Predicate Devices

Reference Devices

K103089, K092035, K210117, K220200, K112795

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a physical dental implant system and does not mention any software, algorithms, or AI/ML capabilities.

Therapeutic

Yes

These implants are used to restore chewing function by providing artificial tooth support, addressing a physiological dysfunction.

Diagnostic

No

Explanation: The device is an artificial root structure (dental implant) used to restore chewing function. Its purpose is structural and functional support, not diagnosis. The text describes its use in surgical and restorative applications, and various testings performed, none of which relate to diagnosing a condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly states it comprises physical components like endosseous root-form dental implants, cover screws, and compatible abutments, which are surgically implanted. It also details the materials used (Titanium alloy) and manufacturing processes.

IVD (In Vitro Diagnostic)

Based on the provided text, the Paltop Short Implants are not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use clearly states that the device is for surgical and restorative applications, acting as an artificial root structure in the bone to support prosthetic devices and restore chewing function. This is a direct intervention on the patient's body.
Device Description: The description details a physical implant and associated components that are surgically placed in the jawbone.
Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a physiological state, health, disease, or congenital abnormality.
- Being used in a laboratory setting for diagnostic purposes.

The Paltop Short Implants are a medical device used for surgical and prosthetic purposes, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Paltop Short Implants (Internal Hex and Conical Connections) are in surgical and restorative applications for placement in the bone of the upper or lower jaw as an artificial root structure for single tooth replacement or for fixed bridgework to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Paltop Short Implants are indicated to be used only with straight abutments and are for delayed loading only.

Product codes (comma separated list FDA assigned to the subject device)

DZE, NHA

Device Description

The purpose of this submission is for the marketing clearance for the Paltop Short Implants which comprises endosseous root-form dental implants, cover screw, and compatible abutments.

The Subject device abutments are compatible with prior cleared implant bodies, and abutments from prior clearances are compatible with new Subject device implant bodies. Subject device abutments are also compatible with previously cleared implant bodies in K112795. Subject device are compatible with straight abutments previously cleared in K112795, K131451, K220200, and K221381.

Endosseous dental implants are surgically implanted into a patient's mouth to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Endosseous dental implant abutments are secured to dental implants with a retaining screw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.

The Paltop Short Implant System includes endosseous screw type dental implant bodies, which can be used in twostage surgeries with associated compatible abutments. The Subject device abutments provide a range of cementretained and screw-retained prosthetic solutions for dental implant restoration. Paltop Short Implant System includes six compatible implant abutment designs: Healing Caps, Straight, Temporary, Snap-On Abutment System (SAS) Abutment, and Straight Ball Abutment.

The implant bodies, titanium abutments and cover screw are fabricated from a Titanium 4 Vanadium ELI titanium alloy (Grade 23) which conforms to ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium EU (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The Subject device implant bodies are surface treated with SLA (Sand-blasted, Large Grit, Acid Etched). The Snap On Abutment System(SAS) Abutments are supplied sterile with a PEEK cap.

All implants and prosthetic components are one-time use device components are provided sterile and sterilized by gamma irradiation except for the replacement cover screws which are provided nonsterile. Devices provided as non-sterile are sterilized by steam.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

bone of the upper or lower jaw

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Comparative testing in the form of Pull-Out, surface area and BIC testing was performed to ensure that the performance of the subject device is appropriate for its intended use.

According to 'Root-form Endosseous Dental Implants and Endosseous Dental Abutments - Class II Special Controls Guidance Document for Industry and FDA Staff', static and dynamic testing were not required to be performed for the purposes of this submission. As stated in the FDA guidance document, it is recommended to conduct fatigue testing on devices which : 'consist of angled abutments; are implant or abutment designs that are significantly different from predicate devices; or have design features or technological characteristics that have not been previously cleared for market'. Since none of these criteria are applicable for the Paltop Short Implants, it was concluded that fatigue testing is not required.

Biological Evaluation of the Subject device was performed according to ISO 10993-1.

Endotoxin testing on the Subject device or suitable test specimens are performed following USP and USP according to the sponsor's endotoxin sampling plan, and testing is leverage from the sponsor's Reference device K210117.

Test results and Sterilization revalidations performed for the sponsor's Reference devices K210117 and Subject Devices are leveraged to demonstrate suitable sterilization of the Subject device sterile components.

Shelf-life testing is leveraged from the sponsor's Reference device K210117 to support shelf-life of Subject device sterile components.

Cleaning and sterilization validations for non-sterile components which may be modified and require subsequent sterilization is leveraged from the Reference device K210117.

Non-clinical worst-case MRI review was performed to evaluate the Subject device components in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, and fixation screws) and material composition. The Subject devices are composed of material that is electrically nonconductive, nonmetallic, and nonmagnetic. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.

No clinical data were included in this submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K172576

Reference Device(s)

K103089, K092035, K210117, K220200, K112795

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

Paltop Advanced Dental Solutions, Ltd Zina Gurgov VP of QA/RA Hashita 5, Industrial Park P.O. Box 3568 Caesarea, 3088900 ISRAEL

May 22, 2024

Re: K232740

Trade/Device Name: Paltop Short Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: April 21, 2024 Received: April 22, 2024

Dear Zina Gurgov:

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 (the 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 available 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

2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

2

3

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K232740

Device Name Paltop Short Implants

Indications for Use (Describe)

Paltop Short Implants (Internal Hex and Conical Connections) are in surgical and restorative applications for placement in the bone of the upper or lower jaw as an artificial root structure for single tooth replacement or for fixed bridgework to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Paltop Short Implants are indicated to be used only with straight abutments and are for delayed loading only.

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)

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4

510(k) Summary K232740 Paltop Advanced Dental Solutions, Ltd. Paltop Short Implants

ADMINISTRATIVE INFORMATION

| Manufacturer Name | Paltop Advanced Dental Solutions, Ltd
Hashita 5, Industrial Park
Caesarea 3088900
Israel
Telephone: +(972) 4-627-1711
Email: zgurgov@keystonedental.com |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Zina Gurgov |
| Date Submitted | May 22, 2024 |

DEVICE NAME AND CLASSIFICATION

Trade/Device Name	Paltop Short Implants
Common Name	Implant, Endosseous, Root-Form
Classification Name	Endosseous dental implant
Regulation Number	21 CFR 872.3640
Regulation Name	Endosseous dental implant
Regulatory Class	Class II
Product Code	DZE, NHA
Classification Panel	Dental Products Panel
Reviewing Office	Office of Health Technology 1 (OHT1: Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices)
Reviewing Division	Division of Health Technology 1 B (Dental and ENT Devices)

PREDICATE DEVICE INFORMATION

The Subject device is substantially equivalent in Indications for Use, and technological/design principles to the following legally marketed primary predicate device:

510(k)	Primary Predicate Device Name	Company Name
K172576	BioHorizons Tapered Short Implants	BioHorizons Implant System, Inc.

Reference devices were leveraged for technology, material, implant connections, sterility, and design principles.

5

510(k)	Reference Predicate Device Name	Company Name
K103089	MIS Short Implants	MIS Implants Technologies Ltd.
K092035	Bicon Implants with a 2.5mm Internal Connection	Bicon, LLC
K210117	Paltop Narrow Implant	Paltop Advanced Dental Solutions Ltd.
K220200	Paltop Conical Implant System	Paltop Advanced Dental Solutions Ltd.
K112795	Paltop Dental Implant System	Paltop Advanced Dental Solutions Ltd.

DEVICE DESCRIPTION

The purpose of this submission is for the marketing clearance for the Paltop Short Implants which comprises endosseous root-form dental implants, cover screw, and compatible abutments.

The Subject device abutments are compatible with prior cleared implant bodies, and abutments from prior clearances are compatible with new Subject device implant bodies. Subject device abutments are also compatible with previously cleared implant bodies in K112795. Subject device are compatible with straight abutments previously cleared in K112795, K131451, K220200, and K221381.

Endosseous dental implants are surgically implanted into a patient's mouth to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Endosseous dental implant abutments are secured to dental implants with a retaining screw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.

The Paltop Short Implant System includes endosseous screw type dental implant bodies, which can be used in twostage surgeries with associated compatible abutments. The Subject device abutments provide a range of cementretained and screw-retained prosthetic solutions for dental implant restoration. Paltop Short Implant System includes six compatible implant abutment designs: Healing Caps, Straight, Temporary, Snap-On Abutment System (SAS) Abutment, and Straight Ball Abutment.

The implant bodies, titanium abutments and cover screw are fabricated from a Titanium 4 Vanadium ELI titanium alloy (Grade 23) which conforms to ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium EU (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The Subject device implant bodies are surface treated with SLA (Sand-blasted, Large Grit, Acid Etched). The Snap On Abutment System(SAS) Abutments are supplied sterile with a PEEK cap.

All implants and prosthetic components are one-time use device components are provided sterile and sterilized by gamma irradiation except for the replacement cover screws which are provided nonsterile. Devices provided as non-sterile are sterilized by steam.

6

Paltop Short Implants - Implant Sizes
Implant Type	Prosthetic Interface Connection	Implant Diameters (mm)	Implant Platform Diameter (mm)	Lengths (mm)
Advanced	Internal Hex	Ø 4.2	Ø 3.65	6
		Ø 5.0	Ø 3.65	6
		Ø 6.0	Ø 4.4	6
Advanced +	Internal Hex	Ø 4.2	Ø 3.65	6
		Ø 5.0	Ø 3.65	6
		Ø 6.0	Ø 4.4	6
Dynamic	Internal Hex	Ø 4.2	Ø 3.65	6
		Ø 5.0	Ø 3.65	6
		Ø 6.0	Ø 4.4	6
Dynamic Conical	Conical Connection	Ø 4.2	Ø 2.9	6
		Ø 5.0	Ø 2.9	6
Dynamic Conical MC	Conical Connection	Ø 4.2	Ø 2.9	6
		Ø 5.0	Ø 2.9	6
PCA	Conical Connection	Ø 4.2	Ø 2.9	6
		Ø 5.0	Ø 2.9	6
PAI	Internal Hex	Ø 4.2	Ø 3.65	6
		Ø 5.0	Ø 3.65	6
		Ø 6.0	Ø 4.4	6
PAI TC	Internal Hex	Ø 4.2	Ø 3.65	6
		Ø 5.0	Ø 3.65	6
		Ø 6.0	Ø 4.4	6

Paltop Short Implants – Abutment Types

		Subject Device Abutment Designs
Connection Platform	Implant Diameter (mm)	Healing Caps
Image: Healing Caps	Straight
Image: Straight	Temporary
Image: Temporary	SAS
Image: SAS	Straight Ball
Image: Straight Ball
Internal Hex SP	4.2	X	Not included	X	X	X
Internal Hex SP	5.0	X	Not included	X	X	X
Internal Hex WP	6.0	X	X	X	X	Not included
	Indexed/Non-Indexed	Non-
indexed	Indexed	Indexed,
Non-Indexed	Indexed	Non-
indexed
Material		Ti-6Al-4V ELI	Ti-6Al-4V ELI	Ti-6Al-4V ELI	Ti-6Al-4V ELI	Ti-6Al-4V ELI
Finish		WP- Purple
Anodize
SP- None	None	None	None	None

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INDICATIONS FOR USE

Paltop Short Implants (Internal Hex and Connections) are indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw as an artificial root structure for single tooth replacement or for fixed bridgework to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Paltop Short Implants are indicated to be used only with straight abutments and are for delayed loading only.

EQUIVALENCE TO MARKETED DEVICE

The Subject device is highly similar to the Predicate device with respect to Indications for Use and technological principles. The Comparison tables below compare the Indications for Use and Technological Characteristics of the Subject and Predicate/Reference devices.

	Indications for Use Comparison Table
Device	Indications for Use Statement
Subject Device	Paltop Short Implants (Internal Hex and Conical Connections) are indicated for use in surgical and
Paltop Short Implants	restorative applications for placement in the bone of the upper or lower jaw as an artificial root structure
	for single tooth replacement or for fixed bridgework to provide support for prosthetic devices, such as
Paltop Advanced	artificial teeth, in order to restore the patient's chewing function. Paltop Short Implants are indicated to
Dental Solutions Ltd.	be used only with straight abutments and are for delayed loading only.
	BioHorizons Tapered Short Implants are intended for use in the mandible or maxilla as an artificial root
Primary Predicate Device	structure for single tooth replacement or for fixed bridgework and dental retention. The implants may be
BioHorizons Tapered Short	restored using delayed loading, or with a terminal or intermediate abutment for fixed or removable
Implants	bridgework, and for overdentures.
(K172576)

BioHorizons Implant System, Inc
Reference Device	MIS dental implants are intended to be surgically placed in the bone of the upper or lower jaw arches to
MIS Short Implants	provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing
(K103089)	function.

MIS Implants Technologies Ltd.	When a one stage surgical procedure is applied, the implant may be immediately loaded when good
	primary stability is achieved and the occlusal load is appropriate.

	MIS short implants are to be used only with straight abutments.
Reference Device	The Bicon implant is designed for use in edentulous sites in the mandible or maxilla for support of a
Bicon Implants with a 2.5mm	complete denture prosthesis, a final or intermediate abutment for fixed bridgework or for partial
Internal Connection	dentures, or as a single tooth replacement.
(K092035)

Bicon, LLC
Reference Device	The Paltop Conical Implant System is indicated for use in surgical and restorative applications for
Paltop Conical Implant System	placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as
(K220200)	artificial teeth, in order to restore the patient's chewing function. Narrow diameter implants are intended
	for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially
Paltop Advanced	edentulous jaws where the horizontal space is limited by the adjacent teeth and roots. The Paltop Conical
Dental Solutions Ltd.	Implant System is also indicated for immediate loading when good primary stability is achieved and with
	appropriate occlusal loading.
Reference Device	The Paltop Narrow Implant is indicated for use in surgical and restorative applications for placement in
Paltop Narrow Implant	the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws
(K210117)	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
Paltop Advanced	Implant is indicated also for immediate loading when good primary stability is achieved and with
Dental Solutions Ltd.	appropriate occlusal loading.

Comparison of Indications for Use Statements

8

Indications for Use Comparison Table
Device	Indications for Use Statement
Reference Device
Paltop Advanced Dental
Solutions System
(K112795)

Paltop Advanced
Dental Solutions Ltd. | 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. |

The Subject and primary Predicate devices have highly similar Indications for Use, differing primarily in device name and grammar. The primary Predicate device is indicated for use as an 'artificial root structure for single tooth replacement or for fixed bridgework and dental retention', while the Subject device does not indicate for 'dental retention'. The primary Predicate device is indicated for use for to be 'restored using , or with a terminal or intermediate abutment for fixed or removable bridgework, and for overdentures', whereas the Subject device is indicated for 'delayed loading'. The indications are expressed highly similarly using different wording, such as the addition of 'to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function' in the Subject device's IFUS. The Indications for Use of the Subject device indicates that the Paltop Short Implants are only to be used with straight abutments, which is more limited than the primary predicate device.

9

Paltop Short Implants

Comparison of Technological Characteristics
Design Parameter	Subject Device
Paltop Short
Implants
Paltop Advanced
Dental Solutions
Ltd.	Primary Predicate
Device
BioHorizons
Tapered Short
Implants
(K172576)
BioHorizons
Implant System,
Inc.	Reference Device
MIS Short
Implants
(K103089)
MIS Implants
Technologies Ltd.	Reference Device
Bicon Implants with
a 2.5mm Internal
Connection
(K092035)
Bicon, L.L.C.	Reference Device
Paltop Conical
Implant System
(K220200)
Paltop Advanced
Dental Solutions Ltd.	Reference Device
Paltop Narrow Implant
(K210117)
Paltop Advanced
Dental Solutions Ltd.	Reference Device
Paltop Advanced
Dental Solutions
System
(K112795)
Paltop Advanced
Dental Solutions Ltd.
Regulation #	21 CFR 872.3640	21 CFR 872.3640	21 CFR 872.3640	21 CFR 872.3640	21 CFR 872.3640	21 CFR 872.3640	21 CFR 872.3640
Product Code	DZE, NHA	DZE	DZE	DZE, NHA	DZE, NHA	DZE, NHA	DZE, NHA
Classification	Class II	Class II	Class II	Class II	Class II	Class II	Class II
Materials	Implants/Screws -
Titanium Ti-6Al-
4V ELI
Abutments-
Titanium Ti-6Al-
4V ELI, PEEK	Titanium Ti-6Al-
4V	Titanium Ti-6Al-
4V ELI	Titanium Ti-6Al-4V	Implants/Screws -
Titanium Ti-6Al-4V ELI
Abutments- Titanium
Ti-6Al-4V ELI, PEEK	Implants/Screws -
Titanium Ti-6Al-4V ELI
Abutments- Titanium
Ti-6Al-4V ELI	Implants/Screws -
Titanium Ti-6Al-4V ELI
Abutments- Titanium
Ti-6Al-4V ELI
Reason for
Predicate/
Reference	Not Applicable	• Indications for
Use
• Implant
diameters
• Implant length
• Material	• Implant
diameters
• Implant length
• Machined neck	• Implant diameters
• Implant length
• Material
• Implant neck
design - non-
threaded surface
neck	• Implant Design
• Implant/ Abutment
Interface
• Abutment Design
• Implant Modified
Surface
• Material
• Biocompatibility
• Sterilization
• Labeling	• Implant Design
• Implant/ Abutment
Interface
• Abutment Design
• Implant Modified
Surface
• Material
• Biocompatibility
• Sterilization
• Labeling	• Implant Design
• Implant/Abutment
Interface
• Abutment Design

Comparison of Technological Characteristics

10

Implant Design
	Technological Characteristics Comparison Table – Implant Design
Design
Parameter	Subject Device
Paltop Short
Implants

Paltop Advanced
Dental Solutions
Ltd. | Primary Predicate
Device
BioHorizons
Tapered Short
Implants
(K172576)

BioHorizons
Implant System,
Inc. | Reference Device
MIS Short Implants
(K103089)

MIS Implants
Technologies Ltd. | Reference Device
Bicon Implants with a
2.5mm Internal
Connection
(K092035)

BICON, LLC | Reference Device
Paltop Conical Implant System
(K220200)

Paltop Advanced
Dental Solutions Ltd. | Reference Device
Paltop Narrow Implant
(K210117)

Paltop Advanced
Dental Solutions Ltd. | Reference Device
Paltop Advanced Dental
Solutions System
(K112795)

Paltop Advanced
Dental Solutions Ltd. |
| Implant
Descriptio
n | Advanced the following: Here is the JSON requested: ```json { | | | | | | |
| Design
Parameter | Subject Device
Paltop Short
Implants
Paltop Advanced
Dental Solutions
Ltd. | Primary Predicate
Device
BioHorizons
Tapered Short
Implants
(K172576)
BioHorizons
Implant System,
Inc. | Reference Device
MIS Short Implants
(K103089)
MIS Implants
Technologies Ltd. | Reference Device
Bicon Implants with a
2.5mm Internal
Connection
(K092035)
BICON, LLC | Reference Device
Paltop Conical Implant System
(K220200)
Paltop Advanced
Dental Solutions Ltd. | Reference Device
Paltop Narrow Implant
(K210117)
Paltop Advanced
Dental Solutions Ltd. | Reference Device
Paltop Advanced Dental
Solutions System
(K112795)
Paltop Advanced
Dental Solutions Ltd. |
| | connection.
Parallel coronal
and midsection,
micro threads on
neck, reverse
buttress thread in
mid-section
tapering to an
active/cutting
apex. Platform
switching taper on
implant top level.
Dynamic Conical-
Endosseous screw-
type implant with
internal
connection.
Parallel coronal
and midsection,
micro threads on
neck, reverse
buttress thread in
mid-section
tapering to an
active/cutting
apex. Platform
switching taper on
implant top level.
Dynamic Conical
MC- Endosseous
screw-type implant
with internal
connection.
Parallel coronal
and midsection,
0.8mm machined | | | | | | |
| Technological Characteristics Comparison Table - Implant Design | | | | | | | |
| Design
Parameter | Subject Device
Paltop Short
Implants

Paltop Advanced
Dental Solutions
Ltd. | Primary Predicate
Device
BioHorizons
Tapered Short
Implants
(K172576)

BioHorizons
Implant System,
Inc. | Reference Device
MIS Short Implants
(K103089)

MIS Implants
Technologies Ltd. | Reference Device
Bicon Implants with a
2.5mm Internal
Connection
(K092035)

BICON, LLC | Reference Device
Paltop Conical Implant System
(K220200)

Paltop Advanced
Dental Solutions Ltd. | Reference Device
Paltop Narrow Implant
(K210117)

Paltop Advanced
Dental Solutions Ltd. | Reference Device
Paltop Advanced Dental
Solutions System
(K112795)

Paltop Advanced
Dental Solutions Ltd. |
| | buttress thread in
mid-section
tapering to an
active/cutting
apex. Platform
switching taper on
implant top level.

PCA- Endosseous
screw-type implant
with internal
connection.
Parallel coronal
and midsection,
micro threads on
neck, double
leaded "V" shape
progressive thread,
tapered apically,
active apex.
Platform switching
taper on implant
top level. | | | | | | |
| | PAI - Endosseous
screw-type implant
with internal hex
connection.
Machined neck.
Parallel midsection
with double lead
thread, tapered
apically with active
apex. Platform
switching taper on
implant top level. | | | | | | |
| | PAI TC -
Endosseous screw- | | | | | | |

11

_Traditional 510(k) Submission

12

_Traditional 510(k) Submission

13

Traditional 510(k) Submission


Design
Parameter	Subject Device
Paltop Short
Implants
Paltop Advanced
Dental Solutions
Ltd.	Primary Predicate
Device
BioHorizons
Tapered Short
Implants
(K172576)
BioHorizons
Implant System,
Inc.	Reference Device
MIS Short Implants
(K103089)
MIS Implants
Technologies Ltd.	Reference Device
Bicon Implants with a
2.5mm Internal
Connection
(K092035)
BICON, LLC	Reference Device
Paltop Conical Implant System
(K220200)
Paltop Advanced
Dental Solutions Ltd.	Reference Device
Paltop Narrow Implant
(K210117)
Paltop Advanced
Dental Solutions Ltd.	Reference Device
Paltop Advanced Dental
Solutions System
(K112795)
Paltop Advanced
Dental Solutions Ltd.
	type implant with
internal hex
connection.
Machined Neck.
Implant surface
treatment
extending to the
implant top level.
Parallel midsection
with double lead
thread, tapered
apically with active
apex. Platform
switching taper on
implant top level.
Implant
Dimensions
D = Implant
Body
Diameter
(mm)
IP = Implant
Platform
Diameter
(mm)
L = Implant
Length
(mm)
NP = Not
provided	D
IP
L
4.2
3.65
6.0
5.0
3.65
6.0
6.0
4.4
6.0	D
IP
L
4.6
NP
6.0,
7.5
5.8
NP
6.0,
7.5	D
IP
L
4.2
NP
6.0
5.0
NP
6.0
6.0
NP
6.0	D
IP
L
4.0
2.5
5.0
4.0
2.5
6.0
4.0
2.5
8.0
4.0
2.5
11.0	D
IP
L
3.25
2.9
10, 11.5, 13,
16
3.75
2.9
8, 10, 11.5,
13, 16
4.2
2.9
8, 10, 11.5,
13, 16
5.0
2.9
8, 10, 11.5,
13, 16	D
IP
L
3.0
2.9
10, 11.5,
13, 16	D
IP
L
3.75
3.65
8, 10,
11.5,
13, 16
4.2
3.65
8, 10,
11.5,
13, 16
5.0
3.65
8, 10,
11.5,
13, 16
Mode of
Operation	Provide support for
prosthetic devices,
such as artificial
teeth, in order to
restore the
patient's chewing
function.	An artificial root
structure for single
tooth replacement
or for fixed
bridgework and
dental retention.
The implants may
be restored using
delayed loading, or
with a terminal or	Not provided	The Bicon implant is
designed for use in
edentulous sites in the
mandible or maxilla for
support of a complete
denture prosthesis, a
final or intermediate
abutment for fixed
bridgework or for partial	Provide support for prosthetic
devices, such as artificial teeth,
in order to restore the patient's
chewing function.	Provide support for
prosthetic devices, such as
artificial teeth, in order to
restore the patient's
chewing function.	Provide support for
prosthetic devices, such
as artificial teeth, in
order to restore the
patient's chewing
function.

14

Traditional 510(k) Submission

	Technological Characteristics Comparison Table - Implant Design
Design
Parameter	Subject Device
Paltop Short
Implants
Paltop Advanced
Dental Solutions
Ltd.	Primary Predicate
Device
BioHorizons
Tapered Short
Implants
(K172576)
BioHorizons
Implant System,
Inc.	Reference Device
MIS Short Implants
(K103089)
MIS Implants
Technologies Ltd.	Reference Device
Bicon Implants with a
2.5mm Internal
Connection
(K092035)
BICON, LLC	Reference Device
Paltop Conical Implant System
(K220200)
Paltop Advanced
Dental Solutions Ltd.	Reference Device
Paltop Narrow Implant
(K210117)
Paltop Advanced
Dental Solutions Ltd.	Reference Device
Paltop Advanced Dental
Solutions System
(K112795)
Paltop Advanced
Dental Solutions Ltd.
		intermediate
abutment for fixed
or removable
bridgework, and for
overdentures.		dentures, or as a single
tooth replacement
Implant
Material	Ti-6Al-4V ELI	Ti6Al4V (ASTM
F136)	Ti6Al4V ELI- Titanium
Alloy	Ti6Al4V (ASTM F136)	Ti-6Al-4V ELI	Ti-6Al-4V ELI	Ti-6Al-4V ELI
Implant
Surface
Treatment	Sand-blasted, large
grit, Acid-Etched
(SLA)	Implant -
Resorbable Blast
Texture (RBT)
media (tricalcium
phosphate)
Collar - micro-
machining grooves
(Laser-Lok)	Sand-blasted, Acid-
Etched	Integra-CP®
(hydroxyapatite coated),
Integra-Ti®(grit-blasted
and acid etched)	Sand-blasted, large grit, Acid-
Etched (SLA)	Sand-blasted, large grit,
Acid-Etched (SLA)	Sand-blasted, large grit,
Acid-Etched (SLA)
Sterilizatio
n Method	Gamma
Sterilization	Gamma
Sterilization	Gamma Sterilization	Gamma Sterilization	Gamma Sterilization	Gamma Sterilization	Gamma Sterilization
Implant/
Abutment
Interface	Advanced, Advanced
+, Dynamic, PAI, PAI
TC- Hex internal
interface
Dynamic Conical,
Dynamic Conical MC,
PCA- Hex Internal
interface with coronal
conical taper	Internal Hex	Internal Hexagon	Internal 2.5mm
connection	Hex Internal interface with
coronal conical taper	Hex Internal interface	Hex Internal interface

The Subject device implant's material (Ti6A4V ELI) is substantially equivalent to the primary Predicate device (Ti6Al4V), both adhering to the standard ASTM F136. The Subject device implant lengths are similar to the primary Predicate device and the implant diameters are very close; 4.2mm for the Subject device and 4.6mm for the slimmest device cleared in K172576.

All of the Subject device length and diameter combinations are covered by the K103089 reference device. They are highly similar to the 4.0mm x 6mm Reference device K092035 implants.

The Subject device implant bodies with a machined neck are substantially equivalent to K092035 Reference device Subject device PAI and PAI TC implant bodies have a machined neck of 1.5mm and Dynamic Conical MC implant bodies have a machined neck of 0.8mm, which is the same or less than K092035 Reference device's 1.5mm machined neck. The implant bodies' lengths and diameter are highly similar to the Subject devices; K092035 Reference device with 5mm and 6mm lengths and 4.0mm diameter are shorter/same

15

length and narrower compared to the Subject device PAI, PAI TC, and Dynamic Conical MC implant bodies of 6mm lengths and 4.2mm, 5.0, and 6.0mm diameters.

The Subject device implants are made of the same material as Reference devices K103089, K210117, K220200, and K112795.

All Subject device implants are sterilized by gamma radiation and packaged the same as the Reference devices K210117 and K2020. The Subject device implants are single user, the same as the Reference Devices K210117, K22020, and K112795. The Subject device platform switching is supported by the reference device K220200.

Technological Characteristics Comparison Table - Abutment Design
Design
Parameter	Subject Device
Paltop Short Implants

Paltop Advanced
Dental Solutions Ltd | Reference Device
Paltop Conical Implant System
(K220200)

Paltop Advanced
Dental Solutions Ltd | Reference Device
Paltop Narrow Implant
(K210117)

Paltop Advanced
Dental Solutions Ltd | Reference Device
Paltop Advanced Dental Solutions
System
(K112795)

Technological Characteristics Comparison Table - Abutments

16

Technological Characteristics Comparison Table - Abutment Design
Design
Parameter	Subject Device
Paltop Short Implants		Reference Device
Paltop Conical Implant System
(K220200)					Reference Device
Paltop Narrow Implant
(K210117)						Reference Device
Paltop Advanced Dental Solutions
System
(K112795)
	Paltop Advanced
Dental Solutions Ltd					Paltop Advanced
Dental Solutions Ltd					Paltop Advanced
Dental Solutions Ltd						Paltop Advanced
Dental Solutions Ltd
Healing Caps	Design	GH	PD	Max
CA	PH	Design	GH	PD	Max
CA	PH	Design	GH	PD	Max
CA	PH		Design	GH	PD	Max
CA	PH
	Straight	2, 3,
5	4.5	0	0.5	Straight
Straight	2.0
2, 3,	3
4.5	0
0	0
0	Straight
Concave	2, 3, 5
4, 5,
6, 7	4
4.4	0
0	0
0		Concave	1,
2, 3	4.5	0	0
	Straight	2, 3,
5	5.5	0	0	Straight	2, 3,
5	4.5	0	0							Concave	1,
2, 3	5.5	0	0
	Straight	2, 4,
6	6.5	0	1	Concave	4, 5,
7				Blue Anodized Finish
	Concave	4, 6,
7	4.5	0	1	Concave	2, 3,
5,7	6.0	0	0							No Finish
	Concave	2, 4,
6	6.5	0	1
						Gold Anodized Finish
	Wide Platform Healing Caps have a Purple
Anodized Finish. Standard Platform
Healing Caps are not Anodized.
Image: Healing Caps
Straight
Abutments	Design	GH	PD	Max
CA	PH	Design	GH	PD	Max
CA	PH							Design	GH	PD	Max
CA	PH
	Anatomic
Straight	1, 2,
3, 4	6.16	0	7.6	Knife-
Edge	0.8	3.8	0	8							Narrow
Straight	0
1, 2,
3	3.9
4.5,
5.5	0
0	8
8
	Concave
Anatomic
Straight	1, 2,
3, 4	6.16	0	7.6	Concave	1, 2,
3, 4,
5	4.5	0	7.5			N/A
						Concave	1, 2,
3, 4,
5	6.0	0	7.5							Anatomic	1,
2,
3	4.9,
4.7,
4.63	0	8


SAS Abutment	Design	GH	PD	Max
CA	PH	Design	GH	PD	Max
CA	PH
	Snap- On
Abutment	1, 2,
3
1, 2	4.5
6.0	0
0	4,
5.5
5.5	Snap- On
Abutment	1,
2,
3,
4, 5	4.5	0	4,
5.5
	Up to 30 days use (PEEK portion)
Image: Abutment						1,
2,
3,
4, 5
SAS Abutment

up to 30 days use (PEEK portion) | 6.0 | 0 | 4,
5.5 | | | N/A | | | | N/A | | | | | | |

17

Traditional 510(k) Submission

Technological Characteristics Comparison Table – Abutment Design
Design
Parameter	Subject Device
Paltop Short Implants		Reference Device
Paltop Conical Implant System
(K220200)		Reference Device
Paltop Narrow Implant
(K210117)		Reference Device
Paltop Advanced Dental Solutions
System
(K112795)
	Paltop Advanced
Dental Solutions Ltd		Paltop Advanced
Dental Solutions Ltd		Paltop Advanced
Dental Solutions Ltd		Paltop Advanced
Dental Solutions Ltd
Ball Abutment	GH
4	PD
Max CA
4.5
0	PH
3	GH
1, 2, 3, 4, 5	PD
Max CA
4.5
0	PH
2.8	N/A		GH
1, 2, 3	PD
Max CA
4.5
0	PH
3.1
Titanium
Temporary
Abutment	Design
Temporary
Engage	GH
0.5,
2, 3	PD
4.3	Max CA
0	PH
5
(min)	Design
Temporary
Engage	GH
0.5,
2, 3	PD
4.25	Max CA
0	PH
5
(min)	N/A
	Design
Temporary
Non-
Engage	GH
0.5,
2, 3	PD
5.7	Max CA
0	PH
5
(min)	Design
Temporary
Non-
Engage	GH
0.5,
2, 3	PD
4.25	Max CA
0	PH
5
(min)

18

Overall, the Subject device abutments are highly similar to the Reference devices K210117, K220200, and K112795.

Abutment designs are the same in principle as the Reference devices found in K210117, K220200, and K112795. Critical abutment dimensions, such as the gingival height, prosthetic diameter, and post heights are highly similar between the Subject devices and K210117, K220200, and K112795 Reference device abutment designs. Subject device abutments and screws are fabricated from the same materials as the Reference devices K210117 and K220200.

Sterilization and packaging of the sterile Subject device abutments and screws are the Reference devices K210117 and K220200.

Cleaning and sterilization of non-sterile Subject device abutments and screws are the Reference devices K210117 and K220200.

Cover Screws

The Subject device Cover Screw is highly similar to the Reference devices K220200 and K112795 cover screws, with a slightly larger platform diameter.

Healing Caps

The Subject device Healing Caps are highly similar to the K210117, K220200, and K112795 Reference device Healing Caps, with slight differences in gingival height, anodization color, prosthetic diameter and post height dimensions. There is an additional gingival height option in the Subject device. Implant/abutment connection is the same as Reference device K112795 with an additional wider platform and differs from the implant/abutment connection of Reference device K220200. Implant/abutment connection interface is the same as Reference Device K210117 in wider platforms.

Straight Abutments

The Subject device Straight Abutments are highly similar to the K220200 and K112795 Reference device Straight Abutments, with slight differences in design, gingival height, prosthetic diameter, and post height dimensions. lmplant connection is the same as Reference device K112795 in a wider platform and differs from the implant connection of Reference device K220200.

Snap-On Abutment System (SAS) Abutments

The Subject device Snap-On Abutment System (SAS Abutments) are similar to the K220200 Reference device SAS Abutments with slight differences in gingival height, platform diameter, and a different implant-abutment connection.

Ball Abutment

The Subject device Straight Ball Abutment is highly similar to the K220200 and K112795 Reference device Ball Abutments, with slight differences in post height, and prosthetic diameter. Implant abutment connection and platform is the same as Reference device K112795.

Temporary Abutments

The Subject device Titanium Temporary Abutments (engaging and non-engaging) are highly similar to the

19

K210117 and K220200 Reference device Titanium Temporary Abutments (engaging and non-engaging) differing in prosthetic diameter. Reference Device K210117 has the same implant abutment connection with a different platform, and the implant abutment connection of the Subject device differs from the implant abutment connection of K220200.

Minor differences in the external thread designs, dimensions, abutment designs, sizes, or implant abutment connections between the Subject device, the primary Predicate device, and the Reference devices do not affect substantial equivalence.

The gingival height dimensions of the Subject device abutment components (0.5-7 mm) are highly similar to and encompassed by the K210117, K220200, and K112795 Reference devices (0-7 mm).

The prosthetic diameters of the Subject device abutment components (4-6.5 mm) are highly similar to the K210117, K220200, and K112795 Reference devices (3-6 mm).

Overall, the Subject, primary Predicate and Reference devices encompass a similar range of physical dimensions. Paltop Short Implants are only indicated for use with straight abutments; therefore, fatigue testing is not required.

20

NON-CLINICAL PERFORMANCE TEST DATA

Comparative testing in the form of Pull-Out, surface area and BIC testing was performed to ensure that the performance of the subject device is appropriate for its intended use.

According to 'Root-form Endosseous Dental Implants and Endosseous Dental Abutments - Class II Special Controls Guidance Document for Industry and FDA Staff', static and dynamic testing were not required to be performed for the purposes of this submission. As stated in the FDA guidance document, it is recommended to conduct fatigue testing on devices which : 'consist of angled abutments; are implant or abutment designs that are significantly different from predicate devices; or have design features or technological characteristics that have not been previously cleared for market'. Since none of these criteria are applicable for the Paltop Short Implants, it was concluded that fatigue testing is not required.

The Subject devices have the same nature of body contact, contact duration, material formulation, surface treatment, and sterilization methods compared to the sponsor's Reference device.

Biological Evaluation of the Subject device was performed according to ISO 10993-1.

Test results from ISO 10993-5 Cytotoxicity testing is leveraged from the sponsor's Reference device K210177 to support suitable biocompatibility of the Subject device.

Endotoxin testing on the Subject device or suitable test specimens are performed following USP and USP according to the sponsor's endotoxin sampling plan, and testing is leverage from the sponsor's Reference device K210117.

Test results and Sterilization revalidations performed for the sponsor's Reference devices K210117 and Subject Devices are leveraged to demonstrate suitable sterilization of the Subject device sterile components.

Shelf-life testing is leveraged from the sponsor's Reference device K210117 to support shelf-life of Subject device sterile components.

Cleaning and sterilization validations for non-sterile components which may be modified and require subsequent sterilization is leveraged from the Reference device K210117.

Non-clinical worst-case MRI review was performed to evaluate the Subject device components in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, and fixation screws) and material composition. The Subject devices are composed of material that is electrically nonconductive, nonmetallic, and nonmagnetic. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.

No clinical data were included in this submission.

21

CONCLUSION

The Indications for Use statements for the Subject, primary Predicate, and Reference devices are highly similar.

The technological characteristics, mode of operation, and materials of the Subject device are the same or highly similar to that of the primary Predicate and Reference devices. Slight differences in design dimensions do not affect the intended use of the device and are mitigated or supported through non-clinical performance testing results.

Overall, the data included in this premarket notification demonstrate substantial equivalence of Subject device to the sponsor's Predicate device.