Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical dental implant and associated components, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The performance studies focus on mechanical and biological properties.

Therapeutic

Yes
The device is used to restore chewing function and provides support for prosthetic devices, which are therapeutic applications aimed at improving a patient's health and quality of life.

Diagnostic

No

This device is an implantable dental device designed to support prosthetic devices and restore chewing function, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical endosseous dental implant made of titanium alloy, along with associated physical components like abutments and screws. It is surgically implanted and has physical characteristics like thread configurations and surface treatments.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes a surgical and restorative application for supporting prosthetic devices in the mouth to restore chewing function. This is a direct medical intervention on the patient's body.
Device Description: The device is described as endosseous dental implants and associated components, which are physically implanted into the bone.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.

The device is a medical device used for surgical and restorative purposes, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Paltop Narrow Implant is indicated for use in surgical and restorative applications for placement in the mandbular 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 Pattop Narrow Implant is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

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

DZE, NHA

Device Description

This submission expands the Predicate Narrow Implant device to include 3.0 mm diameter implants, additional implant thread configurations and additional prosthetic components to the previously cleared Paltop Narrow Implant (K130462).

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.

Paltop Narrow Implant are one- and two-stage endosseous screw type dental implants with associated abutments. The implants, titanium abutment screws are fabricated from a Titanium-6 Aluminum 4 Vanadium ELI titanium alloy which conforms to ASTM F136. The Paltop Narrow Implants are surface treated with SLA (Sand-blasted, Large Grit, Acid Etched).

The implants are available in three thread/body configurations: Advanced, Advanced+, and Dynamic. The Advanced, Advanced+ and Dynamic implants have micro threads at the neck. All implants have a parallel coronal and mid-section area with an apical taper. The families have slight differences in thread profile and either a passive or active apex. The 3.0 mm diameter implants are prosthetically compatible with the previously cleared Paltop Narrow Implant (K130462) prosthetic devices.

This submission introduces Single-Unit Abutments for the Paltop Narrow Implant device. The submission replaces the original straight Multi-Unit Abutments from the K130462 submission and includes additional gingival heights. The submission also introduces an angulated Multi-Unit titanium abutment, all compatible with the Paltop Narrow Implant device. The submission expands the compatible prosthetic components to include new temporary titanium abutments and healing caps compatible with Single-Unit and Multi-Unit titanium implant abutments.

The Subject device implants may be used with the Predicate device abutments previously cleared under K130462, based on non-clinical performance bench testing provided in this submission.

The Subject device abutments may be used with the Predicate device implants previously cleared under K130462, based on non-clinical performance bench testing provided in this submission. The only exception is the implant cover screw (P/N 80-70100) which is specific to the 3.0 mm diameter implants in this submission.

The Subject device Multi-Unit Abutment components such as copings/interfaces, temporary abutments, cylinders, and screws may be used with the Predicate device Multi-Unit Abutments previously cleared under K130462 based on non-clinical performance bench testing provided in this submission.

All implants and prosthetic components are one-time use devices. All Subject devices in this submission are provided sterile and sterilized by gamma irradiation except for Single-Unit and Multi-Unit copings and all replacement screws which are provided non-sterile. Devices provided as non-sterilized by steam.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws

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)

Fatigue testing was performed according to the requirements of ISO 14801:2016, Dentistry – Implants – Dynamic loading test for Endosseous Dental Implants. The worst-case scenario was chosen based on the FDA Guidance, Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.

Bone to implant contact area comparison and pull- out testing was performed to compare the Subject, Predicate and Reference devices.

Test results and Biological Evaluation performed on the sponsor's Predicate and Reference devices to demonstrate suitable biocompatibility of the Subject device. The evaluation included review of published literature, internal routine monitoring data related to implant modified surface treatment and post-market surveillance data on Paltop implants subject to the same modified surface treatment and cleaning process as the Subject device.

The published literature evaluated bone changes on patients implants made from the same material and with the same surface treatment as the Subject device. Implants of varying diameters and lengths were placed in male and female adult population patients. Placement locations varied and included placement in extraction sockets, healed bone, and grafted bone locations. Bone levels were evaluated at time of abutment placement and final loading and a follow-up evaluation time from final abutment insertion which ranged from 11 months to 4 years, with an average of (2.3 years). Mesial and distal surfaces were examined and graded as bone improved, bone maintained, and bone decreased. A total of 174 surfaces were graded (87 implants). Results demonstrated bone level improvement or maintenance for 92% of the implants. Bone level decreases identified were less than 1 mm, well within accepted levels. 100% of the implants met criteria for successful implant osseointegration.

Review of historical SEM/EDS data was performed on Paltop implants made from the same material and surface treatment process, and same lot numbers as the published literature. Data included SEM images to quantify residual particles over a portion of each implant which was then extrapolated to estimate total particles over the entire length of the implant.

Review of post market surveillance data and was performed to identify any significant trends in osseointegration failures. The results indicated failure rates below industry levels.

The Biological Evaluation and review of published literature, internal in-process monitoring, and post-market surveillance data support a conclusion that residual aluminum particle levels, if present, as demonstrated from the manufacturer's specific surface treatment and included assessment, do not have negative impact on osseointegration and implant survival.

Confirmatory endotoxin testing was performed according the acceptance criteria defined in USP .

Test results and sterilization validations performed for the sponsor's Predicate and Reference devices demonstrate suitable sterilization of the Subject device sterile components.

A cleaning validation, and a sterilization according to ISO 17665-1, were performed for the Subject device non-sterile components and sterile components which may be modified and require subsequent sterilization.

The results of the non-clinical testing demonstrate conformance with testing requirements and support a finding of substantial equivalence with respect to the Subject and Predicate device.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K130462

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K102436, K112795, K131451

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

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

Paltop Advanced Dental Solutions, Ltd % Chris Brown Manager Aclivi, LLC 3250 Brackley Drive Ann Arbor, Michigan 48105

Re: K210117

Trade/Device Name: Paltop Narrow Implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: November 1, 2021 Received: November 3, 2021

Dear Chris Brown:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

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

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 Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K210117

Device Name Paltop Narrow Implant

Indications for Use (Describe)

The Paltop Narrow Implant is indicated for use in surgical and restorative applications for placement in the mandbular 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 Pattop Narrow Implant is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

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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K210117 510(k) Summary Paltop Advanced Dental Solutions, Ltd Paltop Narrow Implant

ADMINISTRATIVE INFORMATION

| Manufacturer Name | Paltop Advanced Dental Solutions, Ltd
Hashita 5, Industrial Park
Caesarea 3088900
Israel |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | +(972) 4-627 1711 |
| Fax: | +(972) 4-627 5363 |
| Official Contact | Zina Gurgov, Director of QA/RA
Email: zgurgov@keystonedental.com |
| Consultant | Chris Brown, BSEE
Aclivi, LLC
3250 Brackley Drive
Ann Arbor, Michigan 48105
Telephone: +1 (810) 360-9773
E-mail: acliviconsulting@gmail.com |

Date submitted: 11/30/2021

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:	Paltop Narrow Implant
Common Name:	Implant, Dental, Endosseous, Root-Form
Classification Name:	Endosseous dental implant
Classification Regulation	21 CFR 872.3640
Device Class:	Class II
Product Code:	DZE, NHA
Review Panel:	Dental
Reviewing Branch:	Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1) Dental Devices (DHT1B)

PREDICATE DEVICE INFORMATION

The devices within this submission are substantially equivalent in indications, intended use and design principles to the following predicate and reference devices:

510(k)	Predicate Device Name	Company Name
K130462	Paltop Narrow Implant	Paltop Advanced Dental Solutions

	Reference Predicate Device Name
K102436	NobelActive 3.0	Nobel Biocare USA, LLC
K112795	Paltop Advanced Dental Solution System	Paltop Advanced Dental Solutions
K131451	Paltop Dental Sterile Accessories	Paltop Advanced Dental Solutions

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DEVICE DESCRIPTION