Zimmer 3.1mmD Dental Implants are designed for use in the anterior maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. Zimmer 3.1mmD Dental Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to minimally support the implant (minimum 1mm circumferential and 2mm apical). The Zimmer 3.1mmD Dental Implants should be splinted to additional implants when used in the pre-molar region and should not be used in the molar region.

The 2.9mm Angled Abutment and the 2.9mm Angled Abutment, Straight Hex are used for attachment of restorations requiring off-axis correction. The 2.9mm Angled Abutment and the 2.9mm Angled Abutment, Straight Hex are designed to be used in edentulous or partially edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a freestanding single tooth replacement.

The 2.9mm Contour Abutment and the 2.9mm Contour Abutment, Straight Hex are used as a terminal or intermediate abutment for a cemented prosthesis. Abutment can be used for a singleor multiple-unit restoration. The 2.9mm Angled Contour Abutment and the 2.9mm Angled Contour Abutment, Straight Hex are designed to be used as a terminal or intermediate abutment for a cemented prosthesis where the angle needs to be offset by 17°. Abutment can be used for a single- or multiple-unit restoration.

The 2.9mm Temporary Abutment is intended to be used to fabricate and support provisional restorations that aid in creating an esthetic emergence through the gingiva during the healing period and prior to final restoration. The 2.9mm Temporary Abutment can be used for cementretained or screw-retained provisional restorations. The abutments can be used for single-unit and multi-unit restorations.

The Ball Abutment is used for retaining overdentures or partial dentures when resilience and facilitated oral hygiene are desired.

The Healing Collar is used to assist in the forming of the soft tissue during healing before a final restoration is placed. The Healing Collar is for single use only.

The Healing Screw is used to seal the implant internal connection and separate it from the soft tissue which is sutured over the implant during healing.

The Retaining Screws are intended to be used for securing the temporary abutments, final abutments and impression transfers to the implant or implant analog. The long Retaining Screw is intended to be used with Temporary Abutments for fabrication of screw-retained provisional restorations and with Impression Transfers for direct impressions.

Device Description

The Zimmer 3.1mmD Dental Implant System consists of 3.1mm threaded endosseous dental implants, as well as prosthetic components, and ancillary components for placement and restoration of these implants. The prosthetic components include 2.9mm Angled Abutment, 2.9mm Angled Abutment, Straight Hex, 2.9mm Contour Abutment, 2.9mm Contour Abutment, Straight Hex , 2.9mm Temporary Abutment, and 2.9mm Ball Abutment. The 2.9mm Angled, 2.9mm Contour, and 2.9mm Temporary Abutments are made to support single or multiple unit restorations. The 2.9mm Ball Abutments are made to support overdentures. The ancillary components for the Zimmer 3.1mmD Dental Implant System include 2.9mm Healing Collars and 2.9mm Healing Screws which are used during the healing process.

Zimmer 3.1mmD Dental Implant is an endosseous dental implant composed of titanium alloy. The implant body is designed for ease of implantation and with greater surface area for osseointegration. The implant surface is treated to facilitate osseointegration. In addition, the implant body is tapered with triple-lead threads. The Zimmer Dental 3.1mmD Dental Implant is currently offered in 3.1mm diameter in lengths of 8, 10, 11.5, 13, and 16mm. They include two different texturing configurations: full texture to the top of the implant and texture to 0.5mm from the top of the implant. In addition, both texturing configurations of the implant have coronal grooves on the collar to within 0.64mm of the top of the implant similar to the predicate #1: Tapered Screw-Vent Implant Dental Implant. The implant-abutment interface platform diameter will be offered in a size of 2.9mm. The new device will feature MTX surface equivalent to existing Zimmer Dental implants.

The Abutments, Healing Collars, and Healing Screw are titanium alloy devices that are made to mate with the Zimmer 3.1mmD Dental Implant, which is also made of titanium alloy. The abutments are designed for use as a terminal or intermediate abutment prostheses.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the Zimmer 3.1mmD Dental Implant System. It describes a medical device, not a diagnostic AI system, therefore most of the requested information regarding AI study design and performance metrics is not applicable.

However, I can extract the relevant information about the non-clinical testing performed to establish substantial equivalence.

Acceptance Criteria and Device Performance for Zimmer 3.1mmD Dental Implant System

The Zimmer 3.1mmD Dental Implant System is evaluated based on non-clinical testing to demonstrate substantial equivalence to predicate devices, focusing on mechanical performance and MRI compatibility.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that non-clinical testing indicates the new devices are "strong enough to withstand the anticipated forces and demonstrated improvements over the predicate device(s)." It also confirms that the device "poses no additional restrictions on MRI beyond those that would otherwise occur for the patient."

While specific numerical acceptance criteria (e.g., minimum fatigue strength in MPa or compression load in N) and exact reported device performance values are not explicitly provided in this summary, the general acceptance criteria can be inferred from the nature of the tests and the conclusions drawn:

Acceptance Criterion (Inferred from Test Objective)	Reported Device Performance (Summary)
Mechanical Strength & Durability:
Withstand anticipated forces without failure	"strong enough to withstand the anticipated forces"
Demonstrate improvement over predicate device(s)	"demonstrated improvements over the predicate device(s)"
MRI Safety & Compatibility:
No additional restrictions on MRI for the patient	"poses no additional restrictions on MRI beyond those that would otherwise occur for the patient"

2. Sample Size and Data Provenance for the Test Set

Sample Size for Test Set: The document does not specify the sample size used for the fatigue, compression, or MRI compatibility tests. It only states "Non-clinical test data was used."
Data Provenance: The tests were non-clinical, meaning they were likely conducted in a laboratory setting by Zimmer Dental Inc. The country of origin for the data is not specified, but the applicant information is for Zimmer Dental Inc. in Carlsbad, CA, USA. The data is prospective, as it involves testing of the new device.

3. Number of Experts and Qualifications for Ground Truth

This is not applicable as the device is a dental implant system being evaluated through non-clinical mechanical and physical property testing, not an AI diagnostic device requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

This is not applicable, as the evaluation is based on objective measurements from mechanical and physical testing, not subjective expert judgment, which would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This is not applicable. The document describes a medical device (dental implant and associated components), not a diagnostic AI system. Therefore, no MRMC study testing human reader improvement with or without AI assistance was performed.

6. Standalone (Algorithm Only) Performance Study

This is not applicable. The device is a physical dental implant system, not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device is based on objective measurements derived from standardized non-clinical performance tests conforming to FDA guidance and ASTM standards. Specifically:

Mechanical Integrity: Measured by fatigue and compression testing results.
MRI Compatibility: Measured by interactions with magnetic fields during MRI.

8. Sample Size for the Training Set

This is not applicable. The product is a physical device, not an AI model, and therefore does not have a "training set" in the context of machine learning.

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

This is not applicable, as there is no training set for an AI model.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol of three stylized human profiles facing right. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

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

October 28, 2014

Zimmer Dental, Inc. Christina Boydston Quality Manager 1900 Aston Ave. Carlsbad. California 92008-7308

Re: K142082

Trade/Device Name: Zimmer 3.1mmD Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: July 28, 2014 Received: July 31, 2014

Dear Ms. Boydston,

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

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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-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 I. 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/2 description: The image shows the logo for Zimmer Dental. The logo features a large, light blue letter Z in a circular shape. Below the letter Z, the word "zimmer" is written in a smaller, sans-serif font, and below that, the word "dental" is written in an even smaller font.

Indications for Use

K142082 510(k) Number (if known):

Device Name: Zimmer 3.1mmD Dental Implant System

Indications For Use:

The Ball Abutment is used for retaining overdentures or partial dentures when resilience and facilitated oral hygiene are desired.

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The Healing Collar is used to assist in the forming of the soft tissue during healing before a final restoration is placed. The Healing Collar is for single use only.

The Healing Screw is used to seal the implant internal connection and separate it from the soft tissue which is sutured over the implant during healing.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Page 17 of 997
Zimmer Dental 900 Aston Avenue arlsbad, CA 92008 60.929.4300 (ph) 60.431.7811 (fax)

Traditional 510(k) PRE-MARKET NOTIFICATION 510(k)

510(k) SUMMARY (21CFR807.92(a))

Submitter's Information: 1.

Name:	Zimmer Dental Inc.
Address:	1900 Aston Ave.
	Carlsbad, CA 92008
Phone:	760-929-4150
Contact:	Christina Boydston
Date Prepared:	July 28, 2014

1. Device Name:
  Trade Name: Regulation Number: Classification Code: Device Classification Name:

Trade Name: Regulation Number: Classification Code: Device Classification Name:

Trade Name: Regulation Number: Classification Code: Device Classification Name: Zimmer 3.1mmD Dental Implant 872.3640 DZE Implant, Endosseous, Root-Form

2.9mm Angled Abutment 872.3630 NHA Abutment, Implant, Dental, Endosseous

2.9mm Angled Abutment, Straight Hex 872.3630 NHA Abutment, Implant, Dental, Endosseous

2.9mm Contour Abutment 872.3630 NHA Abutment, Implant, Dental, Endosseous

2.9mm Contour Abutment, Straight Hex 872.3630 NHA Abutment, Implant, Dental, Endosseous

2.9mm Temporary Abutment 872.3630 NHA Abutment, Implant, Dental, Endosseous

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Trade Name: Regulation Number: Classification Code: Device Classification Name:

3. Predicate Device(s):

Predicate Device No. 1 Trade Name: 510(k):

Regulation Number: Classification Code: Device Classification Name:

Predicate Device No. 2 Trade Name: 510(k): Regulation Number: Classification Code: Device Classification Name:

Predicate Device No. 3 Trade Name: 510(k): Regulation Number: Classification Code: Device Classification Name:

Predicate Device No. 4 Trade Name: 510(k): Regulation Number: Classification Code: Device Classification Name: 2.9mm Ball Abutment 872.3630 NHA Abutment, Implant, Dental, Endosseous

2.9mm Healing Collar 872.3630 NHA Abutment, Implant, Dental, Endosseous

2.9mm Healing Screw 872.3630 NHA Abutment, Implant, Dental, Endosseous

Tapered Screw-Vent Implant K011028, K013227, K061410, K072589, K101977, K111889 872.3640 DZE Implant, Endosseous, Root-Form

Screw-Vent Dental Implant K011028, K013227, K061410 872.3640 DZE Implant, Endosseous, Root-Form

Ospol Dental Implant System K070184 872.3640 DZE Implant, Endosseous, Root-Form

Zimmer Dental Inc. 20° Angled Abutment K011028 872.3630 NHA Implant, Endosseous, Root-Form

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Predicate Device No. 5 Trade Name: 510(k): Regulation Number: Classification Code: Device Classification Name:

Predicate Device No. 6 Trade Name: 510(k): Regulation Number: Classification Code: Device Classification Name:

Predicate Device No. 7 Trade Name: 510(k): Regulation Number: Classification Code: Device Classification Name:

Predicate Device No. 8 Trade Name: 510(k): Regulation Number: Classification Code: Device Classification Name:

Predicate Device No. 9 Trade Name: 510(k): Regulation Number: Classification Code: Device Classification Name: Zimmer Dental Inc. 3.5mm Hex-Lock Abutment K052600 872.3630 NHA Implant, Endosseous, Root-Form

Zimmer Dental Inc. Temporary Plastic Abutment K092377 872.3630 NHA Implant, Endosseous, Root-Form

Zimmer Dental Inc. Screw-Vent Ball Abutment K011028 872.3630 NHA Implant, Endosseous, Root-Form

Zimmer Dental TSV Healing Collars K11852 872.3630 NHA Implant, Endosseous, Root-Form

Zimmer Dental Surgical Cover Screw K011028 872.3630 NHA Implant, Endosseous, Root-Form

4. Device Description:

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support single or multiple unit restorations. The 2.9mm Ball Abutments are made to support overdentures. The ancillary components for the Zimmer 3.1mmD Dental Implant System include 2.9mm Healing Collars and 2.9mm Healing Screws which are used during the healing process.

ನ. Indications for Use:

The 2.9mm Angled Abutment and the 2.9mm Angled Abutment, Straight Hex and are used for attachment of restorations requiring off-axis correction. The 2.9mm Angled Abutment and the 2.9mm Angled Abutment, Straight Hex are designed to be used in edentulous or partially edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a freestanding single tooth replacement.

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The 2.9mm Contour Abutment and the 2.9mm Contour Abutment, Straight Hex are used as a terminal or intermediate abutment for a cemented prosthesis. Abutment can be used for a single- or multiple-unit restoration. The 2.9mm Angled Contour Abutment and the 2.9mm Angled Contour Abutment, Straight Hex are designed to be used as a terminal or intermediate abutment for a cemented prosthesis where the angle needs to be offset by 17°. Abutment can be used for a single- or multiple-unit restoration.

The 2.9mm Temporary Abutment is intended to be used to fabricate and support provisional restorations that aid in creating an esthetic emergence through the gingiva during the healing period and prior to final restoration. The 2.9mm Temporary Abutment can be used for cement-retained or screw-retained provisional restorations. The abutments can be used for single-unit and multiunit restorations.

The Ball Abutment is used for retaining overdentures or partial dentures when resilience and facilitated oral hygiene are desired.

The Healing Collar is used to assist in the forming of the soft tissue during healing before a final restoration is placed. The Healing Collar is for single use only.

The Healing Screw is used to seal the implant internal connection and separate it from the soft tissue which is sutured over the implant during healing.

Device Comparison:

Zimmer Dental believes the new devices presented in the Zimmer 3.1mmD Dental Implant System to be substantially equivalent to their respective predicate. Furthermore, Zimmer Dental believes the Zimmer 3.1mmD Dental Implant system to be substantially equivalent to the previously cleared Tapered Screw Vent and Screw Vent Implant Systems originally cleared in K011028, K013227, K061410, K072589, K101977, and K111889. The new Zimmer 3.1mmD Dental Implant System is substantially equivalent to predicates devices relative to material, general design features, as well as design and manufacturing process. The differences are the implant/abutment interface, platform sizes and the implant diameter which are similar to predicate device 2 and predicate device 3.

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6. Technological Characteristics

Table 1: General Implant Device Comparison

	New Device 1	Predicate 1	Predicate 2	Predicate 3
Feature	Zimmer 3.1mmDImplant	Tapered Screw-VentImplant	Screw-VentDental Implant	Ospol DentalImplant System
ImplantInterface	Internal HexConical Connection	Internal Hex	Internal Hex	ConicalConnection
Lengths	8mm, 10mm,11.5mm, 13mm,16mm	8mm, 10mm, 11.5mm,13mm, 16mm	8mm, 10mm,13mm, 16mm	8.0mm, 10mm,12mm 15.0mm
Diameters	3.1mm	3.7 mm, 4.1 mm,4.7mm, 6.0mm	3.3mm,3.7mm, 4.7mm	4.0mm
Material	Titanium 6Al-4VELI	Titanium 6Al-4V ELI	Titanium 6Al-4V ELI	CommerciallyPure Titanium
Collars	Machined surfaceand texture, withgroovesorTexture to the topwith grooves	Machined Surface andTextureorMachined surface andtexture, with groovesorTexture to the top withgrooves	MachinedSurface andTexture	Ospol SurfaceTexturing(Oxidized + Ca+2)
Thread Pattern	Triple lead threads	Triple lead threads	Single Lead	Single Lead
SurfaceCharacteristics	MTX Surface	MTX Surface and MP-1 HA	MTX Surfaceand MP-1 HA	Ospol SurfaceTexturing(Oxidized + Ca+2)

Table 2: General Prosthetic Device Comparison

Feature	New Device 2	Predicate 4
	2.9mm Angled Abutment	Zimmer Dental Inc. 20° Angled Abutment
Implant/AbutmentInterface	Internal Hex, Friction fitConical Connection, Friction fit	Internal Hex, Friction fit
Abutment Angles	20°	20°
Platform Diameter	2.9mm	3.5mm, 4.5mm, 5.7mm
Material	Titanium 6Al-4V ELI	Titanium 6Al-4V ELI
Method of Attachment	Retaining screw	Retaining screw
Feature	New Device 32.9mm Angled Abutment,Straight Hex	Predicate4Zimmer Dental Inc. 20° Angled Abutment
Implant/AbutmentInterface	Straight Internal HexConical Connection, Friction fit	Internal Hex, Friction fit
Abutment Angles	20°	20°
Platform Diameter	2.9mm	3.5mm, 4.5mm, 5.7mm
Material	Titanium 6Al-4V ELI	Titanium 6Al-4V ELI
Method of Attachment	Retaining screw	Retaining screw
Feature	New Device 42.9mm Contour Abutment	Predicate 5Zimmer Dental Inc. 3.5mm Hex-LockAbutment
Implant/AbutmentInterface	Internal Hex, Friction fitConical Connection, Friction fit	Internal Hex, Friction fit
Abutment Angles	Straight 17°	Straight 17°

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Platform Diameter	2.9mm	3.5mm, 4.5mm, 5.7mm
Material	Titanium 6Al-4V ELI	Titanium 6Al-4V ELI
Method of Attachment	Retaining screw	Retaining screw
	New Device 5		Predicate 5
Feature	2.9mm Contour Abutment,Straight Hex		Zimmer Dental Inc. 3.5mm Hex-LockAbutment
Implant/AbutmentInterface	Straight Internal HexConical Connection, Friction fit		Internal Hex, Friction fit
Abutment Angles	Straight, 17°	Straight, 17°
Platform Diameter	2.9mm	3.5mm, 4.5mm, 5.7mm
Material	Titanium 6Al-4V ELI	Titanium 6Al-4V ELI
Method of Attachment	Retaining screw	Retaining screw
	New Device 6	Predicate 6	Predicate 5
Feature	2.9mm Temporary Abutment	Zimmer Dental Inc.Temporary PlasticAbutment	Zimmer Dental Inc.3.5mm Hex-LockAbutment, Straight
Implant/AbutmentInterface	Straight Internal HexConical Connection, Friction fit	Internal hex	Internal hex,Friction fit
Abutment Angles	Straight	Straight, 17°	Straight
Platform Diameter	2.9mm	3.5mm, 4.5mm,5.7mm	3.5mm, 4.5mm,5.7mm
Material	Titanium 6Al-4V ELI	PEEK-CLASSIX™	Titanium 6Al-4V ELI
Method of Attachment	Retaining screw	Retaining screw	Retaining screw
	New Device 7		Predicate 7
Feature	2.9mm Ball Abutment		Zimmer Dental Inc. Screw Vent BallAbutment
Implant/AbutmentInterface	Internal Threading	Internal Threading
Platform Diameter	2.9mm	3.5mm, 4.5mm, 5.7mm
Material	Titanium 6Al-4V ELI	Titanium 6Al-4V ELI
Method of Attachment	Ball abutment threads intoimplant		Ball abutment threads into implant

Table 3: General Ancillary Device Comparison

Feature	New Device 82.9mm Healing Collars	Predicate 8Zimmer Dental TSV HealingCollars
Implant/AbutmentInterface	Internal Threading	Internal Threading
Platform Diameter	2.9mm	3.5mm, 4.5mm, 5.7mm
Material	Titanium 6Al-4V ELI	Titanium 6Al-4V ELI
Method of Attachment	Healing collar threads into implant	Healing collar threads into implant
Feature	New Device 92.9mm Healing Screw	Predicate 9Surgical Cover Screw, Titanium
Implant/AbutmentInterface	Internal Threading	Internal Threading
Platform Diameter	2.9mm	3.5mm, 4.5mm, 5.7mm
Material	Titanium 6Al-4V ELI	Titanium 6Al-4V ELI
Method of Attachment	Healing screw threads into implant	Healing screw threads into implant

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7. Non-Clinical Testing:

Non-clinical test data was used to support the decision of substantial equivalence. Non-clinical testing consisted of performance of fatigue and compression testing in accordance with the FDA guidance Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments. The testing indicates that the new devices are strong enough to withstand the anticipated forces and demonstrated improvements over the predicate device(s).

Additionally, Zimmer Dental implant systems were evaluated for interactions with magnetic fields during Magnetic Resonance Imaging (MRI) in accordance with the FDA Guidance: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment and ASTM F 2182: Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants during Magnetic Resonance Imaging. This was done to determine the presence of the dental implant or abutment poses no additional restrictions on MRI beyond those that would otherwise occur for the patient.

8. Clinical Testing:

No clinical testing was performed. Non-clinical testing was used to support the decision of substantial equivalence.

Conclusion: 9.
Based on our analysis, the devices are substantially equivalent to their predicates.

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.