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

Device Description

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Paltop Narrow Implant, based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format for specific performance metrics like fatigue life or bone-to-implant contact percentages. Instead, it refers to industry standards and general outcomes. The reported device performance is presented narratively.

Performance Characteristic	Acceptance Criteria (implied/standards referenced)	Reported Device Performance
Fatigue Strength	Conformance to ISO 14801:2016 for dynamic loading	Successfully tested to ISO 14801:2016. Worst-case scenario chosen.
Biocompatibility	Suitable biocompatibility	Demonstrated suitable biocompatibility based on review of published literature, internal routine monitoring data, and post-market surveillance data.
Osseointegration	Successful osseointegration, industry-accepted bone level changes	92% of implants showed bone level improvement or maintenance; bone level decreases less than 1mm; 100% met criteria for successful osseointegration.
Implant Survival Rate	Failure rates below industry levels	Post-market surveillance indicated failure rates below industry levels.
Residual Aluminum Particles	No negative impact on osseointegration and implant survival	Evaluation supported previous findings that residual aluminum particles (if present) from specific surface treatment do not negatively impact osseointegration and implant survival.
Endotoxin Levels	Conformance to USP <161>	Confirmatory endotoxin testing performed according to USP <161> acceptance criteria.
Sterilization (Sterile Components)	Suitable sterilization	Demonstrated suitable sterilization based on predicate/reference device validations.
Sterilization (Non-Sterile Components)	Suitable sterilization (cleaning validation, ISO 17665-1)	Cleaning validation and sterilization per ISO 17665-1 performed for non-sterile components and components requiring subsequent sterilization.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a test set sample size for each specific non-clinical test in terms of a number of devices. It refers to general testing.

For the bone changes evaluation (part of biocompatibility/osseointegration): "A total of 174 surfaces were graded (87 implants)."
Data provenance: The bone changes evaluation references "published literature" on patients, suggesting retrospective (or possibly prospective clinical studies mentioned in the literature). "Internal routine monitoring data" and "post-market surveillance data" are mentioned, indicating real-world data collection, likely retrospective for surveillance and ongoing for monitoring. The manufacturer is Paltop Advanced Dental Solutions, Ltd, Hashita 5, Industrial Park, Caesarea 3088900, Israel.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document doesn't specify the number or qualifications of experts used to establish "ground truth" for the test set. For the bone level evaluation, it states "Mesial and distal surfaces were examined and graded." It is implied that these evaluations were done by qualified clinical professionals as part of the published literature or internal monitoring, but no specific details are provided.

4. Adjudication Method

No adjudication method is mentioned for any of the evaluations (e.g., bone level grading, or evaluation of non-clinical tests). The document implies acceptance based on test results meeting standards or being comparable to predicate devices.

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

No MRMC comparative effectiveness study is mentioned. This device is an endosseous dental implant, not an AI diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not applicable.

6. Standalone Performance Study

The primary studies detailed are "non-clinical bench performance testing." This refers to laboratory testing of the device itself (fatigue, pull-out, etc.) and biological evaluations based on literature review and historical data, which are "standalone" in the sense that they assess the device's physical and biological properties. There is no human element being assessed.

7. Type of Ground Truth Used

The ground truth used several types:

Industry Standards: For fatigue testing (ISO 14801:2016), endotoxin testing (USP <161>), and sterilization (ISO 17665-1).
Clinical Outcomes Data: For osseointegration and implant survival (from published literature and post-market surveillance). This includes "bone level improvement or maintenance" and "failure rates below industry levels."
Analytical Data: SEM/EDS data for residual particles.
Comparison to Predicate/Reference Devices: Demonstrating similarity in design and performance to already cleared devices.

8. Sample Size for the Training Set

The document does not mention a "training set" or "training data" in the context of an algorithm or AI. This is a medical device (dental implant) that undergoes physical and biological performance testing, not a machine learning model.

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

Not applicable, as there is no training set for an algorithm described in this document.

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, LtdHashita 5, Industrial ParkCaesarea 3088900Israel
Telephone:	+(972) 4-627 1711
Fax:	+(972) 4-627 5363
Official Contact	Zina Gurgov, Director of QA/RAEmail: zgurgov@keystonedental.com
Consultant	Chris Brown, BSEEAclivi, LLC3250 Brackley DriveAnn Arbor, Michigan 48105Telephone: +1 (810) 360-9773E-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

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.

INDICATIONS FOR USE

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.

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Comparison of Indications for Use Statements

Device	Indications for Use Statement
Subject DevicePaltop NarrowImplant	The Paltop Narrow Implant is indicated for use in surgical and restorative applications for placement in the mandibularcentral, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space islimited by the adjacent teeth and roots, to provide support for prosthetic devices, such as artificial teeth, in order torestore the patient's chewing function. The Paltop Narrow Implant is indicated also for immediate loading when goodprimary stability is achieved and with appropriate occlusal loading.
PredicateDevicePaltop NarrowImplant(K130462)	The Paltop Narrow Implant is indicated for use in surgical and restorative applications for placement in the mandibularcentral, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space islimited by the adjacent teeth and roots, to provide support for prosthetic devices, such as artificial teeth, in order torestore the patient's chewing function. The Paltop Narrow Implant is indicated also for immediate loading when goodprimary stability is achieved and with appropriate occlusal loading.
ReferenceDeviceNobelActive 3.0(K102436)	The NobelActive 3.0mm implant is indicated for use in the treatment of missing maxillary lateral incisors or themandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewingfunction in partially endentulous patients. The NobelActive 3.0 implants may be put into immediate function provide thatstability requirements detailed in the manual are satisfied.
ReferenceDevicePaltop AdvancedDental SolutionsSystem (K112795)	The Paltop Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone ofthe upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient'schewing function. The Paltop Dental Implant System is indicated also for immediate loading when good primary stabilityis achieved and with appropriate occlusal loading.
ReferenceDevicePaltop DentalSterile Accessories(K134151)	The Paltop Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone ofthe upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient'schewing function. The Paltop Dental Implant System is indicated also for immediate loading when good primary stabilityis achieved and with appropriate occlusal loading.

The Subject and Predicate devices have identical Indications for Use, supporting a finding of substantial equivalence. Minor differences in the wording between the Subject device and the NobelActive Reference device do not affect the intended use of the device and demonstrate the use of a 3.0 mm diameter implant in a previously cleared device. The Paltop K112795 and K131451 Reference devices have a highly similar Indications for Use statement which does not change the intended use of the device to restore a patient's chewing function. All Predicate and Reference devices are intended to provide support for dental prostheses.

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Comparison of Technological Characteristics

DesignParameter	Subject Device	Predicate Device	Reference Device	Reference Device	Reference Device
	Paltop Narrow ImplantPaltop Advanced Dental Solutions	Paltop Narrow Implant (K130462)Paltop Advanced Dental Solutions	NobelActive 3.0 (K102436)Nobel Biocare	Paltop Advanced Dental SolutionsSystem (K112795)Paltop Advanced Dental Solutions	Paltop Dental SterileAccessories (K131451)Paltop Advanced DentalSolutions
Regulation #	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, NHA	DZE, NHA	DZE, NHA	DZE, NHA
Classification	Class II	Class II	Class II	Class II	Class II
Materials	Implants/Screws - Titanium Ti-6Al-4V ELIAbutments-Titanium Ti-6Al-4V ELI, PEEK	Titanium Ti-6Al-4V ELI	Implants - CP TitaniumAbutments - TitaniumVanadium Alloy, PEEK	Implants/Screws - Titanium Ti-6Al-4V ELIAbutments-Titanium Ti-6Al-4V ELI or PEEK	Abutments-Titanium Ti-6Al-4V ELI orPEEK
Reason forPredicate/Reference	Not Applicable	Narrow Platform Implant, Implantlength, implant design, implantmodified surface, prostheticconnection, sterilization,biocompatibility, how provided	3.0 mm implant diameter,implant design	Multi-unit angulated abutmentdesign	Sterile packaging ofprosthetic components

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Implant Designs

DesignParameter	Subject Device	Predicate Device	Reference Device
	Paltop Narrow ImplantPaltop Advanced Dental Solutions	Paltop Narrow Implant (K130462)Paltop Advanced Dental Solutions	NobelActive 3.0 (K102436)Nobel Biocare
Implant DesignAdvanced	Endosseous screw-type implant with internalhex connectionParallel coronal and midsection, microthreads on neck, double leaded "V" shapeprogressive thread, tapered apically, roundedpassive apex.Diameter - Ø3.0 mmTotal length - 10, 11.5, 13, 16 mm	Endosseous screw-type implant withinternal hex connection.Advanced - Parallel coronal andmidsection, micro threads on neck, doubleleaded "V" shape progressive thread,tapered apically, rounded passive apex.Diameter - Ø3.25 mmTotal length - 10, 11.5, 13, 16 mm	Endosseous screw-type implant withinternal morse taper/hex connection.Parallel midsection with double lead threadtapered apically, active apex.Diameter - Ø3.0 mmTotal length - 10, 11.5, 13, 15 mm
Implant DesignAdvanced +	Endosseous screw-type implant with internalhex connection- Parallel coronal and midsection, microthreads on neck, double leaded "V" shapeprogressive thread, tapered apically, activeapex.Diameter - Ø3.0 mmTotal length - 10, 11.5, 13, 16 mm	Endosseous screw-type implant withinternal hex connection.Advanced - Parallel coronal andmidsection, micro threads on neck, doubleleaded "V" shape progressive thread,tapered apically, rounded passive apex.Diameter - Ø3.25 mmTotal length - 10, 11.5, 13, 16 mm	Endosseous screw-type implant withinternal morse taper/hex connection.Parallel midsection with double lead threadtapered apically, active apex.Diameter - Ø3.0 mmTotal length - 10, 11.5, 13, 15 mm
Implant DesignDynamic	Endosseous screw-type implant with internalhex connectionParallel coronal and midsection, microthreads on neck, reverse buttress thread inmid-section tapering to an active apex.Diameter - Ø3.0 mmTotal length - 10, 11.5, 13, 16 mm	Endosseous screw-type implant withinternal hex connection.Dynamic - Parallel coronal and midsection,micro threads on neck. Initial "V" shapethread transitioning to reverse buttressthread in mid-section. Tapering apically toa passive apex.Diameter - Ø3.25 mmTotal length - 10, 11.5, 13, 16 mm	Endosseous screw-type implant withinternal morse taper/hex connection.Parallel midsection with double lead threadtapered apically, active apex.Diameter - Ø3.0 mmTotal length - 10, 11.5, 13, 15 mm

The new implant diameter of 3.0 mm is highly similar to the 3.25 mm Predicate and supported by the Nobel Active Reference device implant designs are supported by Predicate device implants. Active apex of the Advanced + and Dynamic implants of the Subject device are additionally supported by the K102436 Reference device. Slight differences to mot affect substantial equivalence nor change the intend use of the devices. The 16 mm implant length is supported by means of the Predicate device and must be placed within the clinical in the Subject device Indications for Use statement. The Subject device has been non-chical bench performance testing.

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DesignParameter	Subject Device	Predicate Device	Reference Device	Reference Device	Reference Device
	Paltop Narrow ImplantPaltop Advanced Dental Solutions	Paltop Narrow Implant (K130462)Paltop Advanced Dental Solutions	NobelActive 3.0 (K102436)Nobel Biocare	Paltop Advanced Dental SolutionsSystem (K112795)Paltop Advanced Dental Solutions	Paltop Dental Sterile Accessories(K131451)Paltop Advanced DentalSolutions
Mode ofOperation	Provide support for prosthetic devices,such as artificial teeth, to restore thepatient's chewing function.	Provide support for prosthetic devices,such as artificial teeth, to restore thepatient's chewing function.	Threaded, root-formdental implants intended foruse in the upper and/or lowerjaw to support prostheticdevices, such as artificialteeth, in order to restorepatient esthetics and chewingfunction to partially or fullyedentulous patients.	Provide support for single andmulti-unit prostheses to restorethe patient's chewing function.	Provide support for prostheticdevices, such as artificial teeth,to restore the patient's chewingfunction.
Implant SurfaceTreatment	Sand-blasted, large grit, Acid-Etched(SLA)	Sand-blasted, large grit, Acid-Etched(SLA)	TiUnite	Sand-blasted, large grit, Acid-Etched (SLA)	n/a
AbutmentSurfaceTreatment	None	None	Unknown	None	n/a
SterilizationMethod of sterilecomponents	Gamma Sterilization	Gamma Sterilization	Unknown	Gamma Sterilization	Gamma Sterilization
SterilizationMethod of non-sterilecomponents	Steam sterilization	Steam sterilization	n/a	Steam sterilization	n/a
Implant/AbutmentInterface	NP Platform Diameter3.0, 3.25 mmInternal interface	NP Platform Diameter3.25 mmInternal interface	3.0 mm Platform Diameter3 mmInternal interface	SP Platform Diameter3.75, 4.2 and 5.0 mmInternal interface	SP Platform Diameter3.75, 4.2 and 5.0 mmInternal interface
	Subject Device	Predicate Device	Reference Device	Reference Device
AbutmentDesign	Paltop Narrow ImplantPaltop Advanced Dental Solutions	Paltop Narrow Implant (K130462)Paltop Advanced Dental Solutions	Paltop Advanced Dental SolutionsSystem (K112795)Paltop Advanced Dental Solutions	Paltop Dental Sterile Accessories(K131451)Paltop Advanced Dental Solutions
	Straight Single-Unit -1, 2, 3, 4 mm GH	Straight Multi-Unit -1, 2, 3 mm GH	Straight Multi-Unit -1, 2, 3 mm GH	Straight Single-Unit -1, 2, 3, 4 mm GH
Straight Single-Unitw/InterfaceCoping	Angulation/Angle Correction0 degreesTop-PortionSingle-Unit Interface CopingSUA Post Height (incl. Top Portion)5.5 mmSUA Prosthetic/Gingival Diameter4.5 mm	Single Straight –1, 2, 3 mm GHAngulation/Angle Correction0 degreesTop-PortionMulti-Unit Ti-AbutmentMUA Post Height (incl. Top Portion)4.5 mmMUA Prosthetic/Gingival Diameter4.5 mm	Single Straight –0, 1, 2, 3 mm GHTop-PortionMulti-Unit Ti-AbutmentMUA Post Height (incl. Top Portion)4.5 mmMUA Prosthetic/Gingival Diameter4.5 mm	Top-PortionSingle-unit CylinderPost Height (incl. Top Portion)10 mmSUA Prosthetic/Gingival Diameter4.5 mm
	Straight Single-Unit -1, 2, 3, 4 mm GH	Straight Multi-Unit -1, 2, 3 mm GH	Straight Multi-Unit -1, 2, 3 mm GH	Straight Single-Unit -1, 2, 3, 4 mm GH
Straight Single-Unitw/TempCylinder	Angulation/Angle Correction0 degreesTop-PortionSingle-Unit CylinderPost Height (incl. Top Portion)5 mm (minimum)SUA Prosthetic/Gingival Diameter4.5 mm	Angulation/Angle Correction0 degreesTop-PortionMulti-Unit Ti-AbutmentMin Post Height (incl. Top Portion)Not specifiedMUA Prosthetic/Gingival Diameter4.5 mm	Top-PortionMulti-Unit Ti-AbutmentMin Post Height (incl. Top Portion)Not specifiedMUA Prosthetic/Gingival Diameter4.5 mm	Top-PortionSingle-Unit CylinderMin Post Height (incl. Top Portion)Not specifiedSUA Prosthetic/Gingival Diameter4.5 mm
	Straight Single-Unit -1, 2, 3, 4 mm GH	Straight Multi-Unit -1, 2, 3 mm GH	Straight Multi-Unit -1, 2, 3 mm GH	Straight Single-Unit -1, 2, 3, 4 mm GH
Straight Single-Unitw/Healing Cap	Angulation/Angle Correction0 degreesTop-PortionHealing Cap for Single UnitSUA Post Height (incl. Top Portion)3.5 mmSUA Prosthetic/Gingival Diameter4.5 mm	Angulation/Angle Correction0 degreesTop-PortionHealing Cap for Multi-UnitPost Height (incl. Top Portion)3.3 mmMUA Prosthetic/Gingival Diameter4.5 mm	Top-PortionHealing Cap for Multi-UnitPost Height (incl. Top Portion)3.3 mmMUA Prosthetic/Gingival Diameter4.5 mm	Top-PortionHealing Cap for Single UnitPost Height (incl. Top Portion)3.3 mmSUA Prosthetic/Gingival Diameter4.5 mm

Mode of Operation, Modified Surfaces, Sterilization, Implant/Abutment Interface

The Mode of Operation, Modified Surfaces, Sterilization Methods and Implant/Abutment interface of the Subject device is the sponsor's Predicate and Reference devices. The "NP" Restorative with both 3.0 and 3.25 Implant Platform Diameters. Recent confirmatory performance testing has been done to validate sterilization methods.

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Straight Single-Unit Abutments

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The Subject device Straight Single-Unit abutments are supported by the Straight Single-Unit abutments in the K131451 Reference device. Furthermor, they combine the features of the Single straight (one part) and Straight Multi-Unit (two-part) abutments, which are both part of the K130462 Predicate and K112795 Reference device, into a single two-part abutment. The use of Interface copings, temporary of two-part abutments are supported by the sponsor's Predicate and encompass similar dimensions.

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Multi-Unit Abutments

AbutmentDesign	Subject DevicePaltop Narrow ImplantPaltop Advanced Dental Solutions	Predicate DevicePaltop Narrow Implant (K130462)Paltop Advanced Dental Solutions	Reference DevicePaltop Advanced Dental SolutionsSystem (K112795)Paltop Advanced Dental Solutions	Reference DevicePaltop Dental Sterile Accessories(K131451)Paltop Advanced Dental Solutions
Straight Multi-Unitw/InterfaceCoping	Straight Multi-Unit -1, 2, 3, 4, 5 mm GHAngulation/Angle Correction0 degreesTop-PortionRetentive Multi-Unit Interface CopingNon-retentive Multi-Unit InterfaceCopingMUA Post Height (incl. Top Portion)4.5, 5.5 mmMUA Prosthetic/Gingival Diameter5 mm	Straight Multi-Unit -1, 2, 3 mm GHAngulation/Angle Correction0 degreesTop-PortionMulti-Unit Ti-AbutmentMUA Post Height (incl. Top Portion)4.5 mmMUA Prosthetic/Gingival Diameter5 mm	n/a	Straight Multi-Unit -1, 2, 3, 4, 5 mm GHTop-PortionMulti-Unit Ti-AbutmentMUA Post Height (incl. Top Portion)10 mmMUA Prosthetic/Gingival Diameter5 mm
Straight Multi-Unitw/TempCylinder	Straight Multi-Unit -1, 2, 3, 4, 5 mm GHAngulation/Angle Correction0 degreesTop-PortionMulti-Unit CylinderMUA Post Height (incl. Top Portion)5 mm (minimum)MUA Prosthetic/Gingival Diameter5 mmDuration of Use	Straight Multi-Unit -1, 2, 3 mm GHAngulation/Angle Correction0 degreesTop-PortionMulti-Unit Ti-AbutmentMUA Post Height (incl. Top Portion)Not specifiedMUA Prosthetic/Gingival Diameter5 mmDuration of UseNot specified	n/a	Straight Multi-Unit -1, 2, 3, 4, 5 mm GHTop-PortionMulti-Unit Ti-AbutmentMUA Post Height (incl. Top Portion)Not specifiedMUA Prosthetic/Gingival Diameter5 mmDuration of UseNot specified
Straight Multi-Unitw/Healing Cap	Straight Multi-Unit -1, 2, 3, 4, 5 mm GHAngulation/Angle Correction0 degreesTop-PortionMulti-Unit Healing CapMulti-Unit Healing Cap, TaperedMUA Post Height (incl. Top Portion)4.5 mmMUA Prosthetic/Gingival Diameter5 mm	Straight Multi-Unit -1, 2, 3 mm GHAngulation/Angle Correction0 degreesTop-PortionHealing Cap for Multi-UnitMUA Post Height (incl. Top Portion)4.5 mmMUA Prosthetic/Gingival Diameter5 mm	n/a	Straight Multi-Unit -1, 2, 3, 4, 5 mm GHTop-PortionHealing Cap for Multi-UnitMUA Post Height (incl. Top Portion)3.3 mmMUA Prosthetic/Gingival Diameter5 mm
17° Multi-Unitw/InterfaceCoping	17° Multi-Unit -3 mm GHMUA Top-PortionRetentive Multi-Unit Interface CopingNon-retentive Multi-Unit InterfaceCopingMUA Post Height (incl. Top Portion)4.5 mmMUA Prosthetic/Gingival Diameter5 mm	n/a	Straight Multi-Unit -1, 2, 3 mm GHAngulated 25° Abutment1, 2, 3 mm GHMUA Top-PortionMulti-Unit Ti-AbutmentMUA Post Height (incl. Top Portion)10 mmMUA Prosthetic/Gingival Diameter5 mm	n/a
17° Multi-Unitw/TempCylinder	17° Multi-Unit3 mm GHMUA Top-PortionMulti-Unit CylinderMin MUA Post Height (incl. TopPortion)5 mmMUA Prosthetic/Gingival Diameter5 mmDuration of Use	n/a	Straight Multi-Unit -1, 2, 3 mm GHAngulated 25° Abutment1, 2, 3 mm GHMUA Top-PortionMulti-Unit Ti-AbutmentMin MUA Post Height (incl. TopPortion)Not specifiedMUA Prosthetic/Gingival Diameter5 mmDuration of UseNot specified	n/a
	17° Multi-Unit3 mm GH		Straight Multi-Unit –1, 2, 3 mm GHAngulated 25° Abutment1, 2, 3 mm GH
17° Multi-Unitw/Healing Cap	MUA Top-PortionMulti-Unit Healing CapMulti-Unit Healing Cap, TaperedMUA Post Height (incl. Top Portion)4.5 mmMUA Prosthetic/Gingival Diameter5 mm	n/a	MUA Top-PortionHealing Cap for Multi-UnitMUA Post Height (incl. Top Portion)3.3 mmMUA Prosthetic/Gingival Diameter5 mm	n/a

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The Subject device Straight Multi-Unit abutments are supported by the Straight Multi-Unit abutments in the K130462 Predicate device. The increased Gingival Height for the straight abutments is supported by the K131451 Reference device and non-clinical performance testing. The temporary cylinder configuration is supported by both the Multi-Unit Ti-Abutment and Gold-Based Abutment of the sponsor's K130462 and K131451 previously cleared devices which can be customized for individual patient occlusion and encompass similar dimensions. Duration of use of temporary cylinders is supported by non-clinical performance testing.

The Subject device 17° Angled Multi-Unit abutments are supported by the combination of the technology of the previously cleared Straight Multi-Unit and the 25° angulated abutments in the K112795 Reference device. The 17° Angulation of the Subject device Multi-unit abutments is also supported by non-clinical performance testing. The temporary cylinder configuration is supported by the sponsor's K112795 Multi-Unit Ti-Abutment is a multi-unit (2-part) abutment accessory which can be customized for individual patient occlusion. Duration of use of temporary cylinders is supported by non-clinical performance testing.

The use of Interface copings, temporary cylinders, and healing caps as part of two-part abutments are supported by the sponsor's Predicate and Reference devices.

Temporary Abutments (direct to implant)
AbutmentDesign	Subject DevicePaltop Narrow ImplantPaltop Advanced Dental Solutions	Predicate DevicePaltop Narrow Implant (K130462)Paltop Advanced Dental Solutions	Reference DeviceNobelActive 3.0 (K102436)Nobel Biocare
Temporary(Engaging,Non-Engaging)	Temporary (Engaging, Non-Engaging)0.5, 2, 3 mm GHPost Height5 mm minimumProsthetic/Gingival Diameter4.25 mmDuration of Use90 days	n/a	Temporary Abutment Engaging1.5m GHPost Height5 mmProsthetic/Gingival DiameterNot definedDuration of UseNot defined*
TemporaryTitaniumImmediate	Temporary Titanium Immediate1.5, 3 mm GHPost Height5 mmProsthetic/Gingival Diameter3.5 mmDuration of Use30 days	n/a	Immediate Temporary Abutment1.5, 3 mm GHPost Height5 mmProsthetic/Gingival DiameterNot definedDuration of UseNot defined*

Temporary Abutments (direct to implant)

*Information not provided in 510(k) Summary document; information obtained from Reference device labeling

The Subject device Temporary Abutments are similar to the K102436 Reference device. Slight differences in gingival height dimension and duration of use are supported by the results of non-clinical performance testing.

The Subject device Temporary Titanium Intermediate abutments are highly similar to the K102436 Reference device and encompass the same gingival height and post height dimensions. Duration of use is supported by the results of non-clinical performance testing.

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AbutmentDesign	Subject Device	Predicate Device	Reference Device
	Paltop Narrow ImplantPaltop Advanced Dental Solutions	Paltop Narrow Implant(K130462)Paltop Advanced DentalSolutions	NobelActive 3.0 (K102436)Nobel Biocare
Straight ball	Straight ball –1, 2, 3 mm GHPost Height2.8 mmProsthetic/Gingival Diameter4 mm	Straight ball –1, 2, 3 mm GHPost Height2.8 mmProsthetic/Gingival Diameter4 mm	n/a
Healing Caps –Integral ThreadConcaveEmergence,StraightEmergence	Healing Caps – Integral ThreadConcave Emergence4, 5, 6, 7 mm GHImage: Healing Cap	Healing Caps – Integral ThreadConcave Emergence1, 2, 3 mm GHImage: Healing Cap	Healing Abutments – IntegralThread3, 5, 7 mm GH
	Prosthetic/GingivalDiameter4 mmStraight Emergence2, 3, 5 mm GHImage: Straight Emergence	Prosthetic/Gingival Diameter4 mm	Prosthetic/Gingival Diameter3.2, 3.8 mmImage: Healing Abutments
	Prosthetic/Gingival Diameter4 mmPost Height1 mm	Post Height1 mm	Post HeightNot specified
Cover Screw	Cover ScrewØ3 mm Implants onlyProsthetic/Gingival Diameter3 mm	Cover ScrewØ3.25 mm Implants onlyProsthetic/Gingival Diameter3.25 mm	Cover ScrewØ3 mm ImplantsProsthetic/Gingival Diameter3 mm

Ball Abutments, Healing Caps, Cover Screws

The Subject device Ball abutments are the K130462 Predicate device Ball abutments.

The Subject Healing Caps are highly similar to the K130462 Predicate device with highly similar gingival height dimensions. The difference in emergence profile of the healing abutments is supported by non-clinical performance testing. The higher gingival height dimensions are supported by the K102436 Reference device.

Minor differences in the implant external thread designs, dimensions, and correction angles do not affect substantial equivalence.

Differences between the Subject and Predicate device dimensions or designs are supported by Reference devices. 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.

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

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The Subject devices have the identical nature of body contact duration, material formulation and sterilization methods compared to the sponsor's 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 <161>.

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.

CONCLUSION

Overall, the Indications for Use statements for the Subject and Predicate devices are substantially equivalent.

Overall, the same or highly similar Technological Characteristics of the Subject device support a finding of substantial equivalence. Any differences between the Subject and Predicate dimensions or designs are supported by Reference devices. Any differences in implant abutment designs or

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dimensions have been mitigated and demonstrated to be suitable for intended use through non-clinical bench performance testing.

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

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.