K Number
K220200
Device Name
Paltop Conical Implant System
Date Cleared
2022-05-25

(121 days)

Product Code
Regulation Number
872.3640
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Paltop Conical 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. Narrow diameter implants are intended 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. The Paltop Conical Implant System is also indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Device Description
The Paltop Conical Implant System which comprises endosseous root-form dental implants, mating abutment screws, and other associated components for single-unit, multi-unit, and overdenture restorations. 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 Conical Implant System implants are one- and two-stage endosseous screw type dental implants with associated compatible abutments, screws, and other associated accessory components. The Paltop Conical Implant System prosthetic components include healing caps, and multi-unit abutments which are available in straight or angulated configurations. Prosthetic devices used with the dental implant abutments in this submission may be screw-retained or cemented. The implants, titanium abutment screws are fabricated from a Titanium-6 Aluminum 4 Vanadium ELI titanium alloy (Grade 23) which conforms to ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The Subject device implants are surface treated with SLA (Sand-blasted, Large Grit, Acid Etched). Immediate temporary abutments include a PEEK (Polyether ether Ketone) material sleeve, and the SAS abutment includes a PEEK healing cap/coping. All implants and prosthetic components are one-time use device components are provided sterile and sterilized by gamma irradiation except for Single-Unit and Multi-Unit copings, SAS Abutment components and all replacement screws which are provided non-sterile. Devices provided as non-sterile are sterilized by steam.
More Information

No
The summary describes a standard dental implant system and its components, focusing on materials, testing, and intended use. There is no mention of AI or ML in the device description, intended use, or performance studies.

Yes
The device is described as a "Paltop Conical Implant System" which is indicated for use in surgical and restorative applications by being placed in the jaw bone to support prosthetic devices (artificial teeth) and restore the patient's chewing function. This directly serves to treat a condition (loss of teeth and chewing function) in a patient, fitting the definition of a therapeutic device.

No

This device is designed for surgical and restorative applications to provide support for prosthetic devices, not to diagnose a condition.

No

The device description explicitly details physical components made of titanium alloy and PEEK, which are surgically implanted. This is a hardware device, not software only.

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

Here's why:

  • Intended Use: The intended use clearly states the device is for surgical and restorative applications within the bone of the jaw to support prosthetic devices for restoring chewing function. This is a direct intervention on the patient's body.
  • Device Description: The description details endosseous dental implants, abutments, screws, and other components that are surgically implanted into the patient's mouth.
  • Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing samples from the human body (blood, urine, tissue, etc.).
    • Providing information about a patient's health status, diagnosis, or monitoring.
    • Using reagents or calibrators.

The device is a medical device used for surgical implantation and prosthetic support, not for in vitro diagnostic testing.

N/A

Intended Use / Indications for Use

The Paltop Conical 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. Narrow diameter implants are intended 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. The Paltop Conical Implant System is also indicated 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

The purpose of this submission the marketing clearance for the Paltop Conical Implant System which comprises endosseous root-form dental implants, mating abutment screws, and other associated components for single-unit, multi-unit, and overdenture restorations.

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 Conical Implant System implants are one- and two-stage endosseous screw type dental implants with associated compatible abutments, screws, and other associated accessory components. The Paltop Conical Implant System prosthetic components include healing caps, and multi-unit abutments which are available in straight or angulated configurations. Prosthetic devices used with the dental implant abutments in this submission may be screw-retained or cemented.

The implants, titanium abutment screws are fabricated from a Titanium-6 Aluminum 4 Vanadium ELI titanium alloy (Grade 23) which conforms to ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The Subject device implants are surface treated with SLA (Sand-blasted, Large Grit, Acid Etched). Immediate temporary abutments include a PEEK (Polyether ether Ketone) material sleeve, and the SAS abutment includes a PEEK healing cap/coping.

All implants and prosthetic components are one-time use device components are provided sterile and sterilized by gamma irradiation except for Single-Unit and Multi-Unit copings, SAS Abutment components and all replacement screws which are provided non-sterile. 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

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)

Fatigue testing:

  • Performed according to the requirements of ISO 14801:2016, Dentistry – Implants – Dynamic loading test for Endosseous Dental Implants.
  • 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.

Biological Evaluation:

  • Performed according to ISO 10993-1.
  • Cytotoxicity testing results leveraged from the sponsor's Primary Predicate and Reference devices (ISO 10993-5) to support suitable biocompatibility of the Subject device.

Endotoxin testing:

  • Performed on the Subject device or suitable test specimens following USP and USP according to the sponsor's endotoxin sampling plan.

Sterilization:

  • Test results and sterilizations performed for the sponsor's Primary Predicate devices are leveraged to demonstrate suitable sterilization of the Subject device sterile components.
  • Sterilization validations for non-sterile components which may be modified and require subsequent sterilization are leveraged from the Primary Predicate device.

MRI review:

  • 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, abutments, and fixation screws) and material composition.
  • 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.

Key Results:

  • 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 Primary Predicate device.
  • ISO 14801 mechanical performance testing performed on worst-case constructs of the Subject device to demonstrate suitability for intended use of the Subject device implant platform, gingival height, and post correction angles combinations.

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.

K210117

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.

K112795

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

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: K220200

Trade/Device Name: Paltop Conical Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: April 28, 2022 Received: April 29, 2022

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.

1

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/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

2

Indications for Use

510(k) Number (if known)

K220200

Device Name Paltop Conical Implant System

Indications for Use (Describe)

The Paltop Conical 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. Narrow diameter implants are intended 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. The Paltop Conical Implant System is also indicated 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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3

510(k) Summary K220200 Paltop Advanced Dental Solutions, Ltd Paltop Conical Implant System

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 | |
| Date submitted: | 5/25/2022 | |

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:Paltop Conical Implant System
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 primary predicate and reference devices:

510(k)Primary Predicate Device NameCompany Name
K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions
510(k)Reference Device NameCompany Name
K112795Paltop Advanced Dental Solution SystemPaltop Advanced Dental Solutions

4

DEVICE DESCRIPTION

The purpose of this submission the marketing clearance for the Paltop Conical Implant System which comprises endosseous root-form dental implants, mating abutment screws, and other associated components for single-unit, multi-unit, and overdenture restorations.

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 Conical Implant System implants are one- and two-stage endosseous screw type dental implants with associated compatible abutments, screws, and other associated accessory components. The Paltop Conical Implant System prosthetic components include healing caps, and multi-unit abutments which are available in straight or angulated configurations. Prosthetic devices used with the dental implant abutments in this submission may be screw-retained or cemented.

The implants, titanium abutment screws are fabricated from a Titanium-6 Aluminum 4 Vanadium ELI titanium alloy (Grade 23) which conforms to ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The Subject device implants are surface treated with SLA (Sand-blasted, Large Grit, Acid Etched). Immediate temporary abutments include a PEEK (Polyether ether Ketone) material sleeve, and the SAS abutment includes a PEEK healing cap/coping.

All implants and prosthetic components are one-time use device components are provided sterile and sterilized by gamma irradiation except for Single-Unit and Multi-Unit copings, SAS Abutment components and all replacement screws which are provided non-sterile. Devices provided as non-sterile are sterilized by steam.

| Implant
Type | Implant Body
Diameter (mm) | Implant Platform
Diameter (mm) | Lengths (mm) |
|--------------------|-------------------------------|-----------------------------------|---------------------|
| Dynamic
Conical | Ø 3.25 | Ø 3.25 | 10, 11.5, 13, 16 |
| | Ø 3.75 | Ø 3.75 | 8, 10, 11.5, 13, 16 |
| | Ø 4.2 | Ø 4.2 | 8, 10, 11.5, 13, 16 |
| | Ø 5.0 | Ø 5.0 | 8, 10, 11.5, 13, 16 |

Paltop Conical Implant System - Implant Sizes

Paltop Conical Implant System - Abutment Types

Subject Device Abutment Designs
Implant
Diameter
(mm)Healing
CapsStraightStraight
Single-UnitStraight
Multi-UnitAngled
Multi-UnitAngledTemporaryTemporary
ImmediateSASStraight Ball
3.25XXXXXXXXXX
3.75XXXXXXXXXX
4.2XXXXXXXXXX
5.0XXXXXXXXXX
Non-
indexedIndexedNon-
indexedNon-
IndexedIndexedIndexedIndexed,
Non-IndexedNon-
IndexedIndexedNon-Indexed
MaterialGrade 23 Titanium Alloy
FinishGold
AnodizeNone

5

INDICATIONS FOR USE

The Paltop Conical Implant System is 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. Narrow diameter implants are intended 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. The Paltop Conical Implant System is also indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

EQUIVALENCE TO MARKETED DEVICE

The Subject device is highly similar to the Primary 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 Primary Predicate/Reference devices.

DeviceIndications for Use Statement
Subject Device
Paltop Conical Implant
SystemThe Paltop Conical 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. Narrow diameter implants are intended 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. The Paltop Conical Implant System is also indicated for immediate loading when good primary
stability is achieved and with appropriate occlusal loading.
Primary Predicate
Device
Paltop Narrow Implant
(K210117)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.
Reference Device
Paltop Advanced Dental
Solutions System
(K112795)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.

Comparison of Indications for Use Statements

The Subject, Primary Predicate and Reference devices have highly similar Indications for Use, differing primarily in device name. The Primary Predicate device was a narrow diameter implant submission and the Reference device included larger diameter implants. The Subject device Indications for Use statement combines the relevant features of both diameter configuration implants into a single statement as the Subject device encompasses both Narrow and standard diameter implants and includes the trade name of the Subject device. These minor differences do not raise new questions of safety or effectiveness as all the Indications for Use statements express equivalent intended use.

Design ParameterSubject DevicePrimary Predicate DeviceReference Device
Paltop Conical Implant System
Paltop Advanced Dental SolutionsPaltop Narrow Implant (K210117)
Paltop Advanced Dental SolutionsPaltop Advanced Dental Solutions System (K112795)
Paltop Advanced Dental Solutions
Regulation #21 CFR 872.364021 CFR 872.364021 CFR 872.3640
Product CodeDZE, NHADZE, NHADZE, NHA
ClassificationClass IIClass IIClass II
MaterialsImplants/Screws - Titanium Ti-6Al-4V ELI
Abutments- Titanium Ti-6Al-4V ELI, PEEKImplants/Screws - Titanium Ti-6Al-4V ELI
Abutments- Titanium Ti-6Al-4V ELI, PEEKImplants/Screws - Titanium Ti-6Al-4V ELI
Abutments- Titanium Ti-6Al-4V ELI or PEEK
Reason for
Predicate/ReferenceNot ApplicableNarrow diameter implant, Implant length,
implant design, implant modified surface,
sterilization, biocompatibility, how providedStandard diameter implants, implant lengths

Comparison of Technological Characteristics

6

Implant Design

Subject DevicePrimary Predicate DeviceReference Device
Design ParameterPaltop Conical Implant System
Paltop Advanced Dental SolutionsPaltop Narrow Implant (K210117)
Paltop Advanced Dental SolutionsPaltop Advanced Dental Solutions System (K112795)
Paltop Advanced Dental Solutions
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 -
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.Dynamic -
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.
Dynamic Conical
D = Implant Body Diameter
IP = Implant Platform DiameterD IP Lengths 3.25 3.25 10, 11.5, 13, 16 3.75 3.75 8, 10, 11.5, 13, 16 4.2 4.2 8, 10, 11.5, 13, 16 5.0 5.0 8, 10, 11.5, 13, 16D IP Lengths 3.0 3.0 10, 11.5, 13, 16D IP Lengths 3.75 3.75 8, 10, 11.5, 13, 16 4.2 4.2 8, 10, 11.5, 13, 16 5.0 5.0 8, 10, 11.5, 13, 16
Mode of OperationProvide support for prosthetic devices,
such as artificial teeth, to restore the
patient's chewing function.Provide support for prosthetic devices,
such as artificial teeth, to restore the
patient's chewing function.Provide support for single and multi-unit
prostheses to restore the patient's chewing
function.
Implant MaterialGrade 23 Titanium AlloyGrade 23 Titanium AlloyGrade 23 Titanium Alloy
Implant Surface
TreatmentSand-blasted, Large grit, Acid-Etched
(SLA)Sand-blasted, Large grit, Acid-Etched
(SLA)Sand-blasted, Large grit, Acid-Etched (SLA)
Sterilization MethodGamma SterilizationGamma SterilizationGamma Sterilization
Implant/
Abutment InterfaceHex Internal interface with coronal
conical taperHex Internal interfaceHex Internal interface

The Subject device implant design material and external threads, and implant lengths are the Primary Predicate and Reference devices. The range of Subject device implant diameters are supported by the Primary Predicate and Reference devices. Implant surface treatment materials and process is the same for the Subject and Primary Predicate devices. The Subject device implants are sterilized by gamma radiation and packaged the same as the Primary Predicate device K210117. The Subject device implants are single use, single user, the same as the Primary Predicate device. The introduction of the Subject device platform switching, and the coronal taper of the implant/abutment interface connection does not affect substantial equivalence nor change the intended use of the devices. Differences in the implant/abutment connections between the Subject and Primary Predicate and Reference devices do not change the intended use and have been mitigated through non-clinical bench performance testing.

7

Technological Characteristics Comparison Table - Abutments

| Comparison | Subject Device
Paltop Conical Implant System
Paltop Advanced Dental Solutions | Primary Predicate Device
Paltop Narrow Implant (K210117)
Paltop Advanced Dental Solutions | Reference Device
Paltop Advanced Dental Solutions System (K112795)
Paltop Advanced Dental Solutions | |
|-----------------------------------------------------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|--|
| Product Code | DZE, NHA | DZE, NHA | DZE, NHA | |
| Regulation | 872.3640, 872.3630 | 872.3640, 872.3630 | 872.3640, 872.3630 | |
| Intended Use | Functional and esthetic rehabilitation of the | Functional and esthetic rehabilitation of the | Functional and esthetic rehabilitation of the edentulous | |
| | edentulous maxilla and mandible | edentulous maxilla and mandible | maxilla and mandible | |
| Reason for Predicate/Reference
Sterilization method - Sterile components | Not Applicable
Gamma Sterilization | Use with small diameter implant, abutment designs
Gamma Sterilization | Use with standard diameter implants, abutment designs
Gamma Sterilization | |
| Sterilization method - non-Sterile | | | Gamma Sterilization | |
| components | Steam sterilization | Steam sterilization | Steam sterilization | |
| Abutment/Screw Material | Grade 23 Titanium Alloy
no finish unless otherwise specified | Grade 23 Titanium Alloy
no finish unless otherwise specified | Grade 23 Titanium Alloy
no finish unless otherwise specified | |
| Use with Implant diameters | 3.25 mm, 3.75 mm, 4.2 mm, 5.0 mm | 3.0 mm, 3.25 mm | 3.75 mm, 4.2 mm, 5.0 mm | |
| Cover Screws (supplied | | | | |
| w/implants) | PD - 3.25 mm, 3.75 mm, 4.2 mm, 5.0 mm | PD - 3.0 mm, 3.25 mm | PD - 3.75 mm, 4.2 mm, 5.0 mm | |
| Healing Caps | Design
GH
PD
Max
CA
PH | Design
GH
PD
Max
CA
PH | Design
GH
PD
Max
CA
PH | |
| | Straight
2
3
0
1 | Straight
2,3,5
4
0
0.25 | Straight
1,2,3
4.5
0
1 | |
| | Straight
2, 3, 5
4.5
0
1 | Concave
4,5,6,7
4.4
0
1 | Concave
1,2,3
5.5
0
1 | |
| | Concave
2,3,4,5,7
4.5
0
1 | Blue anodized finish | No finish | |
| | Concave
2,3,5,7
6.0
0
1 | | | |
| | Gold anodized finish | | | |
| Straight Abutments | Design
GH
PD
Max
CA
PH | n/a | Design
GH
PD
Max
CA
PH | |
| | Knife-edge
0.8
3.8
0
8 | | Narrow
0
3.9
0
8 | |
| | Concave
1,2,3,4,5
4.5
0
7.5 | | Straight
1,2,3
4.5, 5.5
0
8 | |
| | Concave
1,2,3,4,5
6.0
0
7.5 | | Anatomic
1,2,3
4.7
0
8 | |
| Straight Single-Unit Abutment | Design
GH
PD
Max
CA
PH | Design
GH
PD
Max
CA
PH | | |
| | w/Temp
Cylinder
1,2 3,4,5
4.5
0
5
(min) | w/Temp
Cylinder
1,2 3,4
4.5
0
5
(min) | | |
| | w/Interface
Coping
1,2 3,4,5
4.5
0
5.5 | w/Interface
Coping
1,2 3,4
4.5
0
5.5 | n/a | |
| | w/Healing
Cap
1,2 3,4,5
4.5
0
3.5 | w/Healing
Cap
1,2 3,4
4.5
0
3.5 | | |
| Straight Multi-Unit Abutment | Design
GH
PD
Max
CA
PH | Design
GH
PD
Max
CA
PH | Design
GH
PD
Max
CA
PH | |
| | w/Temp
Cylinder
1,2 3,4,5
5
0
5
(min) | w/Temp
Cylinder
1,2 3,4,5
5
0
5
(min) | w/Ti-
Abutment
(Cylinder)
1,2 3
4.5
0
n/s | |
| | w/Interface
Coping
1,2 3,4,5
5
0
4.5
(min) | w/Interface
Coping
1,2 3,4,5
5
0
4.5
(min) | w/Healing
Cap
1,2 3
4.5
0
3.3 | |
| | w/Healing
Cap
1,2 3,4,5
5
0
4.5 | w/Healing
Cap
1,2 3,4,5
5
0
4.5 | | |
| Angulated Multi-Unit Abutment | Design
GH
PD
CA
PH | Design
GH
PD
CA
PH | Design
GH
PD
CA
PH | |
| | 17°w/
Temp Cylinder
3,4.5
5
17
5
(min) | 17°w/
Temp Cylinder
3
5
17
5
(min) | 17°w/
Ti-Abutment
(Cylinder)
2,3
4.5
17
n/s | |
| | 17°w/
Interface
Coping
3,4.5
5
17
4.5
(min) | 17°w/
Interface
Coping
3
5
17
4.5
(min) | 17°w/ Healing
Cap
2,3
4.5
17
3.3 | |
| | 17°w/ Healing
Cap
3,4.5
5
17
4.5 | 17°w/ Healing
Cap
3
5
17
4.5 | | |
| | Design
GH
PD
CA
PH | | | |
| | 30°w/
Temp Cylinder
4
5
30
5
(min) | | | |
| | 30°w/
Interface
Coping
4
5
30
4.5
(min) | | | |
| | 30°w/ Healing
Cap
4
5
30
4.5 | | | |
| Angulated Abutment | Design
GH
PD
CA
PH | n/a | Design
GH
PD
CA
PH | |
| | Knife-edge
0.8
4.5
20
8 | | Angulated
1
4.75
15, 25
8 | |
| | Concave
1,2,3,4,5
4.5
20
7.5 | | Anatomic
1,2,3
4.75,5
15, 25
8 | |
| | | | | |

8

Image /page/8/Figure/0 description: This image is a comparison chart of dental implants and abutments from Paltop Advanced Dental Solutions. The chart compares the Paltop Conical Implant System (Subject Device) to the Paltop Narrow Implant (Primary Predicate Device) and the Paltop Advanced Dental Solutions System (Reference Device). The chart provides information on the design, gingival height (GH), prosthetic diameter (PD), correction angle (CA), and platform height (PH) for various abutments, including temporary abutments, SAS abutments, ball abutments, and straight abutments. The chart also includes information on the temporary use of the abutments, such as up to 90 days or up to 30 days.

PD - Prosthetic Diameter PH – Post Height

Overall, the Subject device abutments are highly similar to the Primary Predicate and Reference devices. Abutment designs are the same in principle, and the introduction of the SAS Abutment is considered a minor variation and combination of the Temporary, Immediate abutment, healing cap and straight abutment concepts. Critical abutment dimensions, such as the Gingival Height, Prosthetic Diameter, Post Correction Angle, and Post Heights are highly similar between the Subject, Primary Predicate and Reference device abutment designs. Subject device Abutments and screws are fabricated from the same materials as the Primary Predicate device. Sterilization and packaging of the sterile Subject device abutments and screws are the Primary Predicate device. Cleaning and sterilization of nonsterile Subject device abutments and screws are the Primary Predicate device.

Cover Screws

The Subject device Cover Screws are highly similar, combining the platform diameters of the Primary Predicate and Reference device Cover Screws.

Healing Caps

The Subject device Healing Caps are highly similar to the Primary Predicate and Reference device Healing Caps, with only slight differences in gingival height, anodization color and prosthetic diameter dimensions, and the implant connection.

Straight Abutments

The Subject device Straight Abutments are highly similar to the Reference device Straight Abutments, with only slight differences in gingival height, prosthetic diameter and post height dimensions, and implant connection.

9

Straight Single-Unit Abutments

The Subject device Straight Single-Unit Abutments are highly similar to the Primary Predicate device Straight Single-Unit Abutments, adding one additional gingival height option and the new implant connection. Interface copings, temporary cylinders, and healing cap accessories as part of two-part abutments are supported by the sponsor's Primary Predicate device. The use of Single-Unit Abutment accessories including limitations for hand modification of cylinders is the same as the Primary Predicate device.

Multi-Unit Abutments

The Subject device Straight Multi-Unit Abutments are the Primary Predicate device Straight Multi-Unit Abutments, differing only in the implant connection.

The Subject device 17° Angulated Multi-Unit Abutments are the Primary Predicate device 17° Angulated Multi-Unit Abutments, including one additional gingival height option and differing in the implant connection. The Subject device 30° Angulated Multi-Unit Abutment is similar to the Primary Predicate device 17° Angulated Multi-Unit Abutment, with a larger correction angle and higher gingival height. These specific changes are supported through non-clinical performance testing of the Subject device.

Interface copings, temporary cylinders, and healing cap accessories as part of two-part abutments are supported by the sponsor's Primary Predicate and Reference devices. The use of Multi-Unit Abutment accessories including limitations for hand modification of cylinders is the same as the Primary Predicate device.

Angulated Abutments

The Subject device Angulated Abutments are highly similar to the Reference device Angulated Abutments, with only slight differences in gingival height and maximum correction and differing in implant connection.

Temporary Abutments

The Subject device Titanium Temporary Abutments (engaging) are highly similar to the Primary Predicate device Titanium Temporary Abutments (engaging) differing only in implant connection.

The Subject device Temporary, Immediate Abutments are highly similar to the Primary Predicate device Temporary Immediate, Abutments, with only slight differences in available prosthetic diameters and differing in implant connection.

SAS Abutments

The Subject device SAS Abutments are similar to the Primary Predicate device Temporary Immediate Abutment and healing caps, and the Reference device Straight abutments, with several slight differences. The Subject device SAS abutment combines the Primary Predicate device temporary immediate abutment technology, where a PEEK sleeve can be used as part of chairside fabricated temporary prosthesis. Otherwise, the PEEK cap is cemented to the SAS abutment and used as a healing abutment. The Subject device PEEK material is the same as the Primary Predicate device PEEK material and is subject to the same time of use limitations. It uses the Reference device Straight abutment technology to use the abutment portion of the SAS abutment as a permanent straight abutment to support a cementretained restoration. Slight differences in Gingival Height, Post Height, and implant connection are present, but are supported and mitigated through non-clinical performance testing of the Subject device.

Ball Abutments

The Subject device Ball Abutments are highly similar to the Primary Predicate and Reference device Ball Abutments, with only slight differences due to two additional gingival height dimensions offered for the implant connection.

10

Overall, minor differences in the Subject device implant external thread designs, dimensions, correction angles and implant connection do not affect substantial equival Height dimensions of the Subject device abutment components (0.5-7 mm) are highly similar to and encompassed by the Primary Predicate and Reference devices (0.5-7 mm). The Prosthetic diameters of the Subject device abutment components (3-6 mm) are highly similar to the Primary Predicate and Reference devices (3.9-5.5 mm).

Any differences in implant abutment designs or dimensions have been mitigated and demonstrated to be suitable for intended use through non-clinical bench performance testing.

NON-CLINICAL PERFORMANCE TEST DATA

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.

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

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 Primary Predicate and Reference devices to support suitable biocompatibility of the Subject device.

Endotoxin testing on the Subject device or suitable test specimens was performed following USP and USP according to the sponsor's endotoxin sampling plan.

Test results and Sterilizations performed for the sponsor's Primary Predicate devices is leveraged demonstrate suitable sterilization of the Subject device sterile components.

Sterilization validations for non-sterile components which may be modified and require subsequent sterilization and is leveraged from the Primary Predicate device.

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 Primary Predicate device.

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, abutments, and fixation screws) and material composition. 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.

11

CONCLUSION

Overall, the Indications for Use statements for the Subject and Primary Predicate devices are highly similar.

Overall, the Technological Characteristics, mode of operation and materials of the Subject device are the same or highly similar to that of the Primary Predicate device. 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. ISO 14801 mechanical performance testing performed on worst-case constructs of the Subject device to demonstrate suitability for intended use of the Subject device implant platform, gingival height, and post correction angles combinations.

Overall, the Subject device and Primary Predicate devices have been demonstrated to be Substantially Equivalent.