DenTack PYRAMIDION 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 conventional, delayed or immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implants in 5-6mm length are indicated for delayed loading only.

Device Description

DenTack has developed a range of expandable dental implants made of titanium (the most common material for dental implants) to serve the need of patients that require partial or complete tooth restoration.

The implant is placed so its 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 are attached to the implant. The PYRAMIDION has an external hex connection with 0.7mm height and 2.7mm hex with a distinct projection externally to the implant body. The connection between the prosthetic part to the upper platform of the implant interacts with a recessed plain of 15-degrees into the upper platform of the implant body while it is projected from the prosthetic part.

All DenTack's implants are made of biocompatible Titanium. Prostheses and Surgical components are made of same Titanium alloy, stainless-steel and polymers.

DenTack's PYRAMIDION Implants with are the subject of this submission are available in outer diameter (OD) of 4.1 mm and in length of 5 and 6 mm.

DenTack's Prostheses and dimension ranges are identified as follows:
Metal Housing: 3.3 mm Height
Plastic Cup: 2.7 mm Height
Straight Multi-Unit Sleeve: 11 mm Height
Straight Multi-Unit Screw: 2.3 mm Diameter
Angled Abutments 15° And 22.5°: Length: 7 mm – 9 mm
Angled Abutments 15° Large: Total Length: 9 mm – 12 mm
Ball Attachments: 2, 3 and 4 mm Height
Direct Screw Platform
Straight Abutments 2, 3, 8.5 mm Length
Straight Multi-Unit Abutments 2, 3 and 4 mm Length
Angled Multi Unit Abutments 17° and 1.5 and 3 mm Length
Healing Caps 3, 4, 5 and 6 mm
Cover Screw

The Direct Screw Platform is to be used with a burn-out plastic sleeve for ensuring a minimum post height of 4 mm (with no angular correction).

Like the QUAD implants cleared under K152188, the subject PYRAMIDION implants expansion is performed using a reusable Expansion Tool and Ratchet Torque).

AI/ML Overview

The provided text is a 510(k) summary for the DenTack PYRAMIDION Dental Implants and Prostheses. It describes the device, its intended use, and comparative testing performed to demonstrate substantial equivalence to predicate devices. However, this document does not describe a study involving an AI/Machine Learning device or its acceptance criteria and performance metrics.

The document primarily focuses on mechanical, physical, and biocompatibility testing of dental implants and prostheses, comparing them to legally marketed predicate devices. It covers aspects like:

Fatigue testing (ISO 14801): To assess durability.
Surface analysis (SEM): To characterize the implant surface.
Implant removal after expansion: To evaluate interaction with artificial bone.
Minimal rotation torque after placement and expansion: To assess stability.
Partially expanded implant reciprocating effect test: To evaluate effects of rotation.
Biocompatibility (ISO 10993): To ensure biological safety.
Sterilization validation (Gamma and Steam): To ensure sterility.
Cleaning validation: For reusable tools.
Shelf life validation: To confirm sterility maintenance over time.
Comparative pull-out test (ASTM F543): To assess mechanical strength.
Comparative bone to implant contact surface area analysis: To compare integration potential.
Implant surface area analysis: For physical characteristics comparison.

Therefore, I cannot provide the requested information regarding AI/ML device acceptance criteria and performance, as the document does not contain any details about an AI/ML component or study.

The questions posed (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone algorithm performance) are highly specific to AI/Machine Learning model validation in a medical context, which is not described in this 510(k) summary for dental implants.

Summary

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

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

December 13, 2018

DenTack Implants Ltd % Tali Hazan Regulatory Consultant Talmed Ltd. M.P Upper Galillee Ramot Naftali, 13830 ISRAEL

Re: K180859

Trade/Device Name: PYRAMIDION Dental Implants and Prostheses Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: November 1, 2018 Received: November 13, 2018

Dear Tali 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. 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/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

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

Indications for Use

510(k) Number (if known) K180859

Device Name

PYRAMIDION 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 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}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Paramidion Implant Solutions. The word "PARAMIDION" is written in blue, with a stylized "lambda" symbol replacing the "A". Below the main word, in a smaller, gray font, are the words "Implant Solutions."

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

DATE PREPARED: DECEMBER 13, 2018

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: PYRAMIDION Dental Implants and Prostheses Classification: DenTack's PYRAMIDION 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	872.3640	Dental

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

3. PREDICATE DEVICES

DenTack's PYRAMIDION Dental Implants and Prostheses are substantially equivalent to the following Predicate Devices:

3.1 Primary Predicate Device: DenTack's OUAD Dental Implants and Prostheses, cleared under 510(k) number K152188 on January 28, 2016.
3.2 Reference Device: Biomet's Biomet 3i T3 Dental Abutments, cleared under 510(k) K072642 on December 20, 2007.
3.3 Reference Device: Bicon's Bicon Implants with A 2.5mm Internal Connection cleared under 510(k) K092035 on October 15, 2009.
3.4 Reference Device: Biomet's Biomet 3i T3 Short implant, cleared under 510(k) K150571 on November 20, 2015.
3.5 Reference Device: Quantum BioEngineering Ltd's Quantum™ Dental Implant System, cleared under 510(k) K112279 on May 01, 2012.

DEVICE DESCRIPTION 4.

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

All DenTack's implants are made of biocompatible Titanium. Prostheses and Surgical components are made of same Titanium alloy, stainless-steel and polymers.

DenTack's PYRAMIDION Implants with are the subject of this submission are available in outer diameter (OD) of 4.1 mm and in length of 5 and 6 mm.

DenTack's Prostheses and dimension ranges are identified as follows:

Metal Housing	3.3 mm Height
Plastic Cup	2.7 mm Height
Straight Multi-Unit Sleeve	11 mm Height
Straight Multi-Unit Screw	2.3 mm Diameter
Angled Abutments 15° And 22.5°	Length: 7 mm – 9 mm
Angled Abutments 15° Large	Total Length: 9 mm – 12 mm
Ball Attachments	2, 3 and 4 mm Height
Direct Screw Platform
Straight Abutments 2, 3, 8.5 mmLength
Straight Multi-Unit Abutments 2, 3and 4 mm Length
Angled Multi Unit Abutments 17°and 1.5 and 3 mm Length
Healing Caps 3, 4, 5 and 6 mm

Cover Screw

The Direct Screw Platform is to be used with a burn-out plastic sleeve for ensuring a minimum post height of 4 mm (with no angular correction).

Like the QUAD implants cleared under K152188, the subject PYRAMIDION implants expansion is performed using a reusable Expansion Tool and Ratchet Torque).

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

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

5. INTENDED USE

PERFORMANCE DATA 6.

A series of safety and performance tests and evaluations were performed to demonstrate that DenTack's PYRAMIDION Dental Implant System does not raise any new issues of safety and effectiveness to support substantial equivalence with the predicate devices. These evaluations include are:

a) Fatigue Test This test was conducted according to ISO 14801 standard 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.
b) Surface analysis The implant surface after surface treatment was tested using the SEM (Scanning Electron Microscope) which is a valid, conventional and known method.
c) Implant Removal after Expansion This comparative test was conducted per DenTack protocol, in order to demonstrate that the expandable design does not cause additional damage to the surrounding tissue.

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

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 OUAD 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 OUAD met the acceptance criteria and performed at least as good as or better than the predicate device.

e) Partially expanded Implant Reciprocating Effect Test -

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.

f) Biocompatibility Biocompatibility was evaluated with accordance to ISO 10993-1 standard for Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, considering exhaustive 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; ISO 10993-12 for Biological evaluation of medical devices - Part 12: Sample preparation and

December 13, 2018

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

reference materials. The chemical and biological tests have not revealed any incompatibility potential or any adverse effect.

Endotoxin testing (LAL test method) conducted per USP <85> to show endotoxins are within acceptable criteria (i.e., not more than 20EU/Device or 0.5EU/mL).

g) Gamma Sterilization Validation Sterilization was conducted with successful results, using Gamma Irradiation according to VDmax method in accordance with ISO 11137-2 for Sterilization of health care products – Radiation - Part 2: Establishing the sterilization dose, and in conjunction with AAMI TIR 33 (recently replaced by 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 non-sterile 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 10-6. IFU (instructions for use) are in-line with the validation results.
i) Cleaning Validation This test was conducted in order to evaluate the cleaning effectiveness before each reuse of reusable tools. The validation was conducted per AAMI TIR 30 standard with successful results.
j) Shelf life validation Was performed with accordance to ISO 11607-1 for 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.
k) Comparative Pull-out Test The test was performed according to the requirements of ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws in comparison with legally marketed device.

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

I) Comparative Bone to Implant Contact Surface Area Analysis - Contact surface area was analyzed in comparison to legally marketed device at worst case implant variation.
m) Implant Surface Area Analysis Implant actual surface area before surface treatment was compared to legally marketed device at worst case implant variation.

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

7. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

DenTack Implants are manufactured from biocompatible Titanium 6Al-4V-ELI and Pure Titanium. Implant surface is treated by an established Titanium 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 predicate devices and shares same methodology as the predicate devices. Both the proposed and predicate devices function in the same manner providing support for prosthetic devices in the upper or lower jaw.

With the exception of the lengths and connection platform DenTack's previously cleared OUAD (K152188) and PYRAMIDION implants are identical. These differences were bridged by reference devices and performance testing. Therefore, it was concluded that they are substantially equivalent.

The comparison of the similarities and differences between PYRAMIDION implant and predicate devices are hereby presented in the tables as follows:

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

PARAMIDION Implant Solutions

ImplantFeature	- Primary PredicateDevice -DenTack's QUADImplant cleared under510(k) K152188	- Reference Device -Bicon Implantscleared under510(k) K092035	- Reference Device -Biomet's3i T3 short implantcleared under 510(k)K150571	- Reference Device -Quantum's dentalimplant systemCleared under 510(k)K112279	- New Device -DenTack'sPYRAMIDION
Intended	DenTack Dental	The Bicon implant is	The 3i T3® ShortImplants are intended	Quantum™, DentalImplant System implants	DenTack
Use	Implants and Prosthesesare intended forsurgical placement inthe maxilla and/or inthe mandible to providea means for prostheticattachment in singletooth restorations and inpartially or fullyedentulous jawsutilizing conventional,delayed or immediateloading; when goodprimary stability isachieved.	designed for use inedentulous sites inthe mandible ormaxilla for supportof a completedenture prosthesis, afinal or intermediateabutment for fixedbridgework or forpartial dentures, oras a single toothreplacement.	for surgical placementin the upper or lowerjaw to provide ameans for prostheticattachment in singletooth restorations andin partially or fullyedentulous spans withmultiple single teethutilizing delayedloading, or with aterminal orintermediary abutmentfor fixed or removablebridgework, and toretain overdentures.	are intended for immediateor delayed placement inthe bone of the maxillaryor mandibular arch.Quantum Dental ImplantSystem abutments areintended for use as supportfor crowns, bridges oroverdentures. When a one-stage surgical approach isapplied, threaded implantmay be immediatelyloaded when good primarystability is achieved andthe functional load isappropriate. Delayedloading is required whenusing the push-intechnique for fin-type orthreaded implants, or whenusing any 5mm or 6mmlength implant.	PYRAMIDION DentalImplants and Prosthesesare intended for surgicalplacement in the maxillaand/or in the mandibleto provide a means forprosthetic attachment insingle tooth restorationsand in partially or fullyedentulous jawsutilizing conventional,delayed or immediateloading when goodprimary stability isachieved and withappropriate occlusalloading. Implants in5-6mm length areindicated for delayedloading only.
ImplantFeature	- Primary PredicateDevice -DenTack's QUADImplant cleared under510(k) K152188	- Reference Device -Bicon Implantscleared under510(k) K092035	- Reference Device -Biomet's3i T3 short implantcleared under 510(k)K150571	- Reference Device -Quantum's dentalimplant systemCleared under 510(k)K112279	- New Device -DenTack'sPYRAMIDION
PatientPopulation	Edentulous or partiallyEdentulous individuals	Edentulous orpartially Edentulousindividuals	Edentulous orpartially Edentulousindividuals	Edentulous or partiallyEdentulous individuals	Edentulous or partiallyEdentulous individuals
Material	Implant body: Titaniumalloy ELI,Implant foils: PureTitanium, unalloyed.	Titanium alloy ELI	Pure titanium	Titanium alloy	Implant body: Titaniumalloy ELI,Implant foils: PureTitanium, unalloyed.
ImplantModel	DenTackPYRAMIDIONexpandable dentalimplants forconventional, delayedor immediate load(7-11mm lengthimplants).	Non-expandableshort implants (5mmlength), not forimmediate loading.	Non-expandable, shortimplants (5-6mmlength) not forimmediate loading.	Non-expandable, shortimplants (5-6mm length)not for immediate loading.	Expandable dentalimplants in 5-6mmlength implants, not forimmediate loading butfor delayed load only.
ImplantDimensions	Length (mm): 7, 8, 9,10 and 11Diameter (mm): 3.75,4.1	Length (mm): 5Diameter (mm): 4	Length (mm): 5, 6Diameter (mm): 5, 6	Length (mm): 5, 6Diameter (mm): 4	Length (mm): 5, 6Diameter (mm): 4.1
Surface	Titanium OxideBlasting and acidetching	Hydroxylapatite(HA)	The implants areoffered with orwithout a nano-scalediscrete crystallinedeposition (DCD®)calcium phosphate	RBM,Acid etch,HA coated	Titanium OxideBlasting and acidetching
ImplantFeature	- Primary PredicateDevice -DenTack's QUADImplant cleared under510(k) K152188	- Reference Device -Bicon Implantscleared under510(k) K092035	- Reference Device -Biomet's3i T3 short implantcleared under 510(k)K150571	- Reference Device -Quantum's dentalimplant systemCleared under 510(k)K112279	- New Device -DenTack'sPYRAMIDION
			(CaP) surfacetreatment.
ImplantsDesign	Apically expandableroot form dentalimplant.	Cylindrical implant	The dental implantsare basic screw-typedesigns available inparallel walled bodygeometries with anexternal hexconnection	Threaded and a grooveddesign	Apically expandableroot form dentalimplant.
ExpansionMechanism	Expansion tool isinserted in the implantupper platform andimplant is expandedusing the ratchet torque.	No expansionmechanism	No expansionmechanism	No expansion mechanism	Expansion tool isinserted in the implantupper platform andimplant is expandedusing the ratchet torque.
Sterility	Sterile by GammaIrradiation	Sterile	Sterile	Sterile	Sterile by GammaIrradiation
Placementmethod	Placing the implantimmediately afterdrilling	Placing the implantimmediately afterdrilling by tapping it	Placing the implantimmediately afterdrilling	Placing the implantimmediately after drilling	Placing the implantimmediately afterdrilling
Self-Tapping	Yes	No	Yes	Yes	Yes
Connectiontype	Internal hex	Internal Hex	External Hex	Internal and External Hex	External hex
ImplantFeature	- Primary PredicateDevice -DenTack's QUADImplant cleared under510(k) K152188	- Reference Device -Bicon Implantscleared under510(k) K092035	- Reference Device -Biomet's3i T3 short implantcleared under 510(k)K150571	- Reference Device -Quantum's dentalimplant systemCleared under 510(k)K112279	- New Device -DenTack'sPYRAMIDION
Maximumabutmentangle	25°	0° (straight)	30°	Up to 25°	22.5°

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

{11}------------------------------------------------

PARAMIDION

Implant Solutions

{12}------------------------------------------------

PARAMIDION

Implant Solutions

{13}------------------------------------------------

PARAMIDION

Implant Solutions

{14}------------------------------------------------

The comparison of the similarities and differences between PYRAMIDION Prostheses and predicate device are hereby presented in the tables below:

AbutmentFeature	- Reference Device -Biomet's 3i T3 Dental Abutmentscleared under 510(k) K072642	- New Device -DenTack's PYRAMIDION
Intended Use	BIOMET 3i Dental Abutments areintendedfor use as accessories to endosseousdental implant to support a prostheticdevice in a partially or completelyedentulous patient. A dental abutmentis intended for use to support single andmultiple tooth prosthesis, in themandible or maxilla. The prosthesiscan be screw retained or cementretained.Restorative Components:• Temporary Healing Abutments areintended for use to shape andmaintain the soft tissue openingduring healing.• Castable restorative componentsare intended for use as accessoriesto endosseous dental implants toaid in the fabrication of dentalprosthetics.• Screw components are intended foruse as accessories to endosseousdental implants for retention ofscrew retained abutments to thedental implant.	Same intended use and clinicalpurpose.
AbutmentFeature	- Reference Device -Biomet's 3i T3 Dental Abutmentscleared under 510(k) K072642	- New Device -DenTack's PYRAMIDION
ItemsIdentificationandDescription	PAP452G, Angled abutment totallength 9 mm 15° angle	Angled Abutment total length 9 mm15° angle
	PAP452G, Angled abutment totallength 9 mm 15° angle	Angled Abutment total length 12 mm15° angle
	IPAP462G, Angled Abutment (AA) 8mm length 15° angle.	Angled Abutment 7.0 mm length22.5° angle
	PAP452G, Angled Abutment totallength 9 mm 15° angle.	Angled Abutment total length 9 mm22.5° angle
	LOA002, Titanium alloy removableoverdentures 2 mm height	Ball attachment abutment 2 mmheight
	LOA003, Titanium alloy removableoverdentures 3 mm height	Ball attachment abutment 3 mmheight
	LOA004, Titanium alloy removableoverdentures 4 mm height	Ball attachment abutment 4 mmheight
	LAIC1, Overdenture metal housing	Metal housing 3.3 mm height.*Made of SS
	LAERM, Extended range males	Plastic cup 2.7 mm height.*Made of Plastic (Nylon)
	UNAB2C, Direct Screw Platform 11.0mm height.	Direct Screw Platform*to be used with burn-out plastic sleeveensuring a minimum post-height of 4mm(with no angular correction)
	APP452G, Straight Abutment varyaccording to gingival height	Straight abutment 2, 3, 8.5 mmlength - Similar to Biomet partpresented for DenTack's SA-xxxEX,dimensions
	APP452G straight abutment 2 mmlength (One representative modelamong others that vary in gingivalheight)	Straight abutment 2, 3 and 8.5 mmlength
	Straight Multi-unit abutments 2 mmlength LPC442U (One representative	Straight Multi-unit abutments 2, 3and 4 mm length
AbutmentFeature	- Reference Device -Biomet's 3i T3 Dental Abutmentscleared under 510(k) K072642	- New Device -DenTack's PYRAMIDION
	model among others that vary ingingival height)
	LPAC4217, 2 mm length, 17º angle	Angled Multi Unit Abutment, 17º angle correction, 1.5 mm length
	LPAC4330, 3 mm length, 17º angle	Angled Multi Unit Abutment, 17º angle correction, 3.0 mm length
	LPCTC2Retaining screw	Straight Multi-unit Sleeve 11 mm height + Straight Multi-unit Screw 2.3 mm
	THA53EP® Healing Abutment 3 mm length	Healing caps 3 mm length
	THA54EP® Healing Abutment 4 mm length	Healing caps 4 mm length
	THA56EP® Healing Abutment 6 mm length	Healing caps 5 and 6mm length
Materials	Titanium, Titanium alloy, gold, goldalloy, zirconium, vanadium, stainlesssteel, polyetheretherketone (PEEK),cobalt chromium alloy, andpolyoxymethylene (Delrin)	Titanium alloy, stainless-steel andpolymers (nylon) not in body contact
Sterility	Some are provided sterile and someprovided non-sterile and to be sterilizedby the user	Non-sterile provided (except for thecover screw). Non-sterile parts are tobe sterilized by the user
Single Use	Single use	Single use
AbutmentMax Angle	15º	22.5º
Connection	Internal and External hex connections	External hex connection

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

{15}------------------------------------------------

{16}------------------------------------------------

{17}------------------------------------------------

8. DISCUSSION AND CONCLUSIONS

The DenTack's PYRAMIDION dental implants and prostheses, which are the subject of this 510(k) submission, are substantially equivalent to the predicate devices cited above. Differences in the length dimensions were bridged using BICON'S reference device (K092035) which is available in the same dimensions. External hex platform of the subject device was bridged by Biomet's reference device cleared under K150571 and was validated through fatigue test. The external hex abutments were supported by Biomet's reference device cleared under K072642.

The difference in using 22.5° angled abutment for 4.1mm diameter PYRAMIDION implants was bridged by Quantum BioEngineering's reference device (Quantum™ Dental Implant System K112279). This device clearance includes angled abutments of 25.5° for implant diameter of 4.0mm. Therefore, is suitable to support DenTack's PYRAMIDION's 25.5° angled abutments for implant diameter of 4.1mm.

The subject device met all 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 substantial equivalent to the selected 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.