (guides and templates etc.) three implants areplaced in predetermined positions, corresponding to the pre-fabricated prosthetic Framework that is used.	The TREFOIL System is intended for the intraoral treatment of totallyedentulous mandibles by providing anchorage of the framework inorder to restore chewing function and esthetics. By the aid of thesurgical components (guides and templates etc.) three implants areplaced in predetermined positions, corresponding to the pre-fabricated prosthetic Framework that is used.
Indication foruse statement	The Trefoil system is used to restore chewing function in fullyedentulous mandibles.	The TREFOIL System is used to restore chewing function infully edentulous mandibles.
	The three implants of the Trefoil system are placed betweenthe mental foramina in fully edentulous mandibles in a 1-stagesurgical technique combined with an immediate functionloading protocol, provided sufficient primary stability for theselected technique is achieved. In cases where sufficientprimary stability of one or more implants is not reached, theimplants along with the bar may also be used with an early ordelayed loading protocol.	The three implants of the TREFOIL System are placedbetween the mental foramina in fully edentulous mandibles ina 1-stage surgical technique combined with an immediatefunction loading protocol, provided sufficient primary stabilityfor the selected technique is achieved. In cases wheresufficient primary stability for two implants or more is notreached, the implants along with the Framework may also beused with an early or delayed loading protocol.
	The following prerequisites must be fulfilled:- Adequate quantity of bone (minimum width of 7mm; andminimum heights of 13mm for 11.5 mm implant and14.5mm [for 13.0 mm implant). Adequate mouth opening(minimum 40 mm) to accommodate the guided surgeryinstruments.Implant-supported prosthetics seated directly on dedicatedimplants.	The following prerequisites must be fulfilled:- Adequate quantity of bone (minimum height of 13mm andminimum width of 6- 7mm).Adequate mouth opening (minimum 40 mm) toaccommodate the guided surgery instruments.Implant-supported prosthetics seated directly on dedicatedimplants
Comparison of Intended use/Indications for Use: The intended use of the updated TREFOIL System is the same as the predicate TREFOIL System. The firstbullet in the prerequisite list of the Indications for use statement has been modified to reflect the change in implant body design. This change is within thedimensions listed on the predicate indication for use. Additionally, a change in the indications for use was added to ensure 1.5mm of structural support below theimplants for the 13.0 mm implants. The indication for use has also been changed to increase the amount of implants reaching primary stability needed forimmediate function from 2 to 3. This change is also within the current predicate range and reduces the possibility of implant mobility.

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Comparison of Implant Technological Characteristics

Technologicalcharacteristics	Subject Device	Primary Predicate	Reference Predicate
Implant Design Features	TREFOIL System	TREFOIL System (K152836)	NobelSpeedy Implants (K050406)
	ImplantBody Design	Parallel walled	Parallel walled	Parallel walled
	Implant TipDesign	Tapered self cutting	Tapered self cutting	Tapered self cutting
	ImplantLength	16.0 mm overall (11.5 mm body w/ 4.5 mm collar)17.5 mm overall (13.0 mm body w/ 4.5 mm collar)	16.0 mm overall (11.5 mm body w/ 4.5 mm collar)17.5 mm overall (11.5 mm body w/ 6.0 mm collar)	7, 8.5, 10, 11.5, 13.0, 15.0, 18.0 mm
	ImplantDiameter	4.3, 5.0, 5.5 mm	4.93 mm	4.0, 5.0, 6.0 mm
	CollarDiameter	4.5 mm	4.5 mm	4.1, 5.1, 5.8 mm
	Collar Height	4.5 mm	4.5, 6.0 mm	N/A
	ConnectionType	Morse taper with Internal Hex	Morse taper with Internal Hex	External hexInternal Tri-Lobe
	DeviceMaterial	CP titanium	CP titanium	CP titanium
	Surfacemodification	TiUnite (anodic oxidation)	TiUnite (anodic oxidation)	TiUnite (anodic oxidation)

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Comparison of Framework Bar Technological Characteristics

Technologicalcharacteristics	Subject Device	Primary Predicate
	TREFOIL System	TREFOIL System (K152836)
Bar Design Features	Bar Design	Preshaped single piece design screw retained to implant.	Preshaped single piece design screw retained to implant.
	Intended platform	TREFOIL implant (intenal conical connection)	TREFOIL implant (intenal conical connection with snap fit)
	Materials	Titanium vanadium alloy	Titanium vanadium alloy
	Surface modification	Machined titanium	Machined titanium
	Compensation mechanism	Round abutment and corresponding framework and screw disks	Round abutment and corresponding framework and screw disks
	Prosthetic media	Acrylic	Acrylic
	Fixed cantilever length	18.8 mm	18.8 mm

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Technologicalcharacteristics			Subject Device	Primary Predicate
			TREFOIL System	TREFOIL System (K152836)
Surgical tooling type	Drill	Diameter	2.0, 2.4/2.8, 3.2/3.6, 3.8/4.2, 4.2/4.6, 4.2/5.0 mm	2.0, 3.0, 3.8, 4.0, 4.2, 4.4 mm
		Material	Stainless SteelDLC coated	Stainless SteelDLC coated
		Connection	ISO 1797 Type 1	ISO 1797 Type 1
		Markings	All drills marked for 11.5 mm and 13.5 mm length implants	All drills marked for 11.5 mm and 13.5 mm length implants
		Intended use	The drills are used together with corresponding Templates fordrills for the preparation of the implant sites	The drills are used together with corresponding Templates fordrills for the preparation of the implant sites.
		Diameter	4.3, 5.0, 5.5 mm	5.0 mm
		Materials	Stainless SteelDLC coated	Stainless SteelDLC coated
		Connection	ISO 1797 Type 1	ISO 1797 Type 1
		Intended use	The screw tap is used when dense bone is present toprepare for the threaded implant	The screw tap is used when dense bone is present to prepare forthe threaded implant
		Length	14.0 mm (to stop)19.7 mm (overall)	14.0 mm (to stop)19.3 mm (overall)
		Materials	Stainless Steel	Stainless Steel
		Intended use	The stabilizing screw is used to temporarily connect the V-template to the alveolar ridge	The stabilizing screw is used to temporarily connect the V-template to the alveolar ridge

Comparison of Surgical Tooling Technological Characteristics

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Analysis of Differences Between Subject Device and Predicate

Indications for use

The first bullet in the prerequisite list has been modified to reflect the change in implant body design. This change is within the dimensions listed on the predicate indication for use. Additionally, a change in the indications for use was added to ensure 1.5mm of structural support below the implants for the 13.0 mm implants. The indication has also been changed to increase the amount of implants reaching primary stability needed for immediate function from 2 to 3. This change is also within the current predicate range and reduces the possibility of implant mobility.

Implant technological characteristics

The subject Trefoil implant is a hybrid between the existing Trefoil implant (K152836) and the NobelSpeedy implant (K050406). The subject Trefoil implant has the basic collar and abutment connection as the existing Trefoil implant (K152836) and body design characteristics of the NobelSpeedy implant (K050406). The subject Trefoil implant now has one collar length and two implant body lengths. This maintains the same overall implant lengths as the predicate Trefoil implant (K152836). The available subject Trefoil implant body diameters are different from but within the range of the NobelSpeedy implant (K050406). The subject Trefoil implant was tested using a modified ISO 14801 test protocol and the results favorably compared to the Trefoil implant (K152836).

Framework technological characteristics

The subject TREFOIL System uses the same framework components as the TREFOIL System (K152836) with one exception. The framework no longer has a snap fit. This was done by modifying the round abutment. The subject Trefoil implant and Framework was tested using a modified ISO 14801 test protocol and the results favorably compared to the Trefoil implant (K152836).

Surgical Tooling

The drill for the subject TREFOIL System uses the same materials and basic design but have been modified to accommodate the new Trefoil Implant body profile.

Summary:

The design differences between subject and predicate were evaluated using comparative testing. Differences in technology were evaluated through comparative performance testing.

VII. PERFORMANCE DATA

Summary of Non-Clinical Testing:

Since the subject device does not represent a new worst case, data from the predicate device was leveraged in the following aspects of the 510(k).

-Sterile Device Information
- The sterilization method for the Trefoil Implants, drills, and screw taps is the o same as the predicate. The sterilization method is Gamma radiation and has been validated in accordance with ANSI/AAMI/ISO 11137. Therefore, no additional testing was required.
-Device Packaging
- The packaging for the subject device is the same as the predicate. This is either O a plastic vial with PVC shrink-wrap cap (Trefoil Implants) or a thermoform tray with peel top lid (Trefoil drills and screw taps). Therefore, no additional testing was required.

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Shelf Life
- o The packaging for the subject device is the same as the predicate and is labeled with either a 5 vear expiration date (Trefoil Implants) or a 3 vear expiration (Trefoil drills and screw taps). Real time aging was used to determine the expiration dating. Therefore, no additional testing was required.
Biocompatibility
- o The Trefoil Implants, drills, screw taps, are manufactured from the same material as the predicate, uses the same manufacturing method as the predicate, has the same intended use, and the same patient contact type and duration. Therefore, no additional testing was required.

Fatigue testing was performed to establish that the TREFOIL System will withstand foreseeable mastication forces. Fatique testing was done by using a test scenario developed for splinted implant applications. Fatigue testing was conducted and results analyzed in accordance with ISO 14801. The results demonstrate significantly higher fatigue strength than the predicate TREFOIL System (K152836).

Biocompatibility testing for the TREFOIL framework assembly and Stabilizing Screw V-Template was performed in accordance with CEN EN ISO 10993-5, CEN EN ISO 10993-12, and CEN EN ISO 10993-18.

No clinical data was used to support the decision of substantial equivalence.

VIII. CONCLUSIONS

The TREFOIL System was evaluated for substantial equivalence using standard and/or comparative testing. In cases where the TREFOIL System could be shown to not represent a worst-case with respect to the predicates, data from these predicate devices was leveraged to support the subject device. Based on technological characteristics and non-clinical test data included in this submission, the TREFOIL System shown to be substantially equivalent to the TREFOIL System (K152836).

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.