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 & UNO) 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.

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.

Device Description

a. MIS LOCKiT Abutments System
MIS LOCKiT abutments system contains titanium abutments coated with titanium nitride (TiN). MIS LOCKIT abutments system is intended to be used in completely edentulous jaws and connects to an overdenture to allow its insertion and removal.

MIS LOCKiT abutments connect directly to the implant by their threading. MIS LOCKiT abutments are available in three different platforms (narrow platform (NP), standard platform (SP) and wide platform (WP)) and two connection types (conical connection and internal hex connection). LOCKiT abutments system contains straight abutments only.

MIS LOCKiT abutments are provided in the following gingival heights:

. Narrow platform: 1, 2, 3, 4, 5 mm
. Standard platform: 1, 2, 3, 4, 5 mm
Wide platform: . 1, 3, 5 mm

MIS LOCKIT internal hex connection abutments are compatible with MIS internal hex implants cleared under K040807 and K180282 (M4, LANCE and SEVEN Systems).

MIS LOCKiT conical connection abutments are compatible with MIS implants cleared under K112162, K163349 and K172505 (C1 and V3 Systems).

b. OT-Equators and Ball Attachments
Ball Attachments and OT-Equators are used to connect to an overdenture bar to allow its insertion and removal. They are connected directly to the implant by their distal threading, and are mostly used in complete edentulous jaws. The main difference between them is that ball attachments have a higher profile and ball shaped head, while the OT-equators have a lower profile and a truncated head. Both are made from Titanium 6Al-4V ELI and feature a Titanium Nitride (TiN) coating for increased resistance to wear.

Internal hex OT-Equators and Ball Attachments are available in three different platforms (narrow platform (NP), standard platform (SP) and wide platform (WP) and are available in the following gingival heights:

. Narrow platform: 1, 2, 3, 4, 5 mm
. Standard platform: 1, 2, 3, 4, 5 mm
Wide platform: 1, 3, 5 mm .

MIS Internal hex OT-Equators and Ball Attachments are compatible with MIS internal hex implants cleared under K040807 and K180282 (M4, LANCE and SEVEN Systems).

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA for dental implant abutments. It details the device, its intended use, and how it is substantially equivalent to legally marketed predicate devices. The document explicitly states that no clinical performance data was required or conducted for this device submission. Instead, the substantial equivalence was demonstrated through non-clinical performance data, primarily mechanical testing (fatigue testing), and comparisons to predicate devices.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of clinical performance (human-in-the-loop, MRMC, expert ground truth, training/test sets for AI models, etc.) is not applicable to this document. The device in question is a physical dental abutment, not an AI/software device that would typically undergo the kind of clinical validation described in the prompt.

However, I can extract the acceptance criteria and performance data for the mechanical testing which was used to demonstrate substantial equivalence:

Acceptance Criteria and Reported Device Performance (Non-Clinical / Mechanical Testing)

Acceptance Criteria (Equivalent to Predicate)	Reported Device Performance
Withstand 5,000,000 cycles without failure at a substantially equivalent load to cited predicates (for MIS Internal Hex LOCKiT abutments).	The test articles were able to withstand 5,000,000 cycles without failure at a substantially equivalent load to the cited predicates.
Equivalent mechanical properties to MIS Conical Connection CONNECT abutments (K173326) and Zest Locator® Implants Attachments (K072878) in terms of fatigue limit for MIS LOCKiT abutments.	Fatigue testing was conducted on MIS conical connection CONNECT abutments, which represent a worst-case in terms of mechanical properties due to geometric design, supporting the performance of MIS Conical Connection LOCKiT abutments. The endurance limit for the LOCKiT assembly was compared with the corresponding worst case for CONNECT and Zest Locator® systems. (Implicitly, the LOCKiT met or exceeded these limits if "substantially equivalent" was claimed).
Equivalent mechanical strength to narrower emergence profile devices for MIS internal hex OT-Equators and Ball Attachments.	Mechanical performance of MIS internal hex OT-Equators and Ball Attachments is supported by fatigue testing conducted on MIS Internal Hex LOCKIT abutments, which are a worst case in terms of mechanical strength as they have a narrower emergence profile than the OT-Equators and Ball Attachments.
Sterilization validated according to ANSI/AAMI/ISO 17665-1:2006 and ANSI/AAMI/ISO 17665-2:2009 for gravity displacement and pre-vacuum steam sterilization.	Steam sterilization parameters were validated according to ANSI/AAMI/ISO 17665-1:2006 and ANSI/AAMI/ISO 17665-2:2009 for two methods: gravity displacement steam sterilization and pre-vacuum steam sterilization.
Disinfection procedure validated with a reduction of at least 10^6 of the microbiological challenge according to ANSI/AAMI/ISO 11737-1:2006 (R) 2011, AAMI TIR 30:2011 and AAMI TIR 12:2010.	The disinfection procedure was validated in accordance with ANSI/AAMI/ISO 11737-1:2006 (R) 2011, AAMI TIR 30:2011 and AAMI TIR 12:2010 by demonstrating a reduction of at least 10^6 of the microbiological challenge.

Regarding the other points of the prompt, as applied to this document:

Sample size used for the test set and the data provenance: For mechanical testing, the "test set" would be the physical samples of the abutments and implants. The document mentions "worst case implants and abutments" being chosen for testing, such as "narrowest implants loaded with the abutments which have the maximum gingival height." The exact number of samples tested for each configuration is not explicitly stated in this summary, but would be detailed in the full test reports. The provenance is the manufacturer, MIS Implants Technologies Ltd., located in Israel. The studies are prospective in the sense that they were conducted for the purpose of this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by physical measurement and engineering standards (e.g., ISO 14801:2016 for fatigue testing), not expert consensus.
Adjudication method: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a physical device, not an AI/software for diagnostic imaging interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device.
The type of ground truth used: For mechanical testing, the ground truth is defined by the performance standards (e.g., ISO 14801:2016) and direct physical measurement of fatigue, tensile strength, etc.
The sample size for the training set: Not applicable. This is a physical device, not an AI model requiring a training set.
How the ground truth for the training set was established: Not applicable.

In summary, this FDA 510(k) submission focuses on demonstrating substantial equivalence through non-clinical (mechanical and biocompatibility) testing, as is typical for Class II physical medical devices like dental abutments. It does not involve AI/software validation or human-reader studies.

Summary

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

January 28, 2019

MIS Implants Technologies Ltd. Arbel Shezaf RA Coordinator P.O. Box 7 Bar Lev Industrial Park, 2015600 ISRAEL

Re: K18228

Trade/Device Name: MIS LOCKiT Abutments System, OT-Equators and Ball Attachments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: January 3, 2019 Received: January 3, 2019

Dear Arbel Shezaf:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Andrew I. Steen -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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Indications for Use

510(k) Number (if known)

K182228

Device Name

MIS LOCKiT Abutments System, OT-Equators and Ball Attachments

Indications for Use (Describe)

Narrow implants (03.3mm & UNO) 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.

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.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/1 description: The image shows the logo for MIS Implants Technologies Ltd. The logo consists of the letters "MIS" in blue, with the "M" and "I" connected and the "S" stylized as a curved line. To the right of the letters, the words "Implants Technologies Ltd." are written in a smaller font size.

510(k) Summary

1. Submitter

MIS Implants Technologies Ltd. P.O. Box 7, Bar Lev Industrial Park 2015600 ISRAEL

Telephone: +972-4-9016802 Fax: +972-4-9918623

Contact: Arbel Shezaf Date Prepared: January 22, 2019

2. US Agent: Motti Weisman - VP Marketing

MIS Implants Technologies Inc. 18-00 Fair Lawn Ave Fair Lawn NJ 07410 Phone: (201) 797-9144 Fax: (201) 797-9145

3. Device Identification

Trade/Proprietary Name:	MIS LOCKIT Abutments System, OT-Equators and Ball Attachments
Common/Usual Name:	Dental implant abutment
Classification Name:	Endosseous dental implant abutment
Regulation Number:	872.3630
Product Code:	NHA
Device Class:	Class II
Classification Panel:	Dental Devices Panel

4. Predicate Device(s)

Primary predicate device:

. MIS Conical Connection Equators cleared under K163349
Reference devices:
. Zest Locator® Implants Attachments cleared under K072878
MIS Conical Connection Equators cleared under K172505
MIS Internal Hex Connection Equators cleared under K180282 ●
MIS CONNECT Conical Connection Abutment cleared under K173326 ●

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Image /page/4/Picture/0 description: The image shows the logo for MIS Implants Technologies Ltd. The logo features the letters "MIS" in a stylized, connected font, with the "I" appearing as a vertical line. To the right of the logo is the text "Implants Technologies Ltd." in a smaller, sans-serif font.

MIS Conical Connection Implants cleared under K112162 .
MIS Dental Implant System cleared under K040807 ●

5. Device Description

a. MIS LOCKiT Abutments System

MIS LOCKiT abutments system contains titanium abutments coated with titanium nitride (TiN). MIS LOCKIT abutments system is intended to be used in completely edentulous jaws and connects to an overdenture to allow its insertion and removal.

MIS LOCKiT abutments are provided in the following gingival heights:

. Narrow platform: 1, 2, 3, 4, 5 mm
. Standard platform: 1, 2, 3, 4, 5 mm
Wide platform: . 1, 3, 5 mm

MIS LOCKIT internal hex connection abutments are compatible with MIS internal hex implants cleared under K040807 and K180282 (M4, LANCE and SEVEN Systems).

MIS LOCKiT conical connection abutments are compatible with MIS implants cleared under K112162, K163349 and K172505 (C1 and V3 Systems).

b. OT-Equators and Ball Attachments

Ball Attachments and OT-Equators are used to connect to an overdenture bar to allow its insertion and removal. They are connected directly to the implant by their distal threading, and are mostly used in complete edentulous jaws. The main difference between them is that ball attachments have a higher profile and ball shaped head, while the OT-equators have a lower profile and a truncated head. Both are made from Titanium 6Al-4V ELI and feature a Titanium Nitride (TiN) coating for increased resistance to wear.

. Narrow platform: 1, 2, 3, 4, 5 mm
. Standard platform: 1, 2, 3, 4, 5 mm
Wide platform: 1, 3, 5 mm .

MIS Internal hex OT-Equators and Ball Attachments are compatible with MIS internal hex implants cleared under K040807 and K180282 (M4, LANCE and SEVEN Systems).

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s Technologies Ltd.

6. Indications for Use

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.

7. Substantial Equivalence Discussion

a. MIS LOCKiT Abutments System:

The predicate device for the Conical Connection MIS LOCKiT abutments is MIS Conical Connection Equators cleared under K163349 and K172505, while the predicate device for the Internal Hex Connection MIS LOCKiT abutments is the MIS Internal Hex Connection Equators recently cleared under K180282. Two reference devices for MIS LOCKIT abutments are also included, specifically, the Zest Locator® Implants Attachments (K072878) and MIS CONNECT Concal Connection Abutment (K173326). All devices have identical intended use. The indications listed for the LOCKiT are identical to the indications for MIS Equators and do not meaningfully differ from the Zest Locator.

All abutments are made from titanium or its alloy, and undergo TiN coating. In regards to the distal geometry, the conical implant connection geometry for the Conical Connection MIS LOCKIT is identical to the MIS Conical Connection Equators while the internal hex connection is equivalent to MIS Internal Hex Connection Equators. The subject and the predicate devices are available in the same gingival heights - 1, 2, 3, 4, 5 mm (both conical and internal hex connection, narrow and standard platform) and 1, 3, 5 mm (both conical and internal hex connections, wide platform).

MIS CONNECT Conical Connection Abutments and Zest Locator® Implants Attachments were chosen as a reference device in terms of fatigue limit. MIS LOCKIT abutment (internal hexagon connection, NP and SP) were tested in order to determine the fatigue limit value of an implant-abutment assembly. The endurance limit for the LOCKiT assembly was compared with the corresponding worst case for CONNECT and Zest Locator® systems.

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Image /page/6/Picture/0 description: The image shows the word "mis" in blue. The letters are connected and stylized, with the "m" having a wavy appearance, the "i" having a dot above it, and the "s" having a curved shape. The text is simple and clean, with a focus on readability.

Implants Technologies Ltd.

Trade Name	MIS LOCKITAbutments (conicaland internal hexconnection)New device	MIS Equators(conical and internalhex connection)Primary predicate	MIS CONNECTConical ConnectionAbutmentsReference device(fatigue strength)	ZEST Locator ®Implants AttachmentsReference device(proximal connection)
510(k) Number	Subject	ConicalConnection:K163349, K172505Internal HexConnection:K180282	K173326	K072878
Manufacturer	MIS ImplantsTechnologies Ltd.	MIS ImplantsTechnologies Ltd.	MIS ImplantsTechnologies Ltd.	Zest Anchors LLC.
Device Class	Class II	Class II	Class II	Class II
Product Code(s)	NHA	NHA	NHA	NHA
Regulation	Endosseous dental	Endosseous dental	Endosseous dental	Endosseous dental
Description	implant abutment	implant abutment	implant abutment	implant abutment
Regulation	872.3630	872.3630	872.3630	872.3630
Number
Intended use:	Dental implantabutments areintended to be usedin the upper or lowerjaw and used forsupporting toothreplacements torestore chewingfunction. Theabutments incombination withendosseous implantsare used as thefoundation foranchoring toothreplacements ineither jaw. Intendedfor fully edentulousjaw retaining a tissuesupportedoverdenture.	Dental implantabutments areintended to be usedin the upper or lowerjaw and used forsupporting toothreplacements torestore chewingfunction. Theabutments incombination withendosseous implantsare used as thefoundation foranchoring toothreplacements ineither jaw. Intendedfor fully edentulousjaw retaining a tissuesupportedoverdenture.	Dental implantabutments areintended to be usedin the upper or lowerjaw and used forsupporting toothreplacements torestore chewingfunction. Theabutments incombination withendosseous implantsare used as thefoundation foranchoring toothreplacements ineither jaw. Intendedfor fully edentulousjaw retaining a tissuesupportedoverdenture.	Dental implantabutments are intendedto be used in the upperor lower jaw and usedfor supporting toothreplacements to restorechewing function. Theabutments incombination withendosseous implants areused as the foundationfor anchoring toothreplacements in eitherjaw. Intended for fullyedentulous jawretaining a tissuesupported overdenture.
Indications foruse:	MIS dental implantsystems are intendedto be surgicallyplaced in the bone ofthe upper or lowerjaw arches to providesupport for prostheticdevices, such asartificial teeth, inorder to restoremasticatory function.When a one-stagesurgical procedure is	MIS dental implantsystems are intendedto be surgicallyplaced in the bone ofthe upper or lowerjaw arches to providesupport for prostheticdevices, such asartificial teeth, inorder to restoremasticatory function.	MIS Dental ImplantSystems are intendedto be surgicallyplaced in the bone ofthe upper or lowerjaw arches to providesupport for prostheticdevices, such asartificial teeth, inorder to restoremasticatory function.	The Locator® ImplantAttachment System isdesigned for use withoverdentures or partialdentures, retained inwhole or in part, byendosseous implants inthe mandible ormaxilla.
Trade Name	MIS LOCKITAbutments (conicaland internal hexconnection)New device	MIS Equators(conical and internalhex connection)Primary predicate	MIS CONNECTConical ConnectionAbutmentsReference device(fatigue strength)	ZEST Locator ®Implants AttachmentsReference device(proximal connection)
	applied, the implantmay be immediatelyloaded when goodprimary stability isachieved and theocclusal load isappropriate.Narrow implants(Ø3.3mm & UNO)are indicated for usein surgical andrestorativeapplications forplacement only in themandibular central,lateral incisor andmaxillary lateralincisor regions ofpartially edentulousjaws, to providesupport for prostheticdevices such asartificial teeth.Mandibular centraland lateral incisorsmust be splinted ifusing two or morenarrow implantsadjacent to oneanother.The long MIS (18 &20 mm) implants canbe used in a tiltedmanner.MIS short implantsare to be used onlywith straightabutments.M4 short implantsare indicated fordelayed loading only.	When a one-stagesurgical procedure isapplied, the implantmay be immediatelyloaded when goodprimary stability isachieved and theocclusal load isappropriate.Narrow implants("3.3mm & UNO)are indicated for usein surgical andrestorativeapplications forplacement only in themandibular central,lateral incisor andmaxillary lateralincisor regions ofpartially edentulousjaws, to providesupport for prostheticdevices such asartificial teeth.Mandibular centraland lateral incisorsmust be splinted ifusing two or morenarrow implantsadjacent to oneanother.For the internal hexconnection MISEquators, there is afollowing addition tothe indications foruse:The long MIS (18 &20 mm) implants canbe used in a tiltedmanner.MIS short implantsare to be used onlywith straightabutments.M4 short implantsare indicated for	When a one-stagesurgical procedure isapplied, the implantmay be immediatelyloaded when goodprimary stability isachieved and theocclusal load isappropriate.Narrow implants(Ø3.3mm) areindicated for use insurgical andrestorativeapplications forplacement only in themandibular central,lateral incisor andmaxillary lateralincisor regions ofpartially edentulousjaws, to providesupport for prostheticdevices such asartificial teeth, inorder to restore thepatient chewingfunction. Mandibularcentral and lateralincisors must besplinted if using twoor more narrowimplants adjacent toone another.
Trade Name	MIS LOCKITAbutments (conicaland internal hexconnection)New device	MIS Equators(conical and internalhex connection)Primary predicate	MIS CONNECTConical ConnectionAbutmentsReference device(fatigue strength)	ZEST Locator ®Implants AttachmentsReference device(proximal connection)
		delayed loading only.
Material(s)	Ti 6A1 4V ELI	Ti 6A1 4V ELI	Ti 6A1 4V ELI	Ti 6A1 4V ELI
SurfaceTreatment	TiN coating, SP andWP also coloranodized	TiN coating, SP andWP also coloranodized	Anodized	TiN coating
Connection of theAbutment to theImplant	• ConicalConnectionwithout indexes• Internal HexConnection	• ConicalConnectionwithout indexes• Internal HexConnection	• ConicalConnectionwithout indexes	• ConicalConnectionwithout indexes• Internal HexConnection
Gingival height	NP / SP (bothconnections): 1, 2, 3,4, 5 mmWP (bothconnections): 1, 3, 5mm	NP / SP: 1, 2, 3, 4, 5mmWP: 1, 3, 5 mm	NP: 2, 3 mmSP: 1.5, 2, 3, 4 mmWP: 1.5, 2, 3, 4 mm	NP / SP (conicalconnection ): 1, 2, 3, 4,5 mmNP / SP / WP (internalhex connection ): 0, 1,2, 3, 4, 5, 6 mm
Platform	NP / SP / WP (bothconnections)	NP / SP / WP	NP / SP / WP	Conical Connection:NP / SPInternal HexConnection: NP / SP /WP
AbutmentAngulation	0°	0°	0°	0°
MaximumImplantAngulationAllowed	20 degrees ofdivergence (40degrees betweenimplants)	ConicalConnection:15 degrees ofdivergence (30degrees betweenimplants)Internal HexConnection:No angulation isallowed	20 degrees ofdivergence (30degrees betweenimplants)	20 degrees ofdivergence (40 degreesbetween implants)
SterilizationMethod	Product providednon-sterile	Product providednon-sterile	Product providednon-sterile	Product provided non-sterile

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Image /page/7/Picture/0 description: The image shows the word "mis" in blue. The letters are stylized and connected. The "m" is a curvy line, the "i" has a dot above it, and the "s" is a rounded shape with a flat bottom.

Implants Technologies Ltd.

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Image /page/8/Picture/0 description: The image shows a logo that spells out the letters 'mis' in a stylized, blue font. The 'm' is represented by two connected, angled lines, while the 'i' is a simple vertical line with a dot above it. The 's' is a curved line that resembles a backwards 'c' shape. The logo has a clean and modern design.

mplants Technologies Ltd.

b. OT-Equators and Ball Attachments

OT-Equators and Ball Attachments were cleared under K180282. No changes have been made since the clearance, as shown in the following table.

They were cleared with the following instructions:

"OT-Equators and straight Ball Attachments are not to be used with implants placed at an angle."

Due to fatigue tests provided in this submission, the instruction is changed to:

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Image /page/9/Picture/0 description: The image shows the logo for MIS Implants Technologies Ltd. The logo features the letters "MIS" in a stylized blue font, with a vertical line separating the letters from the company name. The company name, "Implants Technologies Ltd.," is written in a smaller, lighter font to the right of the vertical line.

"OT-Equators and straight Ball Attachments allow a maximum 30 divergence between two implant constructs, with each implant/abutment construct having no more than 15°correction."

Trade Name	MIS internal hex OT-Equators and Ball Attachments	MIS internal hex OT-Equators and Ball Attachments
510(k) Number	Subject	K180282
Manufacturer	MIS Implants Technologies Ltd.	MIS Implants Technologies Ltd
Device Class	Class II	Class II
Product Code(s)	NHA	NHA
Regulation Description	Endosseous dental implant abutment	Endosseous dental implant abutment
Regulation Number	872.3630	872.3630
Intended use:	Dental implant abutments are intended tobe used in the upper or lower jaw and usedfor supporting tooth replacements to restorechewing function. The abutments incombination with endosseous implants areused as the foundation for anchoring toothreplacements in either jaw. For fullyedentulous jaw retaining a tissue-supportedoverdenture.	Dental implant abutments are intended to beused in the upper or lower jaw and used forsupporting tooth replacements to restorechewing function. The abutments incombination with endosseous implants areused as the foundation for anchoring toothreplacements in either jaw. For fullyedentulous jaw retaining a tissue-supportedoverdenture.
Indications for use:	MIS dental implant systems are intended tobe 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 (Ø3.3mm & 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 long MIS (18 & 20 mm) implants canbe used in a tilted manner.MIS short implants are to be used only withstraight abutments.M4 short implants are indicated for delayedloading only	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 (Ø3.3mm & 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 long MIS (18 & 20 mm) implants can beused in a tilted manner.MIS short implants are to be used only withstraight abutments.M4 short implants are indicated for delayedloading only
Instruction for use	OT-Equators and straight Ball Attachmentsallow a maximum 30° divergence betweentwo implant constructs, with each implant/abutment construct having no more than15° correction	OT-Equators and straight Ball Attachmentsare not to be used with implants placed at anangle.
Material(s)	Ti 6A1 4V ELI per ASTM F136	Ti 6A1 4V ELI per ASTM F136
Surface Treatment	TiN coating after machined	TiN coating after machined
Trade Name	MIS internal hex OT-Equators and BallAttachments	MIS internal hex OT-Equators and BallAttachments
Connection Type	Internal hexagon	Internal hexagon
Platform	NP, SP, WP	NP, SP, WP
Abutment angulation	0°	0°
Maximum ImplantAngulation Allowed	15 degrees of divergence (30 degreesbetween implants)	0 degrees of divergence
Abutment Diameters	NP: ball 4.0, equator 4.1 mmSP: ball & equator 4.1 mmWP: ball & equator 5.0 mm	NP: ball 4.0, equator 4.1 mmSP: ball & equator 4.1 mmWP: ball & equator 5.0 mm
Gingival height	1, 2, 3, 4, 5 mm	1, 2, 3, 4, 5 mm
Sterilization Method	Product provided non sterile	Product provided non sterile

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Image /page/10/Picture/0 description: The image shows the logo for MIS Implants Technologies Ltd. The logo consists of the letters "MIS" in blue, with the "M" and "I" connected and the "S" slightly offset to the right. To the right of the letters is the text "Implants Technologies Ltd." in a smaller font size.

8. Non-Clinical Performance Data

As part of demonstrating the substantial equivalence of the MIS LOCKiT Abutments System, OT-Equators and Ball Attachments to the predicate devices listed in this 510(k) submission, MIS Implants Technologies completed a number of non-clinical performance tests:

Biocompatibility The subject device is manufactured using identical manufacturing methods, in the . same manufacturing facility, and using the same raw material as the previously cleared predicate, K040807. The subject device is packaged using identical materials and processing as the predicate. Finally the subject device has the same intended use, patient contact duration and type as the predicate. For these reasons, biocompatibility testing was not required to support the substantial equivalence of the subject device.
. Mechanical testing
- o Fatigue testing of MIS Internal Hex LOCKiT abutments was conducted in accordance with ISO 14801:2016. The worst case implants and abutments chosen for the tests were the narrowest implants loaded with the abutments which have the maximum gingival height for both narrow and standard platforms. The test articles were able to withstand 5,000,000 cycles without failure at a substantially equivalent load to the cited predicates. The fatigue test conducted on the standard platform worst case implant-abutment assembly supports the wide platform implants as the SP is a worst case in terms of diameter and wall thickness, and both SP and WP implants are made of the same material.
- Mechanical performance of MIS Conical Connection LOCKiT abutments is supported by о fatigue testing that was conducted on MIS conical connection CONNECT abutments (cleared

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Image /page/11/Picture/0 description: The image shows the logo for MIS Implants Technologies Ltd. The logo consists of the letters "MIS" in a stylized font, with a curved line above the "M" and a horizontal line extending from the "S". To the right of the letters, the words "Implants Technologies Ltd." are written in a smaller, simpler font. The logo is in blue and white.

under K173326) which represent a worst-case in terms of mechanical properties due to geometric design.

Mechanical performance of MIS internal hex OT-Equators and Ball Attachments is supported o by the fatigue testing that was conducted on MIS Internal Hex LOCKIT abutments, which are a worst case in terms of mechanical strength as they have a narrower emergence profile than the OT-Equators and Ball Attachments.
Sterilization testing (steam sterilization by the user): The steam sterilization parameters were . validated according to ANSI/AAMI/ISO 17665-1:2006 and ANSI/AAMI/ISO 17665-2:2009 for two methods: gravity displacement steam sterilization and pre vacuum steam sterilization.
Disinfection validation: the disinfection procedure was validated in accordance with ANSI/AAMI/ISO . 11737-1:2006 (R) 2011, AAMI TIR 30:2011 and AAMI TIR 12:2010 by demonstrating a reduction of at least 106 of the microbiological challenge.

9. Clinical Performance Data

There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

10. Summary

The comparison between the subject device and the predicate devices has shown that the indications for use, principles of operation, technological characteristics and materials were similar, and that the differences did not raise new safety and effectiveness issues. Furthermore, performance testing showed that the predicate device is at least equivalent to the predicates by means of performance.

11. Conclusions

MIS LOCKiT Abutments System, OT-Equators and Ball Attachments have the same intended use, incorporate the same fundamental technology, and have similar indications for use as the predicate. Test data to verify the performance of the MIS LOCKIT Abutments System, OT-Equators and Ball Attachments has been provided including dynamic fatigue, pull-out tests and sterilization. The results of this testing. combined with the design and intended use comparison with the predicate device, support substantial equivalence.

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)