The Paltop Narrow Implant is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by the adjacent teeth and roots, to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Paltop Narrow Implant is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Device Description

Paltop Narrow Implants, as other implants available in the market, are essentially a substitute for a natural tooth. Paltop Narrow Implants, as other implants available in the market, are one and two stage endosseous screw type implant with internal hexagonal connection, intended for single use. As other implants available in the market, they are fabricated from titanium alloy, Titanium -6 Aluminum 4 Vanadium ELI alloy, according to ASTM F136-98, a biologically compatible material to vital tissue, and surface treated with sand blasting and acid etching. The Paltop Narrow Implant is a suitable treatment option when the possibility of placing a standard implants is limited due to physical conditions, where the horizontal space is limited by adjacent teeth and roots, or in situations with a narrow alveolar ridge. By using a narrow implant the need for bone augmentation or orthodontic tooth movement can be avoided. The Paltop narrow implants are 3.25mm-wide and are available in lengths of 10mm, 11.5mm, 13mm and 16mm.

AI/ML Overview

Below is an analysis of the provided text regarding the Paltop Narrow Implant's acceptance criteria and studies.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than providing specific performance metrics against defined acceptance criteria. Therefore, explicit numerical acceptance criteria and corresponding device performance values are not directly stated in the document.

Instead, the acceptance for this device is based on demonstrating comparability with predicate devices in terms of:

Acceptance Criteria Category	Reported Device Performance (as stated in the document)
Intended Use	Same as predicate devices (Paltop Dental Implant System, MIS UNO Narrow, Astra Tech OsseoSpeed Narrow).
Technological Characteristics	Similar to predicate devices (same operating principle, basic design, materials, packaging, sterilization procedures). Specific comparisons are detailed in the "Technological Characteristics – comparative table – Narrow Implants" for: - Product Code - Manufacturer - Intended Use/Indications for Use - Components - Supplied Sterile - Re-Use - Material Composition - Surface Treatment - Shape - Length - Diameters - Abutments - Material Composition of Abutments - Surface Treatment of Abutments
Safety and Effectiveness	"Fatigue testing of the modified device showed that implants are safe and effective and meets existing acceptance criteria." "Other performance testing and validations (corrosion resistance, surface analysis, biocompatibility evaluation, sterilization and shelf life validation) previously conducted to the standard device were shown to be applicable to the modified design, as their results may not be affected by the dimensional changes." "Bench testing and validations demonstrates that the narrow implants are substantially equivalent to predicate devices and do not raise new issues of safety or effectiveness."

2. Sample Size for the Test Set and Data Provenance

The document explicitly states "Clinical Tests: Not applicable." This indicates that no human test set was used for this 510(k) submission. The evaluation was based on non-clinical (bench) testing and comparison to predicate devices. The data provenance is therefore from bench testing conducted by Paltop Advanced Dental Solutions Ltd. specific to the modified device design and existing data for the standard device. The country of origin of the device manufacturer is Israel.

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

Since no clinical test set was used, there was no ground truth established by experts for a clinical study. The "ground truth" for demonstrating substantial equivalence was established through analytical and bench testing data compared against the characteristics of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

Not applicable. The document explicitly states "Clinical Tests: Not applicable," and therefore no MRMC study was conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical dental implant, not a software algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant.

7. Type of Ground Truth Used

For the purpose of this 510(k) submission, the "ground truth" was established through:

Bench Test Results: Demonstrating material properties, mechanical strength (fatigue), corrosion resistance, surface analysis, biocompatibility, sterilization, and shelf-life meet acceptable standards and are comparable to predicate devices.
Comparison to Predicate Device Specifications: The detailed comparative table and narrative establish equivalence based on the known and accepted characteristics of the legally marketed predicate devices.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning algorithm, therefore there is no concept of a "training set" in the context of this submission. The "training" for the device's design and manufacturing would involve engineering principles and design verification and validation, not data-driven algorithm training.

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

Not applicable, as there is no "training set" for a physical dental implant. The development and validation process would involve design inputs, design verification, and design validation activities, often referencing international standards and established scientific principles for medical device safety and performance.

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 graphic on the left, followed by the word "PALTOP" in a bold, modern font. Below the company name and logo is the tagline "With you to the TOP" in a cursive font.

510(k) SUMMARY

510(k) Number K | 3046 2

Applicants Name: Paltop Advanced Dental Solutions Ltd. Hashita 5 Industrial Park Caesarea 30889, Israel T +972 4 6271711 F +972 4 6275363

Contact Person: Tal Hammer-Topaz 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

AUG 27 2013

February 18th, 2013 Date Prepared:
Trade Name: Paltop Narrow Implant

Classification Name: Implant, Endosseous, Root-form

Common usual name: Dental Implant

Medical Specialty: Dental

Product Code: DZE, NHA

Device Class: Class II
Regulation Number: 872.3640
Review Panel: Dental Device Panel

Predicate Devices:

Paltop Narrow Implant is relying on the combination of the following predicate devices:

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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 inside a circle on the left, followed by the word "PALTOP" in a bold, sans-serif font. A small circle with a degree symbol is located to the right of the "P". The text "With you to the TOP" is written in a cursive font below the logo.

Paltop Dental Implant System (Paltop Advanced Dental Solutions Ltd.) cleared . under K112795; product code DZE, NHA (Implant, Endosseous, Root-Form).
UNO Narrow Implant (MIS Implant Technologies Ltd.) cleared under K092555; . product code DZE, NHA (Implant, Endosseous, Root-Form).
Osseospeed " Narrow (ASTRA Tech AB) cleared under K080396; product code . DZE,NHA (Implant, Endosseous, Root-Form)

Intended Use / Indication for Use:

Device Description:

The Paltop Narrow Implant is a suitable treatment option when the possibility of placing a standard implants is limited due to physical conditions, where the horizontal space is

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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 graphic on the left, followed by the word "PALTOP" in a modern, sans-serif font. Below the company name is the tagline "With you to the TOP" in a cursive font.

limited by adjacent teeth and roots, or in situations with a narrow alveolar ridge. By using a narrow implant the need for bone augmentation or orthodontic tooth movement can be avoided.

The Paltop narrow implants are 3.25mm-wide and are available in lengths of 10mm, 11.5mm, 13mm and 16mm.

Substantial Equivalence:

The proposed Paltop Narrow Implants have similar indications for use, technological characteristics, mode of operation and performance specification as the predicates MIS Implants and Astra-Tech Implants. The proposed devices have the same intended use as the predicates and are 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.

	PALTOP Narrow	PALTOP Dental	MIS UNO Narrow	Astra Tech
	lmplants	Implant System	lmplant	OsseoSpeed Narrow
K#		Cleared under	Cleared under	Cleared under
		K#112795	KHO92555	K#080396
Product Code	DZE, NHA	DZE, NHA	DZE, NHA	DZE, NHA
Manufacturer	Paltop Advanced	Paltop Advanced	MIS Implant	Astra Tech AB
	Dental Solutions Ltd.	Dental Solutions Ltd.	Technologies Ltd.
Intended Use/	The Narrow Implant is	The Paltop Dental	The UNO Narrow	The OsseoSpeed
Indications for	indicated for use in	lmplant System is	implant is indicated	Narrow is intended to
Use	surgical and	indicated for use in	for use in surgical and	be used to replace
	restorative	surgical and	restorative	missing masticatory
	applications for	restorative	applications for	functional units
	placement in the	applications for	placement in the	(teeth) in single or
	mandibular central,	placement in the	mandibular central,	multiple unit
	lateral incisor and	bone of the upper or	lateral incisor and	applications within
	maxillary lateral	lower jaw to provide	maxillary lateral	the mandible or
	incisor regions of	support for prosthetic	incisor regions of	maxilla. The device
	partially edentulous	devices, such as	partially edentulous	may be equally well in
	jaws where the	artificial teeth, in	jaws where the	single-stage or two-
	horizontal space is	order to restore the	horizontal space is	stage surgical
	limited by the	patient's chewing	limited by the	procedure. It is
	adjacent teeth and	function. The Paltop	adjacent teeth and	indicated for
	PALTOP Narrow	PALTOP Dental	MIS UNO Narrow	Astra Tech
	Implants	Implant System	Implant	OsseoSpeed Narrow
	roots, to provide	Dental ImplantSystem is indicatedalso for immediateloading when goodprimary stability isachieved and withappropriate occlusalloading.	roots,jaw to providesupport for prostheticdevices, such asartificial teeth, inorder to restore thepatient's chewingfunction. Mandibularcentral and lateralincisors must besplinted if using twoor more φ3.0mmimplnats adjacent toone another. . TheUNO Narrow Implantis indicated forimmediateimplantation in theextraction sites orimplantation inpartially healed orcompletely healedalveolar ridgesituations.When a one stagesurgical procedure isapplied, the implantmay be immediatelyloaded when goodprimary stability isachived and theocclusal load isappropriate.	immediateimplantation inextraction sites orimplantation inpartially healedalveolar ridgesituations. When aone-stage surgicalapproach is applied,the implant may beimmediattely loadedwhen good primarystability is achivedand functional load isappropriate. TheOsseoSpeed Narrowproduct line shall beused only to replacemaxillary lateralincisors andmandibular lateraland central incisors.The fluoride-modifiedsurface, thoughhaving a fluoride ionlevel far below theneeded for cariesprevention in theeth,provides a favorablesubstrate for boneattachment andosseointegration.OsseoSpeed Narrowis especially indicatedfor use in soft boneapplications whereimplants with otherimplant surfacetreatment may beless effective.Becauseinitial stability may bedifficult to obtain inType IV bone,immediate loading ofsungle toothrestorations may notbe appropriate insuch situations.
Components	Dental implants,cover screws healingcaps; abutmentsystems andsuperstructures;	Dental implants,cover screws healingcaps; abutmentsystems andsuperstructures;surgical instruments.	Dental implants,cover screws healingcaps; abutmentsystems andsuperstructures;	Dental implants,cover screws healingcaps; abutmentsystems andsuperstructures;
Clinical Data	Not applicable	Not applicable	Not applicable	Not applicable
	PALTOP NarrowImplants	PALTOP DentalImplant System	MIS UNO NarrowImplant	Astra TechOsseoSpeed Narrow
SuppliedSterile	Yes	Yes	Yes	Yes
Re-Use	No	No	No	No
MaterialComposition	Titanium alloy	Titanium alloy	Titanium alloy	Titanium alloy
Surfacetreatment	Sand Blasting andAcid Etching	Sand Blasting andAcid Etching	Sand Blasting andAcid Etching	Fluride-modifiedsurface
Shape	Screw type	Screw type	Screw type	Screw type
Length	10mm, 11.5mm,13mm, 16mm	8mm, 10mm,11.5mm, 13mm,16mm	10mm, 11.5mm,13mm, 16mm	11mm, 13mm, 15mm
Diameters	3.25mm	3.75mm, 4.2mm,5.0mm	3.0mm	3.0mm
Abutments	Straight and up to 20°	Straight and up to 25°	Straight and up to 20°	Straight and up to 20°
MaterialComposition ofAbutments	Titanium alloy,	Titanium alloy, Plastic(PEEK)	Titanium alloy, Plastic	Titanium alloy
SurfaceTreatment ofAbutments	None	None	None	None

Technological Characteristics – comparative table – Narrow Implants

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With you to the TOP

ー

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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 a circle on the left. To the right of the tooth is the word "PALTOP" in a stylized font.

With you to the TOP

The Paltop Narrow Implants have the following similarities to their predicate devices:

Have the same intended use .
Use the same operating principle .
. Incorporate the same basic design
. Incorporate the same materials
. Have similar packaging
Sterilized using the same procedures .

Non Clinical Tests:

Risk analysis process was conducted to assess the impact of the modification of the device. Bench testing, verification and validation activities previously conducted to the standard device were re-evaluated for their applicability to the modified device. Fatigue testing of the modified device showed that implants are safe and effective and meets existing acceptance criteria. Other performance testing and validations (corrosion resistance, surface analysis, biocompatibility evaluation, sterilization and shelf life validation) previously conducted to the standard device were shown to be applicable to the modified design, as their results may not be affected by the dimensional changes.

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Image /page/5/Picture/0 description: The image shows the logo for Advanced Dental Solutions Ltd. The logo includes a stylized tooth inside of a circle on the left. To the right of the tooth is the company name, "PALTOP" in large, bold letters. Below the company name is the slogan "With you to the TOP".

Bench testing and validations demonstrates that the narrow implants are substantially equivalent to predicate devices and do not raise new issues of safety or effectiveness.

Clinical Tests:

Not applicable

Summary:

The evaluation of Paltop Narrow Implants do not raise any additional concerns regarding safety and effectiveness of the device and therefore Paltop Advanced Dental Solutions Ltd. believes that Paltop Narrow Implants may be considered as substantially equivalent to their predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

August 27, 2013

Paltop Advanced Dental Solutions Limited C/O Mr. Tal Hammer-Topaz Quality, Regulatory & Clinical Manager Hashita 5, PO Box 3568 Caesarea 30889 ISRAEL

Re: K130462

Trade/Device Name: Paltop Narrow Implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: July 25, 2013 Received: July 31, 2013

Dear Mr. 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.

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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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/7/Picture/5 description: The image shows the name "Mary S. Runner -S" in a bold, sans-serif font. The text is horizontally oriented and appears to be a title or heading. The letters are uniformly sized and spaced, creating a clean and legible presentation.

Kwame Ulmer M.S. Acting Division 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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Image /page/8/Picture/0 description: The image shows the logo for Advanced Dental Solutions Ltd. The logo includes a stylized image of a tooth inside of a circle. Next to the circle is the word "PALTOP" in a bold, sans-serif font. Below the logo is the phrase "With you to the TOP" in a cursive font, and below that is the phrase "Indications for Use" in a bold, sans-serif font.

510(k) Number: K130462

Device Name:

PALTOP Narrow Implant

AND/OR Over-The-Counter Use __________________________________________________________________________________________________________________________________________________ Prescription 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)

Sheena A. Green -S 2013.08.27 16:47:17 -04'00

(Division Sign-Off) Division of Anesthesiology, General Hospital Respiratory, Infection Control and Dental Devices 510(k) Number:

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.