Narrow implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another. MIS short implants are to be used only with straight abutments.

Device Description

The proposed MIS Dental Implant System entails a material modification and line extension of the MIS Lance+ Internal Hex Dental Implants and new offering of MIS Internal Hex Cobalt Chrome Abutments.

Lance+ Dental Implants: A modification and line extension to the originally cleared Lance implants (K040807). Manufactured from titanium alloy, Ti- 6Al-4V ELI, compared to the prior CP titanium grade 4. Additional sizes are being added as a line extension.

MIS Internal Hex Cobalt Chrome (CoCr) abutments: Pre-manufactured prosthetic components directly connected to the endosseous dental implant and intended for use as an aid in prosthetic rehabilitation. Intended for permanent restoration for single tooth or multiple units screw retained restorations. The lower part of the abutment is made of CoCr alloy, and the upper part is made of plastic (POM). The plastic part is dissolved during the casting process. The abutment is connected to the implant by a prosthetic screw.

AI/ML Overview

This document is a 510(k) Pre-market Notification for the MIS Dental Implant System. It describes the device, its intended use, and comparative studies to establish substantial equivalence to previously cleared devices, rather than a study proving performance against acceptance criteria for a novel AI/software device. Therefore, much of the requested information regarding AI device acceptance criteria and study design is not applicable or cannot be extracted from this document.

However, I can extract the information related to the device's technical performance and the non-clinical studies conducted.

Here's a breakdown of the relevant information:

1. Table of acceptance criteria and the reported device performance:

Since this is not an AI/software device, there aren't traditional "acceptance criteria" for metrics like sensitivity, specificity, or accuracy. Instead, the acceptance criteria relate to engineering and biocompatibility standards. The reported device performance is demonstrated by meeting these standards.

Acceptance Criteria (Standard / Test)	Reported Device Performance
Fatigue Testing (ISO 14801:2016)	Withstood 5,000,000 cycles without failure at a substantially equivalent load to predicate/reference devices.
CoCr Corrosion Testing	Very low corrosion rates, with the lowest rate for CoCr-titanium couple; low risk of galvanic corrosion.
Biocompatibility Testing (Cytotoxicity)	Results supported a conclusion of non-cytotoxicity for the CoCr abutments. (Implants made of same material as predicate, so no new testing needed).
Surface Treatment Characterization	Identical to predicate device implants (K180282) and reference device implants (K040807), characterized with reference to May 2004 FDA Guidance.
Packaging Integrity (ISO 11607-1:2009 & ASTM F1929-12)	Validation of package integrity over the specified shelf life supports the specified shelf-life.
Sterilization Validation (Radiation - ANSI/AAMI/ISO 11137-1 & 11137-2)	Supports a minimum sterility assurance level (SAL) of 10^-6 for dental implants.
Sterilization Validation (Moist Heat - ANSI/AAMI/ISO 17665-1 & 17665-2)	Supports a minimum sterility assurance level (SAL) of 10^-6 for abutments.

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

Sample Size for Test Set: The document does not specify a distinct "test set" in the context of an AI/software device. For the non-clinical performance tests like fatigue and corrosion, the sample sizes are determined by the respective ISO/ASTM standards. These details are not provided in this summary.
Data Provenance: Not applicable in the context of clinical data for an AI/software device. The non-clinical testing was conducted by MIS Implants Technologies.

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

Not Applicable. This is a medical device (dental implant and abutments), not an AI/software device that relies on expert interpretation for ground truth.

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

Not Applicable. See point 3.

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:

No. This is not an AI-assisted device.

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

Not Applicable. This is a physical medical device.

7. The type of ground truth used:

Defined by Engineering Standards and Material Properties: The "truth" for this device is its adherence to mechanical performance standards (e.g., fatigue strength), biocompatibility (e.g., non-cytotoxicity, corrosion resistance), and physical characteristics (e.g., dimensions, material composition). This is established through laboratory testing following ISO and ASTM guidelines.

8. The sample size for the training set:

Not Applicable. There is no "training set" as this is not an AI/software device.

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

Not Applicable. See point 8.

Summary of applicable information from the document:

This 510(k) summary focuses on demonstrating the substantial equivalence of the modified MIS Dental Implant System (Lance+ Internal Hex Implants and Cobalt Chrome Abutments) to existing legally marketed predicate devices. The evidence presented primarily consists of non-clinical performance data:

Fatigue testing: Conducted according to ISO 14801:2016 for the implants.
Corrosion testing: For the Cobalt Chrome (CoCr) abutments, indicating low risk of galvanic corrosion when coupled with titanium.
Biocompatibility testing: Cytotoxicity testing for the CoCr abutments, with implants relying on prior testing for the same materials.
Surface treatment characterization: Confirmed to be identical to predicate devices.
Packaging integrity validation: Conducted per ISO 11607-1:2009 and ASTM F1929-12.
Sterilization validation: For both radiation (implants) and moist heat (abutments), adhering to relevant ANSI/AAMI/ISO standards to achieve an SAL of 10^-6.

The document explicitly states: "No human clinical data were included to support substantial equivalence." This means the device relies entirely on non-clinical engineering and material science data to prove its safety and effectiveness relative to existing, cleared devices.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 11, 2019

Dentsply Sirona Inc. Karl Nittinger Vice President, Regulatory Affairs 221 West Philadelphia Street Suite 60W York, Pennsylvania 17401

Re: K192149

Trade/Device Name: MIS Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: September 12, 2019 Received: September 13, 2019

Dear Karl Nittinger:

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.

{1}------------------------------------------------

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 mediation-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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K192149

Device Name MIS Dental Implant System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Permitting Use (Part 21 CFR 601 Subpart E)
Over-The-Counter Use (21 CFR 201.66)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401

Image /page/3/Picture/2 description: The image shows the logo for Dentsply Sirona. The logo consists of a stylized leaf-like shape on the left, followed by the text "Dentsply" on the top line and "Sirona" on the bottom line. The text is in a simple, sans-serif font and is a dark gray color.

510(k) SUMMARY For: K192149 MIS Dental Implant System

1. Submitter Information:

Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401

Contact Name:	Karl Nittinger, Vice President, Corporate Regulatory Affairs
Telephone Number:	717-849-4424
Fax Number:	717-849-4343

Date Prepared: November 19, 2019

2. Device Identification:

Trade/Proprietary Name: MIS Dental Implant System

Classification Name:	Endosseous dental implant
Regulation Number:	872.3640
Primary Product Code:	DZE
Secondary Product Code:	NHA
Device Class:	Class II
Classification Panel:	Dental Devices Panel

3. Predicate and Reference Devices

The predicate and reference devices that have been identified relating to the substantial equivalence of the proposed MIS Dental Implant System entailing a material modification and line extension of the MIS Lance+ Internal Hex Dental Implants and new offering of MIS Internal Hex Cobalt Chrome Abutments are:

Primary Predicate Device	510(k)	Manufacturer
Implants- MIS Internal HexDental Implant System	K180282	MIS Implants Technologies Ltd.
Reference Devices	510(k)	Manufacturer
Implants and Abutments- MISDental Implant System	K040807	MIS Implants Technologies Ltd.
Abutments- Dentum Implantium/SuperLine Prosthetics	K160828	Dentium Co., Ltd.

{4}------------------------------------------------

4. Device Description

Table 5.1 describes the proposed devices and their detailed modifications from their originally cleared 510(k) notifications.

Table 5.1
Proposed Device	Proposed Modifications
Lance+ Internal Hex Implant System	Change material from originally cleared CP Titanium grade 4 to titanium alloy. Add the following implant diameter, length, platform combinations: 3.75 mm (DIA) x 8 mm (L), standard platform 4.20 mm (DIA) x 8 mm (L), standard platform 5.00 mm (DIA) x 8 mm (L), wide platform 6.00 mm (DIA) x 8 mm (L), wide platform 6.00 mm (DIA) x 10 mm (L), wide platform 6.00 mm (DIA) x 11.5 mm (L), wide platform 6.00 mm (DIA) x 13 mm (L), wide platform 3.30 mm (DIA) x 10 mm (L), narrow platform 3.30 mm (DIA) x 11.5 mm (L), narrow platform 3.30 mm (DIA) x 13 mm (L), narrow platform 3.30 mm (DIA) x 16 mm (L), narrow platform
MIS Internal Hex abutments	Add abutments in new material (CoCr) offered. 4.3 mm (DIA), narrow platform, anti-rotation 4.3 mm (DIA), narrow platform, free-rotation 5.0 mm (DIA), standard platform, anti-rotation 5.0 mm (DIA), standard platform, free-rotation 5.5 mm (DIA), wide platform, anti-rotation 5.5 mm (DIA), wide platform, free-rotation 4.8 mm (DIA), multi-unit, free rotation Post-casting specifications: 0° angulation for straight implantation only. 0.5 mm minimum wall thickness. 4 mm minimum post height. 1 mm minimum gingival collar

Lance+ Dental Implants – The proposed MIS Lance+ Internal Hex implants are a modification and line extension to the originally cleared Lance implants (K040807). The proposed Lance+ implants are manufactured from titanium alloy, Ti- 6Al-4V ELI complying with standard ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant compared to the prior CP titanium grade 4. Apart from the change in material, additional sizes are being added as a line extension. Table 5.1 above summarizes the modifications being made. Both the subject Lance+ Internal Hex Implants and the originally cleared Lance implants (K040807) have identical intended use and similar indications for use.

{5}------------------------------------------------

MIS Internal Hex Cobalt Chrome (CoCr) abutments – The proposed MIS Internal Hex CoCr abutments are pre-manufactured prosthetic components directly connected to the endosseous dental implant and intended for use as an aid in prosthetic rehabilitation. They are intended for permanent restoration for single tooth or multiple units screw retained restorations. The lower part of the abutment, which connects directly to the implant, is made of CoCr alloy, and the upper part is made of plastic (POM). The plastic part is dissolved during the casting process. The abutment is connected to the implant by a prosthetic screw, supplied with the abutment.

5. Indications for Use

MIS Dental Implant Systems are 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 masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate. Narrow implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another. MIS short implants are to be used only with straight abutments.

6. Substantial Equivalence Discussion

MIS Lance+ Internal Hex implants:

For the purposes of substantial equivalence, the proposed MIS Lance+ Internal Hex Implants are compared to the predicate device MIS Internal Hex Implant System (K180282) and the originally cleared predicate MIS Dental Implant System (K040807-includes originally cleared Lance implants). The comparison table below (Table 5.2) summarizes the proposed implants to the predicate devices with respect to indications for use, principles of operation, technological characteristics, and performance testing to demonstrate that the data provided for the proposed implants supports equivalence to the predicate devices.

{6}------------------------------------------------

Table 5.2- Comparison of Implant Characteristics – Proposed MIS Lance+ Internal Hex implants and the predicate devices:

Trade Name	MIS Dental Implant System(Lance+ Internal Hex Implants)	MIS Internal Hex Dental ImplantSystemK180282
Indicationsfor use:	MIS dental implant systems areintended to be surgically placed inthe bone of the upper or lower jawarches to provide support forprosthetic devices, such as artificialteeth, in order to restoremasticatory function. When a one-stage surgical procedure is applied,the implant may be immediatelyloaded when good primary stabilityis achieved and the occlusal load isappropriate.Narrow implants (Ø3.3mm) areindicated for use in surgical andrestorative applications forplacement only in the mandibular	MIS dental implant systems areintended to be surgically placed in thebone of the upper or lower jaw archesto provide support for prostheticdevices, such as artificial teeth, inorder to restore masticatory function.When a one-stage surgical procedureis applied, the implant may beimmediately loaded when goodprimary stability is achieved and theocclusal load is appropriate.Narrow implants (Ø3.3mm & UNO)are indicated for use in surgical andrestorative applications for placementonly in the mandibular central, lateralincisor and maxillary lateral incisor

central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another. MIS short implants are to be used only with straight abutments.

Proposed Device

regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another. The long MIS (18 & 20 mm) implants can be used in a tilted manner. MIS short implants are to be used only with straight abutments. M4 short implants are indicated for delayed loading only.

Predicate Device

The MIS dental implant system is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.

Reference Device

MIS Dental Implant System (includes originally cleared Lance implants) K040807

Similarities/Differences

Identical to predicate device K180282 with the exception of the reference in the predicate device (K180282) indications for use to the short M4 implants and UNO Narrow implants and to 18 mm and 20 mm length implants. The M4 and UNO implant variants, as well as the 18 mm and 20 mm length MIS implants are not within the scope of the offerings of the proposed device.

{7}------------------------------------------------

Table 5.2- Comparison of Implant Characteristics - Proposed MIS Lance+ Internal Hex implants and the predicate devices:
Trade Name	Proposed DeviceMIS Dental Implant System(Lance+ Internal Hex Implants)	Predicate DeviceMIS Internal Hex Dental ImplantSystemK180282	Reference DeviceMIS Dental Implant System(includes originally clearedLance implants)K040807	Similarities/Differences
EndosseousImplantMaterial(s)	Ti-6Al-4V ELI per ASTM F136	Ti-6Al-4V ELI per ASTM F136	CP Titanium grade 4	Identical to predicate device K180282.
SurfaceTreatment	Sand blasted and acid etched	Sand blasted and acid etched	Sand blasted and acidetched	No Difference
ConnectionType	Internal hexagon	Internal hexagon	Internal hexagon	No difference
Body design	Tapered, conical shape, threaded	Tapered, conical shape, threaded	Tapered, conical shape,threaded	No difference.
Neck Design	Cylindrical, no micro-rings	Cylindrical, with micro-rings (SevenImplants) and Cylinder (M4 Implants)	Cylindrical, no micro-rings	No difference from the predicate device K040807.
Apex	Domed	Domed (Seven Implants) and Flat (M4Implants)	Domed	No difference. Domed apex configuration offered inpredicate device K180282 and K040807.
Thread	Triple	Dual	Triple	No difference from the predicate device K040807.
Type ofimplant	Bone level implant	Bone level implant	Bone level implant	No difference.
Implantplatform	Standard Platform (SP), WidePlatform (WP), Narrow Platform(NP)	SP, WP, NP	SP, WP	Identical to platform offerings of predicate deviceK180282.
ImplantDiameters	SP: Ø 3.75 mm, 4.20 mmWP: Ø 5.00 mm, 6.00 mmNP: Ø 3.30 mm	SP: Ø 3.75 mm, 4.20 mmWP: Ø 5.00 mm, 6.00 mmNP: Ø 3.30 mm	SP: Ø 3.75 mm, 4.20 mmWP: Ø 5.00 mm	Identical to the platform offerings of predicatedevice K180282.
ImplantLengths	8, 10, 11.5, 13, 16 mm	8, 10, 11.5, 13, 16, 18, 20 mm	10, 11.5, 13, 16 mm	Length range offering is within the range of thepredicate devices.
SterilizationMethod	Radiation	Radiation	Radiation	No differences.

{8}------------------------------------------------

MIS Internal Hex Cobalt Chrome (CoCr) abutments

The proposed MIS Internal Hex CoCr abutments are compared to the abutment offereing their predicate and reference devices with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing (see Table 5.3).

Geometrically, these abutments are identical to the predicate MIS Internal Hex Gold abutments (K180282) but differ in terms of material. The difference in material of the proposed abutments is accounted for by comparing to the material used for the reference device of Dentum Implantium/SuperLine Prosthetics (K160828). Both the proposed MIS Internal Hex CoCr abutments and the predicate MIS Internal Hex Gold abutments (K180282) are provided in all three platforms, and either have a free-rotation or an antirotation configuration. The intended use and indications for use are the same, as well as the gingival height, and the indication for 0 degree angulation for straight implantation only. Both the proposed MIS Internal Hex CoCr abutments and the predicate MIS Internal Hex Gold abutments (K180282) connect directly to the implant in the same internal hex connection, and are provided non sterile, to be sterilized by the user. The main difference is the composition of a new material, which is provided by the reference device (K160828), having the same intended use and similar indications for use. Furthermore, testing in the form of cytotoxicity tests and corrosion tests are provided to support equivalence to the predicate and reference devices.

Table 5.3- Comparison of abutment Characteristics - proposed MIS Internal Hex CoCr abutments and predicate/reference devices:

	Proposed Device	Predicate Device	Reference Device
Trade Name	MIS Dental Implant System(Internal Hex Cobalt Chrome Abutments)	MIS internal Hex Gold AbutmentsK180282	Dentum Implantium/ SuperLineProstheticsK160828
Indicationsfor use	MIS dental implant systems are intendedto be surgically placed in the bone of theupper or lower jaw arches to providesupport for prosthetic devices, such asartificial teeth, in order to restoremasticatory function. When a one-stagesurgical procedure is applied, the implantmay be immediately loaded when goodprimary stability is achieved and theocclusal load is appropriate.Narrow implants ( $\text{\O}3.3$ mm) are indicatedfor use in surgical and restorativeapplications for placement only in themandibular central, lateral incisor andmaxillary lateral incisor regions of partiallyedentulous jaws, to provide support forprosthetic devices such as artificial teeth.Mandibular central and lateral incisorsmust be splinted if using two or morenarrow implants adjacent to one another.MIS short implants are to be used onlywith straight abutments.	MIS dental implant systems are intended tobe surgically placed in the bone of the upperor lower jaw arches to provide support forprosthetic devices, such as artificial teeth, inorder to restore masticatory function. When aone-stage surgical procedure is applied, theimplant may be immediately loaded whengood primary stability is achieved and theocclusal load is appropriate.Narrow implants ( $\text{\O}3.3$ mm & UNO) areindicated for use in surgical and restorativeapplications for placement only in themandibular central, lateral incisor andmaxillary lateral incisor regions of partiallyedentulous jaws, to provide support forprosthetic devices such as artificial teeth.Mandibular central and lateral incisors mustbe splinted if using two or more narrowimplants adjacent to one another. The longMIS (18 & 20 mm) implants can be used in atilted manner. MIS short implants are to beused only with straight abutments. MIS M4short implants are indicated for delayedloading only.	Dentium Implantium & SuperLineProsthetics are intended for use asan aid in prosthetic rehabilitation.

{9}------------------------------------------------

Table 5.3- Comparison of abutment Characteristics - proposed MIS Internal Hex CoCr abutments and
predicate/reference devices:
Trade Name	Proposed DeviceMIS Dental Implant System(Internal Hex Cobalt Chrome Abutments)	Predicate DeviceMIS internal Hex Gold AbutmentsK180282	Reference DeviceDentum Implantium/ SuperLineProstheticsK160828
Material(s)	Abutment base:Cobalt-Chromium alloyPlastic cylinder: Polyoxymethylene (POM)Prosthetic screw:Ti 6Al 4V ELI per ASTM F136	Abutment base:Gold alloy.Plastic cylinder: Polyoxymethylene (POM)Prosthetic screw:Ti 6Al 4V ELI per ASTM F136	Abutment base: Cobalt-ChromiumalloyPlastic cylinder: unknown
ConnectionType	Internal hexagon	Internal hexagon	Conical hex
Angulation	0°	0°	0°
Sterilization	Product provided non-sterile	Product provided non-sterile	Product provided non-sterile

7. Non-Clinical Performance Data

As part of demonstrating the substantial equivalence of the proposed MIS Lance+ Dental implant System and the proposed MIS Internal Hex CoCr abutments to the predicate and reference devices, MIS Implants Technologies completed a number of non-clinical performance tests:

. Fatigue Testing - Mechanical testing of the proposed MIS Lance+ Internal Hex implants in accordance to ISO 14801:2016 was conducted. The test articles were able to withstand 5,000,000 cycles without failure at a substantially equivalent load to the cited predicate and reference device.
. CoCr corrosion testing - All tested dental metal alloys have very low corrosion rates, with the lowest corrosion rate achieved for the CoCr-titanium couple, indicating that in physiological conditions the CoCr presents low risk of galvanic corrosion when coupled with titanium. The test establishes the proposed MIS Internal Hex CoCr abutments as having no risk for corrosion.
. Biocompatibility Testing- The proposed MIS Lance+ Internal Hex Implants are made from the same materials, under the same processing conditions and at the same manufacturing location as the predicate device, MIS Internal Hex Dental Implants (K180282). Therefore, no further biocompatibility testing was conducted in support of substantial equivalence. Biocompatibility testing (cytotoxicity) was conducted on the proposed MIS Internal Hex CoCr Abutments and results supported a conclusion non-cytotoxicity.
Surface treatment of the proposed implants is identical to the surface treatment of the predicate device implants cleared under K180282 and the reference device implants cleared under K040807. Characterization of the surface treatment is provided with reference to the May, 2004, Guidance for Industry an FDA Staff: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.
. Packaging configuration of the proposed dental implants, which are provided sterile, is identical to the predicate devices cleared under K180282. Validation of package integrity over the specified shelf life has been conducted according to methods described in ISO 11607-1:2009 (Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile

{10}------------------------------------------------

barrier systems and packaging systems) and ASTM F1929-12 (Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration). Results of the shelf-life validation of the package configuration support the specified shelf-life.

Sterilization validation has been conducted on the gamma irradiation process utilized to sterilize the proposed dental implants which are provided sterile to the end user and on the steam sterilization process for the proposed abutments which are provided non-sterile and are intended to be sterilized by the end user. Sterilizations were conducted according to ANSI/AAMI/ISO 11137-1 (Sterilization Of Health Care Products - Radiation - Part 1: Requirements For Development, Validation, And Routine Control Of A Sterilization Process For Medical Devices) and ANSI/AAMI/ISO 11137-2 (Sterilization Of Health Care Products - Radiation -Part 2: Establishing The Sterilization Dose), for the irradiation process, as well as, ANSI/AAMI/ISO 17665-1 (Sterilization of health care products - Moist heat - Part 1 Requirements for the development, validation and routine control of a sterilization process for medical devices) and ANSI/AAMI/ISO 17665-2 (Sterilization Of Health Care Products - Moist Heat - Part 2: Guidance On The Application Of ANSI/AAMI/ISO 17665-1) for the steam sterilization process. The results of the sterilization validations support a minimum sterility assurance level (SAL) of 10-°.

8. Clinical Performance Data

No human clinical data were included to support substantial equivalence.

9. Conclusion Regarding Substantial Equivalence

The proposed MIS Lance+ Internal Hex Dental implants and the proposed MIS Internal Hex Cobalt Chrome abutments have the same intended use, incorporate the same fundamental technology, and have similar indications for use as the predicate and reference devices. The results of the testing included in this premarket notification support a determination of substantialequivalence.

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.