The Paltop Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Paltop Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Device Description

Paltop Advanced Dental Solutions Implant System consists of a one and two stage endosseous screw type implant with internal hexagonal connection, intended for single use. Each implant is accompanied by standard cover screws, healing caps, abutment system superstructures and surgical instruments. The Paltop dental implant system is composed of the following implant families: Paltop Advanced screw type implants and Paltop Dynamic screw type implants. Each implant is accompanied by a standard cover screw. Paltop dental implants are made of Ti 6Al 4V ELI, and shall meet the requirements of ASTM F136. "Paltop Advanced" are screw type implants, with double leaded "V" shape progressive external thread profile along the implants body, and fine threads at its neck. It has an internal hex. connection and a domed apex. The implant is available in 3.75mm, 4.2mm and 5mm diameter and lengths of 8mm, 10mm, 11.5mm, 13mm and 16mm. The implants are suitable for both one and two stage implant procedures. "Paltop Dynamic" are screw type implants, with 3 different thread geometries: double leaded "V" shape progressive external thread profile at the apical portion, modified reverse buttress along its body and fine thread at the neck. It has an internal hex. connection. The implant is available in 3.75mm, 4.2mm and 5mm diameter and lengths of 8mm, 10mm, 11.5mm, 13mm and 16mm. The implants are suitable for both one and two stage implant procedures. The Paltop Advanced Dental Implant System includes a variety of abutments having a central bore and a lower mating surface that is configured to mate with the mating surface of the Paltop implant. A collar portion is located at a coronal end of the dental implant. A central bore extends through the collar portion and into the implant body portion. The central bore includes a threaded section for receiving a threaded portion of a screw and post receiving section. The post receiving section consists of hex geometry for antirotational features and a conical section (above the hex) which interfaces with the abutment. The designed threads provides secure primary fixation. This design is responsible for transferring the load from the abutment/prosthesis to the implant body.

AI/ML Overview

The provided document is a 510(k) summary for the Paltop Advanced Dental Solutions Implant System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data for acceptance criteria.

Therefore, the document does not contain a detailed study proving the device meets specific acceptance criteria in the format requested by the user for an AI/ML device.

Here's a breakdown of the available information in relation to the requested points:

1. A table of acceptance criteria and the reported device performance

This information is not explicitly provided in the document in the context of acceptance criteria and performance metrics typically expected for an AI/ML device. The document primarily focuses on demonstrating substantial equivalence to predicate dental implants through technological characteristics and compliance with established standards for dental implants.

The "performance" described is in the context of mechanical, material, and biological properties, not a predictive or diagnostic AI/ML performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The non-clinical tests mentioned are fatigue, corrosion resistance, surface analysis, and biocompatibility, which are standard tests for physical medical devices, not AI/ML systems.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and therefore not provided. The device described is a dental implant, not an AI/ML diagnostic or predictive tool that requires expert-established ground truth from images or other data.

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

This information is not applicable and therefore not provided. As the device is a physical dental implant, there is no "test set" in the context of AI/ML performance evaluation requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable and therefore not provided. The device is a dental implant and does not involve AI assistance for human readers/clinicians, nor does it present "cases" for interpretation.

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

This information is not applicable and therefore not provided. The device is a physical dental implant and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable in the context of AI/ML ground truth. For the physical dental implant, ground truth is implicitly established by compliance with international standards for material properties, mechanical performance (e.g., fatigue), and biocompatibility. Clinical effectiveness is generally inferred from the substantial equivalence to existing devices with a long history of safe and effective use.

8. The sample size for the training set

This information is not applicable and therefore not provided. The device is a physical dental implant and does not involve a training set for an AI/ML algorithm.

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

This information is not applicable and therefore not provided. The device is a physical dental implant and does not involve a training set for an AI/ML algorithm.

Summary regarding the provided document:

The 510(k) submission for the Paltop Advanced Dental Solutions Implant System focuses on demonstrating substantial equivalence to predicate dental implant devices, as opposed to providing detailed acceptance criteria and a study for an AI/ML device. The "study" referenced in the document for clinical aspects is a literature review, which concludes that titanium-based dental implants are safe and effective. The "acceptance criteria" are implied by compliance with various international standards for biocompatibility, material properties, and mechanical performance relevant to dental implants (e.g., ISO, ASTM standards listed on pages 4, 6, and 7). There are no AI/ML specific details in this document.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Advanced Dental Solutions Ltd. The logo features a stylized tooth inside of a circle on the left. To the right of the tooth is the company name, "Advanced Dental Solutions Ltd." in a small, sans-serif font. Below the company name is the word "PALTOP" in a larger, stylized font.

With you to the TOT

APR 2 0 2012

510(k) Number K_1 <

510(k) SUMMARY

5.1 Applicants Name: Paltop Advanced Dental Solutions Ltd. Hashita 5 Industrial Park Caesarea 30889, Israel T +972 4 6271711 F +972 4 6275363 Tal Hammer-Topaz 5.2 Contact Person: Quality, Regulatory & Clinical Manager Paltop Advanced Dental Solutions Ltd. Hashita 5

Industrial Park Caesarea 30889, Israel T +972 5 23 520050 F +972 4 6275363 Email: tal@paltopdental.com

5.3 Date Prepared:	August 2011
5.4 Trade Name:	Paltop Advanced Dental Solution System
5.5 Classification Name:	Implant, Endosseous, Root-form
5.6 Common usual name:	Dental Implant
5.7 Medical Specialty:	Dental
5.8 Product Code:	DZE, NHA
5.9 Device Class:	Class II
5.10 Regulation Number:	872.3640
5.11 Review Panel:	Dental Device Panel

5.12 Predicate Devices:

Alpha-Bio Tec Dental Implant System (Alpha Bio Tec Ltd.) cleared under K063364; . product code DZE (Implant, Endosseous, Root-form).
MIS Dental Implant System (MIS Implant Technologies Ltd.) cleared under K040807; . product code DZE (Implant, Endosseous, Root-form).

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Image /page/1/Picture/0 description: The image shows the logo for Advanced Dental Solutions Ltd. The logo features a stylized tooth graphic on the left, followed by the word "PALTOP" in a bold, geometric font. The company name, "Advanced Dental Solutions Ltd.", is printed in smaller font above the "PALTOP" logo.

With you to the TOP

Osseospeed TM Profile System (ASTRA Tech AB) cleared under K080156, K091239) ; . product code DZE (Implant, Endosseous, Root-Form)
ARSD Dental Implants (ARDS Ltd.) cleared under K071803 ;product code DZE (Implant, . Endosseous, Root-Form)
NobleActive internal Connection Implant (Nobel Biocare AB) cleared under K071370; . product code DZE (Implant, Endosseous, Root-Form); producț code NHA (Abutment, Implant, Dental, Endosseous).

5.13 Intended Use / Indication for Use:

The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Paltop Dental Advanced Dental Implant Solutions System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

5.14 Device Description:

The Paltop dental implant system is composed of the following implant families: Paltop Advanced screw type implants and Paltop Dynamic screw type implants. Each implant is accompanied by a standard cover screw. Paltop dental implants are made of Ti 6Al 4V ELI, and shall meet the requirements of ASTM F136.

"Paltop Advanced" are screw type implants, with double leaded "V" shape progressive external thread profile along the implants body, and fine threads at its neck. It has an internal hex. connection and a domed apex. The implant is available in 3.75mm, 4.2mm and 5mm diameter and lengths of 8mm, 10mm, 11.5mm, 13mm and 16mm (as detailed in Table 2: System Components). The implants are suitable

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Image /page/2/Picture/0 description: The image shows the logo for Advanced Dental Solutions Ltd. The logo features a stylized tooth inside a circle on the left. To the right of the tooth is the word "PALTOP" in a bold, sans-serif font, with a registered trademark symbol next to the "P" on the right.

for both one and two stage implant procedures.

"Paltop Dynamic" are screw type implants, with 3 different thread geometries: double leaded "V" shape progressive external thread profile at the apical portion, modified reverse buttress along its body and fine thread at the neck. It has an internal hex. connection. The implant is available in 3.75mm, 4.2mm and 5mm diameter and lengths of 8mm, 10mm, 11.5mm, 13mm and 16mm (as detailed in Table 2: System Components). The implants are suitable for both one and two stage implant procedures.

The Paltop Advanced Dental Implant System includes a variety of abutments having a central bore and a lower mating surface that is configured to mate with the mating surface of the Paltop implant.

A collar portion is located at a coronal end of the dental implant. A central bore extends through the collar portion and into the implant body portion. The central bore includes a threaded section for receiving a threaded portion of a screw and post receiving section. The post receiving section consists of hex geometry for antirotational features and a conical section (above the hex) which interfaces with the abutment. The designed threads provides secure primary fixation. This design is responsible for transferring the load from the abutment/prosthesis to the implant body.

5.14 Substantial Equivalence:

The proposed Paltop Advanced Dental Solutions Implant System has similar indications for use, technological characteristics, mode of operation and performance specification as the predicates Alpha-Bio Tec Dental Implant System (K063364), MIS Dental Implant System (K040807), ARSD Dental Implants (K071803), Osseospeed™ Profile System (K080156, K091239) and NobleActive internal Connection Implant (K071370).

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Image /page/3/Picture/0 description: The image shows the logo for Advanced Dental Solutions Ltd. The logo features a stylized tooth graphic to the left of the text "PALTOP". Below the company name is the tagline "With you to the TOP".

The proposed device has the same intended use as the predicate Alpha-Bio Tec " Dental Implant System and MIS Dental Implant System and is placed using the 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.

Technological Characteristics – comparative table

K#	Paltop Implant System	Alpha-Bio Tec® Dental Implant System	MIS Dental Implant System
		Cleared under K#063364	Cleared under K#040807
ProductCode	DZE	DZE	DZE
Manufacturer	Paltop Advanced DentalSolutions Ltd.	Alpha-Bio Tec Ltd.	MIS Implant Technologies Ltd.
IntendedUse/Indications forUse	The Paltop Dental ImplantSystem is indicated for usein surgical and restorativeapplications for placementin the bone of the upper orlower jaw to providesupport for prostheticdevices, such as artificialteeth, in order to restorethe patient's chewingfunction. The Paltop DentalImplant System is indicatedalso for immediate loadingwhen good primary stabilityis achieved and withappropriate occlusalloading.	The Alpha-Bio Dental Implant System® isindicated for use in surgical andrestorative applications for placement inthe bone of the upper or lower jaw toprovide support for prosthetic devices,such as artificial teeth, in order to restorethe patient's chewing function. TheAlpha-Bio Dental Implant System®isindicated also for immediate loadingwhen good primary stability is achievedand with appropriate occlusal loading.	The MIS Dental Implant System isindicated for use in surgical andrestorative applications for placement inthe bone of the upper or lower jaw toprovide support for prosthetic devices,such as artificial teeth, in order to restorethe patient's chewing function.
Limitations onIndications/Contraindications/RelativeContraindications	Serious internal medicalproblems, bonemetabolism disturbances,uncontrolled bleedingdisorders, inadequatewound healing capacity,poor oral hygiene, maxillaryand mandibular growth notcompleted, poor generalstate of health,uncooperative,unmotivated patient, drugor alcohol abuse,psychoses, prolongedtherapy-resistant functionaldisorders, xerostomia,weakened immune system,illnesses requiring periodicuse of steroids, titaniumallergy, uncontrollableendocrine disorders.Relative contraindications:Previously irradiated bone,	Patients who take steroid based,anticonvulsant and anticoagulant drugs.Patients receiving radiotherapy,chmotherapy or any otherimmunosuppressive treatment or whohave been administered radiotherapy inthe past 5 years. Metabolic bonedisorders, uncontrolled bleedingdisorders such as: hemophilia,thrombocytopenia, granulocytopeniadiseases,Degenerative diseases,osteoradionecrosis, renal failure, organtransplant recipients, AIDS, malignantdiseases, diseases that compromise theimmune system, unbalanced diabetesmellitus, psychotic diseases,hypersensitivity to one of thecomponents of the implant ingeneral andtitanium in particular, pregnancy,inability of the patient to maintainreasonable oral hygeine, lack of patientcooperation, use of alcohol, narcoticsand uncontrolled endocrine disease. Anysystemic condition that is unbalanced	The contraindications customary in oralsurgery with other implant materialsshould be observed. These includepatiens on corticosteroids,anticoagulants or anticonvulsant andthose receiving radiation or otherimmunosupressive therapy. Lactating orpregnant woman are not candidates, norare patients with abnormal laboratoryvalues for BUN, creatinine or serumcalcium. Patients with diabetes orcardiovascular disease arecontraindicated. Hypertension above110/170mmHG, osteoportic crushfractures, respiratory disease, thyroid orparathyroid disease should be excludedfrom treatment. Patients with dlagnosedmalignancy in the past five years andthose with nodular enlargementstenderness or unexplained lumps ormasses of the head or neck should not betreated. Implanting procedures shouldnot be performed on persons with activeosteolitic, inflammatory or infectious

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Image /page/4/Picture/0 description: The image shows the logo for Advanced Dental Solutions Ltd. The logo features a stylized tooth inside of a circle on the left. To the right of the tooth is the company name, "Advanced Dental Solutions Ltd.", above the word "PALTOP" in a stylized font.

With you to the TOP

With you to the TOP					4Vanadium ELI (Extra LowInterstitial) Alloy forSurgical ImplantApplications.	UL 544 (1998):, Standard for Medical andDental Equipment - Ed. 4.0.
	anticoagulationdrugs/hemorrhagicdiatheses, bruxism,parafunctional habits,unfavorable anatomic boneconditions, tobacco abuse,uncontrolled periodontitis,temporomandibular jointdisorders, treatablepathologic diseases of thejaw and changes in the oralmucosa, pregnancy,inadequate oral hygiene	and therefore precludes surgicalprocedures. Relative contraindications:Previously irradiated bone, treatmentwith anticoagulant drugs orbisphosphonates, bruxism,parafunctional habits, untreated and/oruncontrolled periodontal disease,temporomandibular joint disease, varouspathologies of the oral mucosa.	processed in the implantation site. Thefolloiwng outline lists thecontraindications:Debilitating or uncontrolled disease;pregnance, hemophilia;granulocytopenia or other bleedingproblems, steroid use, prophylacticantibiotics, britlle diabetes, Ehler-Danlossyndrome; osteoradionecrosis, renalfailure, organ transplanationanticoagulation therapy; unexplainedhypersensitivity, fibrous dysplasis,regional enteritis.		5. ASTM F899 StandardSpecification for WroughtStainless Steels for SurgicalInstruments.
UserPopulation	Adult and young patientswho have been screened toascertain that there issufficient alveolar bonewidth to support theimplant. In general anyonehealthy enough to undergoroutine tooth extraction ororal surgery is probablyable to receive an implant.	Adult and young patients who have beenscreened to ascertain that there issufficient alveolar bone width to supportthe implant. In general anyone healthyenough to undergo routine toothextraction or oral surgery is probablyable to receive an implant.	Adult and young patients who have beenscreened to ascertain that there issufficient alveolar bone width to supportthe implant. In general anyone healthyenough to undergo routine toothextraction or oral surgery is probablyable to receive an implant.		6. ASTM F746-04(Reapproved 2009)Standard Test Method forPitting or Crevice Corrosionof Metallic Surgical ImplantMaterials.
Components	The Paltop AdvancedDental Solutions ImplantSystem consists of one andtwo stage endosseous formdental implants, internalhexagonal connection;cover screws and healingcaps; abutment systemsand superstructures;surgical instruments.	The Alpha-Bio Dental Implant System®consists of one and two stageendosseous form dental implants,internal and external hexagonal; internaloctagonal hexagonal; one piece implantssystem; cover screws and healing caps;abutment systems and superstructures;surgical instruments.	The MIS Dental Implant System consistsof one and two stage implants, internaland external hexagonal; cover screw andhealing caps; abutment systems andsuprastructures; surgical instruments.		7. ISO 10993-1:2003Biological evaluation ofmedical devices - Part 1:Evaluation and testing.
Accessories	Surgical Instruments	Surgical Instruments	Surgical Instruments		8. ISO 14971:2007 - RiskAnalysis for Medical Device.
IntendedUseEnvironment	Dental Clinic Setting	Dental Clinic Setting	Dental Clinic Setting		9. ISO 9001:2008 - Qualitymanagement systemsrequirements.
ClinicalData	N/A	No information was provided in the 510Knotice.	No information was provided in the 510Knotice.		10. ISO 13485:2003(including CMDCAS MedicalDevice Regulations) -Quality systems medicaldevices.
Standards withwhich theDeviceComplies	Specification for Wrought Titanium-6Aluminum-	1. FDA Guidance - Class IISpecial Controls GuidanceDocument: Root-formEndosseous DentalImplants and EndosseousDental Implant Abutments.2. ISO 14801:2007"Dentistry-Implants-Dynamic fatigue test forendosseous dentalimplants".3. ISO 5832-3:1996Implants for surgeryMetallic materials Part 3:Wrought titanium 6-aluminium 4-vanadiumalloy.4. ASTM F136 Standard	autoclaving, corrosion and thermal exposure.	ISO 7405:1997, Dentistry- PreclinicalEvaluation of Biocompatibility of MedicalDevices Used in Dentistry - Test Methodsfor DentalF136-02a: 2004 Standard Specificationfor WroughtTitanium-6Alumninum-4Vanadium ELI(Extra LowInterstitial) Alloy for Surgical ImplantApplications (UNSR56401).ASTM F1350-02, 2002 StandardSpecification for Wrought 18 Chromium-14Nickel-2.5 Molybdenum Stainless SteelSurgical Fixation Wire (UNS S31673). ISO13402:1995, Surgical and dental handinstruments --Determination of resistance againstautoclaving corrosion and thermal	ASTM F67-95ISO 9001:2000ISO 13485:2003		11. ISO 11137:2006Sterilization of health careproducts - Radiation -- Part1: Requirements fordevelopment, validationand routine control of asterilization process formedical devices.
	12. ISO 11607: Packagingfor terminally sterilizedmedical devices -- Part 1:Requirements for materials,sterile barrier systems andpackaging systems.
	13. ISO 15223:2000:Medical Devices - Symbolsto be used with medicaldevice labels, labeling andInformation to be supplied.
TechnologicalCharacteristics	3.75mm, 4.2mm, 5mmLengths: 8, 10, 11.5, 13,16m	Material composition:Titanium alloySurface treatment:Sandblasting"aluminum oxideparticles" and AcidEtching HCl & H₂SO₄Dimensions/angulations1. Implants: Diameter3.75mm, 4.2mm, 5mm	Internal hex connection	Material composition: TitaniumAlloySurface treatment: Sandblasting"aluminum oxide particles" and AcidEtching HCl & H₂SO₄Dimensions/angulations1. Implants: Diameter: 3.75 – 6mm,Lengths: 8, 10, 11.5, 13, 16mm2. Abutments 15° - 25°, Diameter 3.9 -4.5mm, Lengths: gum height 1-4mm	Diameter 3.75:8, 10,11.5, 13, 16mm	Material composition: TitaniumAlloySurface treatment: Sandblasting"aluminum oxide particles" and AcidEtching HCl & H₂SO₄Dimensions/angulations1. Implants: Diameter: 3.25-6mm,Lengths:Diameter 3.3:10,11.5, 13, 16mmDiameter 3.75:
2. Abutments 15° - 25°		Diameter 4.2:6, 8, 10,11.5, 13, 16mm

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Image /page/5/Picture/0 description: The image shows the logo for Advanced Dental Solutions Ltd. The logo features a stylized tooth inside a circle on the left. To the right of the circle is the word "PALTOP" in a bold, sans-serif font.

With you to the TOP

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Image /page/6/Picture/0 description: The image shows the logo for Advanced Dental Solutions Ltd. The logo features a stylized tooth icon on the left, followed by the text "PALTOP" in a bold, sans-serif font. The word "PALTOP" also has a trademark symbol next to it.

With you to the TOP

Diameter 4-5.5mm,Lengths: gum height 1-3mmInternal HexConnection	Diameter 5 & 6:6, 8, 10,11.5, 13, 16mm2. Abutments: 15° - 25°, Diameter 4-5.5mm, Lengths: gum height 1-4mmInternal hex connection
----------------------------------------------------------------------------------	---------------------------------------------------------------------------------------------------------------------------------------------------

The Paltop Dental Implant System has the following similarities to predicate devices:

Has the same intended use ●
Uses the same operating principle .
Incorporates the same basic design .
Incorporates the same materials .
Has similar packaging .
Is sterilized using the same procedures .

Non Clinical Tests:

A series of safety and performance testing were performed to demonstrate that the Paltop Advanced Dental Solutions Implant System does not raise any new issues of safety and efficacy. These tests include: fatigue, corrosion resistance, surface analysis and biocompatibility.

The device complies with the following standards:

1. FDA Guidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.
.2. ISO 14801:2007 "Dentistry Implants Dynamic fatigue test for endosseous dental implants".
1. ISO 5832-3:1996 Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy.
1. ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.
1. ASTM F899 Standard Specification for Wrought Stainless Steels for Surgical Instruments
1. ISO 7405:2008 Dentistry -- Evaluation of biocompatibility of medical devices used in dentistry.
1. ASTM F746 04(2009) Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials.

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Image /page/7/Picture/0 description: The image shows the logo for Advanced Dental Solutions Ltd. The logo features a stylized tooth graphic on the left, followed by the word "PALTOP" in a modern, geometric font. A small registration mark is visible to the upper right of the "P" in "PALTOP".

With you to the TOP

1. ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process.
  All these tests demonstrate that the Paltop Advanced Dental Solutions Implant System is substantially equivalent to its predicates without raising new issues of safety or effectiveness.

Clinical Tests

A clinical evaluation has been performed based on a literature review.

From current knowledge this literature evaluation of the Paltop Dental Implant System provides sufficient evidence:

The presented studies demonstrate that titanium-based dental implants can be . installed safely in human patients with a very high overall success rate.
The present studies demonstrate compliance of the device in question with the . essential requirements (in particular regarding safety and performance) under normal conditions of use.
That the device performs as intended by the manufacturer; �
That the device does not pose any undue safety concerns to either the recipient . or end-user.
That any risks associated with the use of the device are acceptable when . weighed against the benefits to the patient.

Summary:

Based on performance testing results, and compliance to performance standards Paltop Advanced Dental Solutions Ltd. believes that the Implant System is substantially equivalent to its predicates without raising new issues of safety or effect

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a person embracing another, representing health and human services.

Public Health Service

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

Ms. Tal Hammer-Topaz Quality, Regulatory & Clinical Manager Paltop Advanced Dental Solutions Ltd. 5 Hashita Street Caesarea ISRAEL 30889

Re: K112795

Trade/Device Name: Paltop Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: March 28, 2012 Received: April 9, 2012

Dear Ms. Hammer-Topaz:

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.

APR 2 0 2012

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Page 2 – Ms. Hammer-Topaz

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, 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): K12795

Device Name: PALTOP Advanced Dental Solutions System

Indications for Use:

Prescription Use > AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)

	Concurrence of CDRH, Office of Device Evaluation (ODE)

	(Division Sign-Off)
	Division of Anesthesiology, General HospitalInfection Control, Dental Devices
510(k) Premarket Notification	510(k) Number:/ 12112795 page.4-2

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With you to the TOT

APR 2 0 2012

510(k) Number K_1 <

510(k) SUMMARY

Industrial Park Caesarea 30889, Israel T +972 5 23 520050 F +972 4 6275363 Email: tal@paltopdental.com

5.3 Date Prepared:	August 2011
5.4 Trade Name:	Paltop Advanced Dental Solution System
5.5 Classification Name:	Implant, Endosseous, Root-form
5.6 Common usual name:	Dental Implant
5.7 Medical Specialty:	Dental
5.8 Product Code:	DZE, NHA
5.9 Device Class:	Class II
5.10 Regulation Number:	872.3640
5.11 Review Panel:	Dental Device Panel

5.12 Predicate Devices:

Alpha-Bio Tec Dental Implant System (Alpha Bio Tec Ltd.) cleared under K063364; . product code DZE (Implant, Endosseous, Root-form).
MIS Dental Implant System (MIS Implant Technologies Ltd.) cleared under K040807; . product code DZE (Implant, Endosseous, Root-form).

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With you to the TOP

Osseospeed TM Profile System (ASTRA Tech AB) cleared under K080156, K091239) ; . product code DZE (Implant, Endosseous, Root-Form)
ARSD Dental Implants (ARDS Ltd.) cleared under K071803 ;product code DZE (Implant, . Endosseous, Root-Form)
NobleActive internal Connection Implant (Nobel Biocare AB) cleared under K071370; . product code DZE (Implant, Endosseous, Root-Form); producț code NHA (Abutment, Implant, Dental, Endosseous).

5.13 Intended Use / Indication for Use:

5.14 Device Description:

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for both one and two stage implant procedures.

The Paltop Advanced Dental Implant System includes a variety of abutments having a central bore and a lower mating surface that is configured to mate with the mating surface of the Paltop implant.

5.14 Substantial Equivalence:

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Technological Characteristics – comparative table

K#	Paltop Implant System	Alpha-Bio Tec® Dental Implant System	MIS Dental Implant System
		Cleared under K#063364	Cleared under K#040807
ProductCode	DZE	DZE	DZE
Manufacturer	Paltop Advanced DentalSolutions Ltd.	Alpha-Bio Tec Ltd.	MIS Implant Technologies Ltd.
IntendedUse/Indications forUse	The Paltop Dental ImplantSystem is indicated for usein surgical and restorativeapplications for placementin the bone of the upper orlower jaw to providesupport for prostheticdevices, such as artificialteeth, in order to restorethe patient's chewingfunction. The Paltop DentalImplant System is indicatedalso for immediate loadingwhen good primary stabilityis achieved and withappropriate occlusalloading.	The Alpha-Bio Dental Implant System® isindicated for use in surgical andrestorative applications for placement inthe bone of the upper or lower jaw toprovide support for prosthetic devices,such as artificial teeth, in order to restorethe patient's chewing function. TheAlpha-Bio Dental Implant System®isindicated also for immediate loadingwhen good primary stability is achievedand with appropriate occlusal loading.	The MIS Dental Implant System isindicated for use in surgical andrestorative applications for placement inthe bone of the upper or lower jaw toprovide support for prosthetic devices,such as artificial teeth, in order to restorethe patient's chewing function.
Limitations onIndications/Contraindications/RelativeContraindications	Serious internal medicalproblems, bonemetabolism disturbances,uncontrolled bleedingdisorders, inadequatewound healing capacity,poor oral hygiene, maxillaryand mandibular growth notcompleted, poor generalstate of health,uncooperative,unmotivated patient, drugor alcohol abuse,psychoses, prolongedtherapy-resistant functionaldisorders, xerostomia,weakened immune system,illnesses requiring periodicuse of steroids, titaniumallergy, uncontrollableendocrine disorders.Relative contraindications:Previously irradiated bone,	Patients who take steroid based,anticonvulsant and anticoagulant drugs.Patients receiving radiotherapy,chmotherapy or any otherimmunosuppressive treatment or whohave been administered radiotherapy inthe past 5 years. Metabolic bonedisorders, uncontrolled bleedingdisorders such as: hemophilia,thrombocytopenia, granulocytopeniadiseases,Degenerative diseases,osteoradionecrosis, renal failure, organtransplant recipients, AIDS, malignantdiseases, diseases that compromise theimmune system, unbalanced diabetesmellitus, psychotic diseases,hypersensitivity to one of thecomponents of the implant ingeneral andtitanium in particular, pregnancy,inability of the patient to maintainreasonable oral hygeine, lack of patientcooperation, use of alcohol, narcoticsand uncontrolled endocrine disease. Anysystemic condition that is unbalanced	The contraindications customary in oralsurgery with other implant materialsshould be observed. These includepatiens on corticosteroids,anticoagulants or anticonvulsant andthose receiving radiation or otherimmunosupressive therapy. Lactating orpregnant woman are not candidates, norare patients with abnormal laboratoryvalues for BUN, creatinine or serumcalcium. Patients with diabetes orcardiovascular disease arecontraindicated. Hypertension above110/170mmHG, osteoportic crushfractures, respiratory disease, thyroid orparathyroid disease should be excludedfrom treatment. Patients with dlagnosedmalignancy in the past five years andthose with nodular enlargementstenderness or unexplained lumps ormasses of the head or neck should not betreated. Implanting procedures shouldnot be performed on persons with activeosteolitic, inflammatory or infectious

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With you to the TOP					4Vanadium ELI (Extra LowInterstitial) Alloy forSurgical ImplantApplications.	UL 544 (1998):, Standard for Medical andDental Equipment - Ed. 4.0.
	anticoagulationdrugs/hemorrhagicdiatheses, bruxism,parafunctional habits,unfavorable anatomic boneconditions, tobacco abuse,uncontrolled periodontitis,temporomandibular jointdisorders, treatablepathologic diseases of thejaw and changes in the oralmucosa, pregnancy,inadequate oral hygiene	and therefore precludes surgicalprocedures. Relative contraindications:Previously irradiated bone, treatmentwith anticoagulant drugs orbisphosphonates, bruxism,parafunctional habits, untreated and/oruncontrolled periodontal disease,temporomandibular joint disease, varouspathologies of the oral mucosa.	processed in the implantation site. Thefolloiwng outline lists thecontraindications:Debilitating or uncontrolled disease;pregnance, hemophilia;granulocytopenia or other bleedingproblems, steroid use, prophylacticantibiotics, britlle diabetes, Ehler-Danlossyndrome; osteoradionecrosis, renalfailure, organ transplanationanticoagulation therapy; unexplainedhypersensitivity, fibrous dysplasis,regional enteritis.		5. ASTM F899 StandardSpecification for WroughtStainless Steels for SurgicalInstruments.
UserPopulation	Adult and young patientswho have been screened toascertain that there issufficient alveolar bonewidth to support theimplant. In general anyonehealthy enough to undergoroutine tooth extraction ororal surgery is probablyable to receive an implant.	Adult and young patients who have beenscreened to ascertain that there issufficient alveolar bone width to supportthe implant. In general anyone healthyenough to undergo routine toothextraction or oral surgery is probablyable to receive an implant.	Adult and young patients who have beenscreened to ascertain that there issufficient alveolar bone width to supportthe implant. In general anyone healthyenough to undergo routine toothextraction or oral surgery is probablyable to receive an implant.		6. ASTM F746-04(Reapproved 2009)Standard Test Method forPitting or Crevice Corrosionof Metallic Surgical ImplantMaterials.
Components	The Paltop AdvancedDental Solutions ImplantSystem consists of one andtwo stage endosseous formdental implants, internalhexagonal connection;cover screws and healingcaps; abutment systemsand superstructures;surgical instruments.	The Alpha-Bio Dental Implant System®consists of one and two stageendosseous form dental implants,internal and external hexagonal; internaloctagonal hexagonal; one piece implantssystem; cover screws and healing caps;abutment systems and superstructures;surgical instruments.	The MIS Dental Implant System consistsof one and two stage implants, internaland external hexagonal; cover screw andhealing caps; abutment systems andsuprastructures; surgical instruments.		7. ISO 10993-1:2003Biological evaluation ofmedical devices - Part 1:Evaluation and testing.
Accessories	Surgical Instruments	Surgical Instruments	Surgical Instruments		8. ISO 14971:2007 - RiskAnalysis for Medical Device.
IntendedUseEnvironment	Dental Clinic Setting	Dental Clinic Setting	Dental Clinic Setting		9. ISO 9001:2008 - Qualitymanagement systemsrequirements.
ClinicalData	N/A	No information was provided in the 510Knotice.	No information was provided in the 510Knotice.		10. ISO 13485:2003(including CMDCAS MedicalDevice Regulations) -Quality systems medicaldevices.
Standards withwhich theDeviceComplies	Specification for Wrought Titanium-6Aluminum-	1. FDA Guidance - Class IISpecial Controls GuidanceDocument: Root-formEndosseous DentalImplants and EndosseousDental Implant Abutments.2. ISO 14801:2007"Dentistry-Implants-Dynamic fatigue test forendosseous dentalimplants".3. ISO 5832-3:1996Implants for surgeryMetallic materials Part 3:Wrought titanium 6-aluminium 4-vanadiumalloy.4. ASTM F136 Standard	autoclaving, corrosion and thermal exposure.	ISO 7405:1997, Dentistry- PreclinicalEvaluation of Biocompatibility of MedicalDevices Used in Dentistry - Test Methodsfor DentalF136-02a: 2004 Standard Specificationfor WroughtTitanium-6Alumninum-4Vanadium ELI(Extra LowInterstitial) Alloy for Surgical ImplantApplications (UNSR56401).ASTM F1350-02, 2002 StandardSpecification for Wrought 18 Chromium-14Nickel-2.5 Molybdenum Stainless SteelSurgical Fixation Wire (UNS S31673). ISO13402:1995, Surgical and dental handinstruments --Determination of resistance againstautoclaving corrosion and thermal	ASTM F67-95ISO 9001:2000ISO 13485:2003		11. ISO 11137:2006Sterilization of health careproducts - Radiation -- Part1: Requirements fordevelopment, validationand routine control of asterilization process formedical devices.
	12. ISO 11607: Packagingfor terminally sterilizedmedical devices -- Part 1:Requirements for materials,sterile barrier systems andpackaging systems.
	13. ISO 15223:2000:Medical Devices - Symbolsto be used with medicaldevice labels, labeling andInformation to be supplied.
TechnologicalCharacteristics	3.75mm, 4.2mm, 5mmLengths: 8, 10, 11.5, 13,16m	Material composition:Titanium alloySurface treatment:Sandblasting"aluminum oxideparticles" and AcidEtching HCl & H₂SO₄Dimensions/angulations1. Implants: Diameter3.75mm, 4.2mm, 5mm	Internal hex connection	Material composition: TitaniumAlloySurface treatment: Sandblasting"aluminum oxide particles" and AcidEtching HCl & H₂SO₄Dimensions/angulations1. Implants: Diameter: 3.75 – 6mm,Lengths: 8, 10, 11.5, 13, 16mm2. Abutments 15° - 25°, Diameter 3.9 -4.5mm, Lengths: gum height 1-4mm	Diameter 3.75:8, 10,11.5, 13, 16mm	Material composition: TitaniumAlloySurface treatment: Sandblasting"aluminum oxide particles" and AcidEtching HCl & H₂SO₄Dimensions/angulations1. Implants: Diameter: 3.25-6mm,Lengths:Diameter 3.3:10,11.5, 13, 16mmDiameter 3.75:
2. Abutments 15° - 25°		Diameter 4.2:6, 8, 10,11.5, 13, 16mm

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Diameter 4-5.5mm,Lengths: gum height 1-3mmInternal HexConnection	Diameter 5 & 6:6, 8, 10,11.5, 13, 16mm2. Abutments: 15° - 25°, Diameter 4-5.5mm, Lengths: gum height 1-4mmInternal hex connection
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The Paltop Dental Implant System has the following similarities to predicate devices:

Has the same intended use ●
Uses the same operating principle .
Incorporates the same basic design .
Incorporates the same materials .
Has similar packaging .
Is sterilized using the same procedures .

Non Clinical Tests:

The device complies with the following standards:

1. FDA Guidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.
.2. ISO 14801:2007 "Dentistry Implants Dynamic fatigue test for endosseous dental implants".
1. ISO 5832-3:1996 Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy.
1. ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.
1. ASTM F899 Standard Specification for Wrought Stainless Steels for Surgical Instruments
1. ISO 7405:2008 Dentistry -- Evaluation of biocompatibility of medical devices used in dentistry.
1. ASTM F746 04(2009) Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials.

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1. ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process.
  All these tests demonstrate that the Paltop Advanced Dental Solutions Implant System is substantially equivalent to its predicates without raising new issues of safety or effectiveness.

Clinical Tests

A clinical evaluation has been performed based on a literature review.

From current knowledge this literature evaluation of the Paltop Dental Implant System provides sufficient evidence:

The presented studies demonstrate that titanium-based dental implants can be . installed safely in human patients with a very high overall success rate.
The present studies demonstrate compliance of the device in question with the . essential requirements (in particular regarding safety and performance) under normal conditions of use.
That the device performs as intended by the manufacturer; �
That the device does not pose any undue safety concerns to either the recipient . or end-user.
That any risks associated with the use of the device are acceptable when . weighed against the benefits to the patient.

Summary:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Ms. Tal Hammer-Topaz Quality, Regulatory & Clinical Manager Paltop Advanced Dental Solutions Ltd. 5 Hashita Street Caesarea ISRAEL 30889

Re: K112795

Dear Ms. Hammer-Topaz:

APR 2 0 2012

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Page 2 – Ms. Hammer-Topaz

Sincerely yours,

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, 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): K12795

Device Name: PALTOP Advanced Dental Solutions System

Indications for Use:

Prescription Use > AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)

	Concurrence of CDRH, Office of Device Evaluation (ODE)

	(Division Sign-Off)
	Division of Anesthesiology, General HospitalInfection Control, Dental Devices
510(k) Premarket Notification	510(k) Number:/ 12112795 page.4-2

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.