DenTack QUAD Dental Implants and Prostheses are intended for surgical placement in the maxilla and/or in the mandible to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous jaws utilizing delayed loading or immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Device Description

DenTack has developed a range of expandable dental implants made of Titanium to serve the need of patients that require partial or complete tooth restoration. The implant is placed so its apical end is in the trabecular (spongy) bone like any other implant. Once in place, the apical portion of the implant is expanded to achieve increased contact surface area with the surrounding bone. The system also includes various accessories that attach to the implant. All DenTack's implant bodies are made of a combination of Titanium alloy according to ASTM F136 and c.p. titanium according to ASTM F67. Abutments are made of same Titanium alloy while denture components are made of stainless-steel and polymers.

DenTack's QUAD Implants are available in outer diameter (OD) of: 3.75 and 4.1 mm. The implants' length dimensions are from 7 to 11 mm.

DenTack's Prostheses are identified as follows:
Metal housing
Plastic cup
Straight Multi-unit Sleeve
Straight Multi-unit Screw
Angled abutments 15° and 25°
Angled abutments 15° Large
Ball Attachments (1, 2 & 3 mm)
Direct screw platform
Straight abutments
Screw retained abutments
Straight Multi-unit abutments
Healing caps
Cover Screw

The QUAD expansion is performed using a reusable Expansion Tool and Ratchet Torque.

AI/ML Overview

Here's an analysis of the acceptance criteria and supporting studies for the DenTack QUAD Dental Implants and Prostheses based on the provided document:

Acceptance Criteria and Device Performance for DenTack QUAD Dental Implants and Prostheses

1. Table of Acceptance Criteria and Reported Device Performance

Test/Characteristic	Acceptance Criteria	Reported Device Performance
Mechanical Performance
Fatigue Test (ISO 14801:2007)	Device performs at least as good as or better than the predicate device.	"The QUAD met the acceptance criteria and performed at least as good as or better than the predicate device." Tested on worst-case configuration (25° abutment with narrowest implant OD).
Evaluation of Minimal Rotation Torque after Placement and Expansion	Test results to be similar to and thus equivalent to the predicate device.	"The tests results found to be very similar and thus equivalent. The QUAD met the acceptance criteria and performed at least as good as or better than the predicate device."
Partially expanded QUAD Implant Reciprocating Effect Test	No additional damage to surrounding bone or implant from counterclockwise/clockwise rotation; performs similarly to reference device.	"The study demonstrated that both the surrounding bone and the implant were not negatively affected by counterclockwise/clockwise rotation and that the QUAD performed similarly to the reference device."
Material & Surface Characteristics
Surface Analysis (SEM)	-	Implant surface tested using SEM. (No specific acceptance criteria or performance metric beyond "tested" is stated).
Biocompatibility (ISO 10993-1, -5, -12)	No incompatibility potential or adverse biological effect.	"The chemical and biological tests have not revealed any incompatibility potential or any adverse effect."
Sterilization & Packaging
Gamma Sterilization Validation (ISO 11137-2, AAMI TIR 33 / ISO TS 13004)	Successful sterilization according to standards.	"Sterilization was conducted with successful results, using Gamma Irradiation according to VDmax method..."
Steam Sterilization Validation (ISO 17665-1:2006, ANSI AAMI ST79:2010, ANSI AAMI ST77:2013)	Validation results support SAL 10⁻⁶; IFU in-line with validation.	"The validation results supported SAL 10-6. IFU (instructions for use) are in-line with the validation results."
Shelf Life Validation (ISO 11607-1)	Sterility maintained for the device shelf life.	"This validation confirmed that the sterility of DenTack's sterile products will be remained for the device shelf life."
Functional/Clinical Equivalence
QUAD Removal after Expansion	The expandable design does not cause additional damage to the surrounding tissue.	"The evaluation post implant removal showed that both implants performed equally in terms of interaction with the bone."

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical sample sizes for most of the individual tests. It generally refers to testing being conducted "for Dentistry - Implants - Dynamic fatigue test for endosseous dental implants" and "in comparison to predicate device" or "legally marketed device."

Fatigue Test (ISO 14801:2007): "Worst case configuration was selected." (Implies a specific combination of implant and abutment was tested, but no number of samples is given).
QUAD Removal after Expansion: "artificial bone was used and a reference legally marketed device for comparison." (No number of samples or explicit provenance beyond "artificial bone").
Evaluation of Minimal Rotation Torque: "artificial bone." (No number of samples).
Partially expanded QUAD Implant Reciprocating Effect Test: "a legally marketed device with similar instructions for use." (No number of samples).
Biocompatibility (ISO 10993-1, -5, -12): "final and sterilized products." (No number of samples).
Sterilization and Shelf Life Validations: Not specified, but generally follow specific standards.

The data provenance is largely implied to be laboratory-based testing using in vitro models (e.g., artificial bone) and comparisons to existing devices, rather than in vivo or human data. There is no information regarding country of origin for the data other than the company being based in Israel. The studies are by nature prospective as they are specifically conducted to support the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

No direct mention of experts or their qualifications establishing "ground truth" for the test set is provided. The studies described are primarily engineering and laboratory performance tests against industry standards (e.g., ISO, AAMI) or in comparison to predicate devices, rather than clinical studies requiring expert consensus on outcomes.

4. Adjudication Method for the Test Set

Not applicable. The tests are primarily physical, chemical, and mechanical evaluations against defined standards and comparative performance with predicate devices, not subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study was done. The document describes laboratory and engineering tests, not clinical studies involving human readers or cases.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

Not applicable. This is a physical medical device (dental implants and prostheses), not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the various studies is typically defined by:

Industry Standards: Compliance with international standards (e.g., ISO 14801, ISO 10993 series, ISO 11137-2, ISO 17665-1, ISO 11607-1).
Comparative Performance: The performance of legally marketed predicate devices or reference devices, establishing a benchmark for substantial equivalence.
Defined Benchmarks/Thresholds: For tests like sterilization success (SAL 10⁻⁶) or fatigue limits implied by ISO standards.
Qualitative Assessment: Such as "no additional damage" or "no incompatibility potential" demonstrated in material science or biological tests.

8. The Sample Size for the Training Set

Not applicable. There is no training set mentioned, as this is for a physical medical device clearance, not an AI/ML algorithm that requires training data.

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

Not applicable, as there is no training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

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

January 28, 2016

DenTack Implants Ltd c/o Ms. Tali Hazan Regulatory Consultant Talmed Ltd M.P. Upper Galilee Ramot Naftali, 13830 ISRAEL

Re: K152188

Trade/Device Name: QUAD Dental Implants and Prostheses Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: December 14, 2015 Received: December 17, 2015

Dear Ms. Hazan:

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.

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang -S

for 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K152188

Device Name

QUAD Dental Implants and Prostheses

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR
-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image is a logo for Dentack Implants. The logo features a series of blue arcs that get progressively larger, with a green circle behind the largest arc. To the right of the arcs is the word "DENTACK" in blue, with the word "IMPLANTS" in smaller letters below it. The "TACK" portion of "DENTACK" is on a green background.

510(K) SUMMARY FOR DENTACK'S QUAD DENTAL IMPLANTS AND PROSTHESES

DATE PREPARED: January 20, 2016

1. 510(K) OWNER NAME

DenTack Implants Ltd 24 HaTa'as St. POB 2405 Kfar-Saba 4464102 Israel Phone: +972-9-7660379, Fax: +972-9-7738280, Email: info@dentack.com.

Contact person name:

Ms. Tali Hazan - RA Consultant Phone: +972-(0)50-5292-304 Fax: +972-(0)722448981 Email: tali.hazan@talmed.co.il

2. DEVICE NAME AND CLASSIFICATION

Common/Usual Name: Dental Implants and Prostheses Proprietary/Trade name: QUAD Dental Implants and Prostheses Classification: DenTack's QUAD device has been classified as Class II device under the following classification names:

Classification Name	Product Code	21 CFR Ref.	Panel
Endosseous dental implant	Primary: DZESecondary: NHA	21 CFR 872.3640	Dental

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Image /page/4/Picture/0 description: The image shows the logo for Dentack Implants. The logo features a series of blue arcs emanating from a green circle, followed by the word "DENTACK" in blue, with a green rectangle behind it. Below "DENTACK" is the word "IMPLANTS" in a smaller font.

3. PREDICATE DEVICES

DenTack's QUAD Dental Implants and Prostheses are substantially equivalent to the following Predicate Devices (primary and secondary):

3.1 Primary Predicate Device: Sargon's Immediate Load Implant Model D: cleared under 510(k) number K981141 on June 23, 1999.
3.2 Reference Predicate Device: Biomet's Biomet 3i Dental Abutments and Restorative Components; cleared under 510(k) K072642 on December 20, 2002.
3.3 Reference Predicate Device: Nobel Biocare, NobelActive Internal Connection Implant; cleared under 510(k) K071370 on August 3, 2007.
3.4 Reference Predicate Device: Implant Direct, Legacy3 6mm Length Implants; cleared under 510(k) K131097 on August 22, 2013.

4. DEVICE DESCRIPTION

DenTack's QUAD Implants are available in outer diameter (OD) of: 3.75 and 4.1 mm. The implants' length dimensions are from 7 to 11 mm.

………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

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Image /page/5/Picture/0 description: The image shows the logo for Dentack Implants. The logo features a series of blue concentric circles emanating from a green sphere. To the right of the circles, the word "DENTACK" is written in a large, bold, blue font. Below "DENTACK", the word "IMPLANTS" is written in a smaller, thinner font.

DenTack's Prostheses are identified as follows:

Metal housing
Plastic cup
Straight Multi-unit Sleeve
Straight Multi-unit Screw
Angled abutments 15° and 25°
Angled abutments 15° Large
Ball Attachments(1, 2 & 3 mm)

Direct screw platform
Straight abutments
Screw retained abutments
Straight Multi-unit abutments
Healing caps
Cover Screw

The QUAD expansion is performed using a reusable Expansion Tool and Ratchet Torque.

5. INTENDED USE

DenTack OUAD Dental Implants and Prostheses are intended for surgical placement in the maxilla and/or in the mandible to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous jaws utilizing delayed loading, or immediate loading when good primary stability is achieved and with appropriate occlusal loading.

6. PERFORMANCE DATA

A series of performance tests and evaluations were performed to demonstrate that DenTack's Dental Implant System is substantially equivalence with the predicate devices. These tests are:

Fatigue Test This test was conducted according to ISO 14801:2007 standard a) for Dentistry -Implants - Dynamic fatigue test for endosseous dental implants and with accordance to FDA Guidance for Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments (dated: May 12, 2004). Worst case configuration was selected to reflect the most challenging situation for the implant and abutment.
………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

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Image /page/6/Picture/0 description: The image shows the logo for Dentack Implants. The logo features a series of blue arcs emanating from a green circle, followed by the word "DENTACK" in blue, with the word "IMPLANTS" in smaller letters underneath. The logo is clean and professional, suggesting a company that specializes in dental implants.

b) Surface analysis The implant surface was tested using the SEM (Scanning Electron Microscope).
QUAD Removal after Expansion This comparative test was conducted per C) DenTack protocol, in order to demonstrate that the expandable design does not cause additional damage to the surrounding tissue.

For the purpose of this test artificial bone was used and a reference legally marketed device for comparison. Both implants were "implanted" in the artificial bone and removed per instructions for use. The evaluation post implant removal showed that both implants performed equally in terms of interaction with the bone.

d) Evaluation of Minimal Rotation Torque after Placement and Expansion The test was conducted per DenTack protocol, in order to evaluate the minimal rotation torque after QUAD placement and expansion in the artificial bone.
This evaluation was conducted in comparison to predicate device, simulating the product use per their instructions for use. The tests results found to be very similar and thus equivalent. The QUAD met the acceptance criteria and performed at least as good as or better than the predicate device.

Partially expanded QUAD Implant Reciprocating Effect Test e)

The test was conducted per DenTack protocol, in order to demonstrate that the instructions to counterclockwise and clockwise rotation, when the QUAD only partially expanded, do not cause to an additional damage to the surrounding bone or to the implant. The test was conducted in comparison to a legally marketed device with similar instructions for use (counterclockwise rotation when insufficient insertion occurs). The study demonstrated that both the surrounding bone and the implant were not negatively affected by counterclockwise/clockwise rotation and that the QUAD performed similarly to the reference device.

Biocompatibility Biocompatibility was evaluated with accordance to ISO f) 10993-1 for Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, considering extractions and potential biological (cytotoxic) reaction.
The tests were conducted using final and sterilized products with accordance to above mentioned ISO 10993-1 as well as; ISO 10993-5 for Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity and;

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Image /page/7/Picture/0 description: The image shows the logo for Dentack Implants. The logo features a series of blue arcs emanating from a green sphere on the left side. To the right of the arcs is the word "DENTACK" in blue, with the "ACK" portion set against a green background. Below "DENTACK" is the word "IMPLANTS" in a smaller, sans-serif font.

ISO 10993-12 for Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials. The chemical and biological tests have not revealed any incompatibility potential or any adverse effect.

Gamma Sterilization Validation Sterilization was conducted with g) successful results, using Gamma Irradiation according to VDmax method with accordance to ISO 11137-2 for Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose, and in conjunction with AAMI TIR 33 (recently revised to: ISO TS 13004).
h) Steam Sterilization Validation Was performed to validate the instructions for steam sterilization provided by DenTack for prosthetic parts that are provided nonsterile and are to be steam sterilized by the user at the clinic. The validation was conducted with accordance to ISO 17665-1:2006, ANSI AAMI ST79:2010 and ANSI AAMI ST77:2013. The validation results supported SAL 10°. IFU (instructions for use) are in-line with the validation results.
Shelf life validation Was performed with accordance to ISO 11607-1 for i) Packaging for Terminally Sterilized Medical Devices – Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems. This validation confirmed that the sterility of DenTack's sterile products will be remained for the device shelf life.

All results are supporting DenTack's labeling claims in order to establish substantial equivalency with the selected predicate devices.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 7.

DenTack Implants are manufactured from biocompatible Titanium. Implant surface is treated by an established sand-blasting method.

Restorative components are manufactured with common titanium alloy, stainless-steel and polymers.

The proposed DenTack's Dental Implant System has similar indications for use, technological characteristics, mode of operation and, performance specification as the above identified predicate devices. The proposed device utilizes same intended use as the predicates and is placed using the same methodology as all of the selected predicate devices. Both the proposed and predicate devices function in the same manner providing support for prosthetic devices in the upper or lower jaw. Therefore it was concluded that they are substantially equivalent.

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Image /page/8/Picture/0 description: The image shows the logo for Dentack Implants. The logo features a series of overlapping blue circles on the left, with a green sphere in the center. To the right of the circles is the word "DENTACK" in blue, with the word "IMPLANTS" in smaller letters underneath. The word "DENTACK" is partially overlaid on a green rectangle.

Certain differences between subject and predicate devices did not alter the substantial equivalent determination, since they were established by performance testing. The implant expansion was evaluated through tests 'c'-'d' described above. Differences in abutment maximal angulation and connection types were evaluated through fatigue tests under worst case scenario (DenTack's 25° abutment with the narrowest implant OD). Differences between the submission device and the primary predicate with respect to surgical protocol for rotation after partial expansion are supported by the reference predicate K071370 and the comparative partial expansion rotation performance testing. Differences between the submission device and the primary predicate with respect to implant length are supported by the reference predicate K131097.

The comparison of the similarities and differences between QUAD implant and predicated devices are hereby presented in the tables below:

Feature	- Primary Predicate Device -Sargon's 510(k) K981141	- New Device -DenTack's QUAD
Intended Use	For use in either partially or fully edentulousmandibles and maxillae as a final orintermediary abutment for fixed detachableprosthesis and for use in support of freestanding restorations with or without theinvolvement of adjacent dentition.	DenTack Dental Implants andProstheses are intended for surgicalplacement in the maxilla and/or in themandible to provide a means forprosthetic attachment in single toothrestorations and in partially or fullyedentulous jaws utilizingconventional, delayed or immediateloading when good primary stabilityis achieved and with appropriateocclusal loading.
PatientPopulation	Edentulous or partially Edentulousindividuals	Edentulous or partially Edentulousindividuals
Material	Titanium alloy ELI	Titanium
Implant Model	Sargon Immediate Load Implant(expandable)	DenTack QUAD Dental Implants(expandable) for conventional, delayed orimmediate load.
ImplantDimensions	Length (mm): 10, 13,16Diameter (mm): 3.8	Length (mm): 7, 8, 9, 10, 11Diameter (mm): 3.75, 4.1
Surface	Alumina blasting (grit blasting and then acidetching surface)	Sand Blasting and acid etching

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Image /page/9/Picture/0 description: The image shows the logo for Dentack Implants. The logo features a series of concentric circles on the left, transitioning into a green sphere. To the right of the circles is the word "DENTACK" in a bold, dark blue font, with the word "IMPLANTS" in a smaller font underneath.

Feature	- Primary Predicate Device -Sargon's 510(k) K981141	- New Device -DenTack's QUAD
Implants Design	Apically expandable root form dental implant.	Apically expandable root form dental implant.
ExpansionMechanism	Screw driver manipulates internal parts untilexpanded.	Expansion tool is inserted in the implantupper platform and implant is expandedusing the ratchet torque.
Sterility	Sterile by Gamma Irradiation	Sterile by Gamma Irradiation
Placementmethod	Placing the implant immediately after drilling	Placing the implant immediately afterdrilling
Self-Tapping	Yes	Yes
Connection type	Internal and External hex	Internal hex
Abutmentconnection	With and without abutment	With abutment
Maximumabutment angle	N/A(Sargon 510(k) refers only to the implant)	25°

Subject	- Reference Predicate Device -	- New Device -
	Biomet 510(k) K072642	DenTack Prostheses
Indications forUse	BIOMET 3i Dental Abutments are intendedfor use as accessories to endosseous dentalimplant to support a prosthetic device in apartially or completely edentulous patient. Adental abutment is intended for use to supportsingle and multiple tooth prosthesis, in themandible or maxilla. The prosthesis can bescrew retained or cement retained.Restorative Components:• Temporary Healing Abutments areintended for use to shape and maintain thesoft tissue opening during healing.• Castable restorative components areintended for use as accessories toendosseous dental implants to aid in thefabrication of dental prosthetics.• Screw components are intended for use asaccessories to endosseous dental implantsfor retention of screw retained abutmentsto the dental implant.	Same indications and clinical purpose
Subject	- Reference Predicate Device -Biomet 510(k) K072642	- New Device -DenTack Prostheses
ItemsIdentificationand Description	IPAP462G, Angled abutment 8 mm length15° angle	Angled Abutment 8.5 mm length 15°angle
	IPAP474G Angled Abutment 11.5 mmlength 15° angle	Angled Abutment, large, 11.6 mmlength 15° angle
	IPAP462G Angled Abutment (AA) 8 mmlength 15° angle.Note that except for the angle, DenTack AA25° is the same in all respects to the AA-15°and that AA 25° was used as part of theworst case scenario in the fatigue test whereit showed good failure resistance.	Angled Abutment 8.5 mm length 25°angle
	Ball Attachment (BA) Similar to Biomet partpresented for DenTack's Ball Attachment(BA), dimensions vary according to gingivalheight.	Ball attachment abutment 3 mm height
		Ball attachment abutment 2 mm height
	OSO20O-Ring Abutment 2 mm height	Ball attachment abutment 1 mm height
	IGUCA2CDirect Screw Platform 11.0 mm height.*Same as DenTack's	Direct Screw Platform (castingabutment) 11.7 mm height*Made of both Titanium & Plastic.Titanium is gingival contact. The Plastichas no body contact.
	Straight Abutment - Similar to Biomet partpresented for DenTack's Straight Abutment(SA), dimensions vary according to gingivalheight.	Straight abutment 1 mm length
	IAPP454GGingiHue© Post 4 mm height(One representative model among others thatvary in gingival height)	Straight abutment 2 mm length
		Straight abutment 3 mm length
		Straight abutment 0.5 mm length
	ICAOO2Certain® Conical Abutment 4.1mm(D) X2mm length	Screw retained abutments 1.5 mm lengthScrew retained abutments 2.5 mm length
Subject	- Reference Predicate Device -Biomet 510(k) K072642	- New Device -DenTack Prostheses
	ILPC342U(One representative model among others thatvary in gingival height)	Straight Multi-unit abutments 2 mmlength
		Straight Multi-unit abutments 3 mmlength
		Straight Multi-unit abutments 4 mmlength
	THA52EP® Healing Abutment 2 mm length.	Healing caps 2 mm length
	THA53EP® Healing Abutment 3 mm length	Healing caps 3 mm length
	THA54EP® Healing Abutment 4 mm length	Healing caps 4 mm length
	N/A – Part of DenTack's implant(designated)	Cover Screw 0.1 mm length
	LAIC1Impression coping.*Same.	Metal housing 3.3 mm height.*Made of SS
	LAERMExtended range males*Same as DenTacks (Plastic).	Plastic cup 2.7 mm height.*Made of Plastic (Nylon)
	ILPC342U(One representative model among others thatvary in gingival height)	Straight Multi-unit Sleeve 10 mm height+ Straight Multi-unit Screw 1.8 mmheight
Materials	Titanium, Titanium alloy, gold, gold alloy,zirconium, vanadium, stainless steel,polyetheretherketone (PEEK), cobaltchromium alloy, and polyoxymethylene(Delrin)	Titanium alloy, stainless-steel andpolymers (nylon)
Sterility	Some are provided sterile and some providednon-sterile and to be sterilized by the user	Non-Sterile (except for the cover screw)
Single Use	Sterile provided: Single use	Single use
Abutment Max.Angle	15°	25°
Connection	Internal and External Hex Connections	Internal Hex Connection

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Image /page/10/Picture/0 description: The image shows the logo for Dentack Implants. The logo features a series of curved lines emanating from a green sphere, followed by the word "DenTack" in a dark blue, serif font. Below "DenTack" is the word "IMPLANTS" in a smaller, sans-serif font.

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Image /page/11/Picture/0 description: The image is a logo for Dentack Implants. The logo features a series of blue arcs that get progressively larger, with a green sphere in the center. To the right of the arcs is the word "DENTACK" in blue, with the word "IMPLANTS" in a smaller font below it.

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Image /page/12/Picture/0 description: The image shows the logo for Dentack Implants. The logo features a series of concentric circles in blue, with a green sphere at the center. To the right of the circles, the word "DENTACK" is written in blue, with the word "IMPLANTS" written in a smaller font size below it.

8. CONCLUSIONS

The DenTack's QUAD dental implants and prostheses, which are the subject of this 510(k) submission, are substantially equivalent to the predicate devices cited above. The device met its requirements and labeling claims per its intended use. The device does not introduce new risks and does not present any new adverse health effects or safety potential risks to patients when used as intended.

Therefore, it was concluded that the overall evaluation of our device performances demonstrates that it is substantially equivalent to the predicate devices.

..............................................................................................................................................................................

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.