Who is the manufacturer of Paltop Short Implants?

Paltop Advanced Dental Solutions, Ltd. filed the 510(k) submission for Paltop Short Implants (K232740).

What is the FDA product code for Paltop Short Implants?

DZE. It is classified under 21 CFR 872.3640 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Paltop Short Implants?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Paltop Short Implants?

BioHorizons Tapered Short Implants (K172576).

Who can help prepare an FDA 510(k) submission like Paltop Short Implants?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Paltop Short Implants

K232740 · Paltop Advanced Dental Solutions, Ltd. · DZE · May 22, 2024 · Dental

Device Facts

Record ID	K232740
Device Name	Paltop Short Implants
Applicant	Paltop Advanced Dental Solutions, Ltd.
Product Code	DZE · Dental
Decision Date	May 22, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3640
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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

Device Story

Paltop Short Implants are endosseous root-form dental implants; include cover screws and compatible abutments (Healing Caps, Straight, Temporary, SAS, Straight Ball). Implants are surgically placed in jaw bone by dental professionals to support prosthetic devices for tooth replacement. Inputs: surgical site preparation; device transforms into artificial root structure. Outputs: stable base for prosthetic restoration. Used in dental clinics. Healthcare providers use output to restore patient chewing function. Benefits: restoration of masticatory function in patients requiring dental implants. System includes various diameters (4.2mm-6.0mm) and 6mm lengths. Components fabricated from Titanium-6Aluminum-4Vanadium ELI (ASTM F136). Surface treated with SLA (Sand-blasted, Large Grit, Acid Etched). Provided sterile (gamma irradiation) or non-sterile (steam sterilization).

Clinical Evidence

No clinical data included. Bench testing only. Biocompatibility (ISO 10993-1, ISO 10993-5), endotoxin testing (USP<85>, USP<161>), and MRI safety review performed. Performance testing included pull-out, surface area, and BIC testing. Sterilization and shelf-life data leveraged from reference devices.

Technological Characteristics

Materials: Titanium-6Aluminum-4Vanadium ELI (ASTM F136), PEEK. Surface: SLA (Sand-blasted, Large Grit, Acid Etched). Interface: Internal Hex or Conical. Dimensions: 4.2-6.0mm diameter, 6mm length. Sterilization: Gamma irradiation (sterile components) or steam (non-sterile). Connectivity: N/A (mechanical).

Indications for Use

Indicated for surgical and restorative placement in upper or lower jaw bone as artificial root structure for single tooth replacement or fixed bridgework to support prosthetic devices (artificial teeth) to restore chewing function. Restricted to straight abutments and delayed loading only.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

BioHorizons Tapered Short Implants (K172576)

Reference Devices

MIS Short Implants (K103089)
Bicon Implants with a 2.5mm Internal Connection (K092035)
Paltop Narrow Implant (K210117)
Paltop Conical Implant System (K220200)
Paltop Dental Implant System (K112795)

Related Devices

K212775 — Adin Short Implants · Adin Dental Implants Systems , Ltd. · Jul 8, 2022
K180598 — UNIQA Dental Implants System · Uniqa Dental, Ltd. · Aug 8, 2018
K233163 — ZENEX Implant System_Short · Izenimplant Co., Ltd. · Dec 19, 2023
K171197 — Zuga Dental Implant System · Zuga Medical, Inc. · Jun 30, 2018
K242217 — Surcam Dental Implant System · Surcam Medical Devices and Developments, Ltd. · Jan 29, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. Paltop Advanced Dental Solutions, Ltd Zina Gurgov VP of QA/RA Hashita 5, Industrial Park P.O. Box 3568 Caesarea, 3088900 ISRAEL May 22, 2024 Re: K232740 Trade/Device Name: Paltop Short Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: April 21, 2024 Received: April 22, 2024 Dear Zina Gurgov: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. {2}------------------------------------------------ 3 For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Andrew I. Steen -S Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K232740 Device Name Paltop Short Implants ## Indications for Use (Describe) Paltop Short Implants (Internal Hex and Conical Connections) are in surgical and restorative applications for placement in the bone of the upper or lower jaw as an artificial root structure for single tooth replacement or for fixed bridgework to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Paltop Short Implants are indicated to be used only with straight abutments and are for delayed loading only. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------| | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov *"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."* Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. {4}------------------------------------------------ ## 510(k) Summary K232740 Paltop Advanced Dental Solutions, Ltd. Paltop Short Implants ADMINISTRATIVE INFORMATION | Manufacturer Name | Paltop Advanced Dental Solutions, Ltd Hashita 5, Industrial Park Caesarea 3088900 Israel Telephone: +(972) 4-627-1711 Email: zgurgov@keystonedental.com | |-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Official Contact | Zina Gurgov | | Date Submitted | May 22, 2024 | ## DEVICE NAME AND CLASSIFICATION | Trade/Device Name | Paltop Short Implants | |----------------------|---------------------------------------------------------------------------------------------------| | Common Name | Implant, Endosseous, Root-Form | | Classification Name | Endosseous dental implant | | Regulation Number | 21 CFR 872.3640 | | Regulation Name | Endosseous dental implant | | Regulatory Class | Class II | | Product Code | DZE, NHA | | Classification Panel | Dental Products Panel | | Reviewing Office | Office of Health Technology 1 (OHT1: Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices) | | Reviewing Division | Division of Health Technology 1 B (Dental and ENT Devices) | ## PREDICATE DEVICE INFORMATION The Subject device is substantially equivalent in Indications for Use, and technological/design principles to the following legally marketed primary predicate device: | 510(k) | Primary Predicate Device Name | Company Name | |---------|------------------------------------|----------------------------------| | K172576 | BioHorizons Tapered Short Implants | BioHorizons Implant System, Inc. | Reference devices were leveraged for technology, material, implant connections, sterility, and design principles. {5}------------------------------------------------ | 510(k) | Reference Predicate Device Name | Company Name | |---------|-------------------------------------------------|---------------------------------------| | K103089 | MIS Short Implants | MIS Implants Technologies Ltd. | | K092035 | Bicon Implants with a 2.5mm Internal Connection | Bicon, LLC | | K210117 | Paltop Narrow Implant | Paltop Advanced Dental Solutions Ltd. | | K220200 | Paltop Conical Implant System | Paltop Advanced Dental Solutions Ltd. | | K112795 | Paltop Dental Implant System | Paltop Advanced Dental Solutions Ltd. | ## DEVICE DESCRIPTION The purpose of this submission is for the marketing clearance for the Paltop Short Implants which comprises endosseous root-form dental implants, cover screw, and compatible abutments. The Subject device abutments are compatible with prior cleared implant bodies, and abutments from prior clearances are compatible with new Subject device implant bodies. Subject device abutments are also compatible with previously cleared implant bodies in K112795. Subject device are compatible with straight abutments previously cleared in K112795, K131451, K220200, and K221381. Endosseous dental implants are surgically implanted into a patient's mouth to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Endosseous dental implant abutments are secured to dental implants with a retaining screw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Paltop Short Implant System includes endosseous screw type dental implant bodies, which can be used in twostage surgeries with associated compatible abutments. The Subject device abutments provide a range of cementretained and screw-retained prosthetic solutions for dental implant restoration. Paltop Short Implant System includes six compatible implant abutment designs: Healing Caps, Straight, Temporary, Snap-On Abutment System (SAS) Abutment, and Straight Ball Abutment. The implant bodies, titanium abutments and cover screw are fabricated from a Titanium 4 Vanadium ELI titanium alloy (Grade 23) which conforms to ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium EU (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The Subject device implant bodies are surface treated with SLA (Sand-blasted, Large Grit, Acid Etched). The Snap On Abutment System(SAS) Abutments are supplied sterile with a PEEK cap. All implants and prosthetic components are one-time use device components are provided sterile and sterilized by gamma irradiation except for the replacement cover screws which are provided nonsterile. Devices provided as non-sterile are sterilized by steam. {6}------------------------------------------------ | Paltop Short Implants - Implant Sizes | | | | | |---------------------------------------|---------------------------------|------------------------|--------------------------------|--------------| | Implant Type | Prosthetic Interface Connection | Implant Diameters (mm) | Implant Platform Diameter (mm) | Lengths (mm) | | Advanced | Internal Hex | Ø 4.2 | Ø 3.65 | 6 | | | | Ø 5.0 | Ø 3.65 | 6 | | | | Ø 6.0 | Ø 4.4 | 6 | | Advanced + | Internal Hex | Ø 4.2 | Ø 3.65 | 6 | | | | Ø 5.0 | Ø 3.65 | 6 | | | | Ø 6.0 | Ø 4.4 | 6 | | Dynamic | Internal Hex | Ø 4.2 | Ø 3.65 | 6 | | | | Ø 5.0 | Ø 3.65 | 6 | | | | Ø 6.0 | Ø 4.4 | 6 | | Dynamic Conical | Conical Connection | Ø 4.2 | Ø 2.9 | 6 | | | | Ø 5.0 | Ø 2.9 | 6 | | Dynamic Conical MC | Conical Connection | Ø 4.2 | Ø 2.9 | 6 | | | | Ø 5.0 | Ø 2.9 | 6 | | PCA | Conical Connection | Ø 4.2 | Ø 2.9 | 6 | | | | Ø 5.0 | Ø 2.9 | 6 | | PAI | Internal Hex | Ø 4.2 | Ø 3.65 | 6 | | | | Ø 5.0 | Ø 3.65 | 6 | | | | Ø 6.0 | Ø 4.4 | 6 | | PAI TC | Internal Hex | Ø 4.2 | Ø 3.65 | 6 | | | | Ø 5.0 | Ø 3.65 | 6 | | | | Ø 6.0 | Ø 4.4 | 6 | # Paltop Short Implants – Abutment Types | | | Subject Device Abutment Designs | | | | | |---------------------|-----------------------|-------------------------------------|-----------------------------|-------------------------------|-------------------|---------------------------------------| | Connection Platform | Implant Diameter (mm) | Healing Caps Image: Healing Caps | Straight Image: Straight | Temporary Image: Temporary | SAS Image: SAS | Straight Ball Image: Straight Ball | | Internal Hex SP | 4.2 | X | Not included | X | X | X | | Internal Hex SP | 5.0 | X | Not included | X | X | X | | Internal Hex WP | 6.0 | X | X | X | X | Not included | | | Indexed/Non-Indexed | Non- indexed | Indexed | Indexed, Non-Indexed | Indexed | Non- indexed | | Material | | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | | Finish | | WP- Purple Anodize SP- None | None | None | None | None | {7}------------------------------------------------ ## INDICATIONS FOR USE Paltop Short Implants (Internal Hex and Connections) are indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw as an artificial root structure for single tooth replacement or for fixed bridgework to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Paltop Short Implants are indicated to be used only with straight abutments and are for delayed loading only. ## EQUIVALENCE TO MARKETED DEVICE The Subject device is highly similar to the Predicate device with respect to Indications for Use and technological principles. The Comparison tables below compare the Indications for Use and Technological Characteristics of the Subject and Predicate/Reference devices. | | Indications for Use Comparison Table | |---------------------------------|--------------------------------------------------------------------------------------------------------------| | Device | Indications for Use Statement | | Subject Device | Paltop Short Implants (Internal Hex and Conical Connections) are indicated for use in surgical and | | Paltop Short Implants | restorative applications for placement in the bone of the upper or lower jaw as an artificial root structure | | | for single tooth replacement or for fixed bridgework to provide support for prosthetic devices, such as | | Paltop Advanced | artificial teeth, in order to restore the patient's chewing function. Paltop Short Implants are indicated to | | Dental Solutions Ltd. | be used only with straight abutments and are for delayed loading only. | | | BioHorizons Tapered Short Implants are intended for use in the mandible or maxilla as an artificial root | | Primary Predicate Device | structure for single tooth replacement or for fixed bridgework and dental retention. The implants may be | | BioHorizons Tapered Short | restored using delayed loading, or with a terminal or intermediate abutment for fixed or removable | | Implants | bridgework, and for overdentures. | | (K172576) | | | | | | BioHorizons Implant System, Inc | | | Reference Device | MIS dental implants are intended to be surgically placed in the bone of the upper or lower jaw arches to | | MIS Short Implants | provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing | | (K103089) | function. | | | | | MIS Implants Technologies Ltd. | When a one stage surgical procedure is applied, the implant may be immediately loaded when good | | | primary stability is achieved and the occlusal load is appropriate. | | | | | | MIS short implants are to be used only with straight abutments. | | Reference Device | The Bicon implant is designed for use in edentulous sites in the mandible or maxilla for support of a | | Bicon Implants with a 2.5mm | complete denture prosthesis, a final or intermediate abutment for fixed bridgework or for partial | | Internal Connection | dentures, or as a single tooth replacement. | | (K092035) | | | | | | Bicon, LLC | | | Reference Device | The Paltop Conical Implant System is indicated for use in surgical and restorative applications for | | Paltop Conical Implant System | placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as | | (K220200) | artificial teeth, in order to restore the patient's chewing function. Narrow diameter implants are intended | | | for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially | | Paltop Advanced | edentulous jaws where the horizontal space is limited by the adjacent teeth and roots. The Paltop Conical | | Dental Solutions Ltd. | Implant System is also indicated for immediate loading when good primary stability is achieved and with | | | appropriate occlusal loading. | | Reference Device | The Paltop Narrow Implant is indicated for use in surgical and restorative applications for placement in | | Paltop Narrow Implant | the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws | | (K210117) | where the horizontal space is limited by the adjacent teeth and roots, to provide support for prosthetic | | | devices, such as artificial teeth, in order to restore the patient's chewing function. The Paltop Narrow | | Paltop Advanced | Implant is indicated also for immediate loading when good primary stability is achieved and with | | Dental Solutions Ltd. | appropriate occlusal loading. | #### Comparison of Indications for Use Statements {8}------------------------------------------------ | Indications for Use Comparison Table | | |-----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device | Indications for Use Statement | | Reference Device Paltop Advanced Dental Solutions System (K112795) Paltop Advanced Dental Solutions Ltd. | The Paltop Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Paltop Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. | The Subject and primary Predicate devices have highly similar Indications for Use, differing primarily in device name and grammar. The primary Predicate device is indicated for use as an 'artificial root structure for single tooth replacement or for fixed bridgework and dental retention', while the Subject device does not indicate for 'dental retention'. The primary Predicate device is indicated for use for to be 'restored using , or with a terminal or intermediate abutment for fixed or removable bridgework, and for overdentures', whereas the Subject device is indicated for 'delayed loading'. The indications are expressed highly similarly using different wording, such as the addition of 'to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function' in the Subject device's IFUS. The Indications for Use of the Subject device indicates that the Paltop Short Implants are only to be used with straight abutments, which is more limited than the primary predicate device. {9}------------------------------------------------ #### Paltop Short Implants | Comparison of Technological Characteristics | | | | | | | | |---------------------------------------------|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------| | Design Parameter | Subject Device Paltop Short Implants Paltop Advanced Dental Solutions Ltd. | Primary Predicate Device BioHorizons Tapered Short Implants (K172576) BioHorizons Implant System, Inc. | Reference Device MIS Short Implants (K103089) MIS Implants Technologies Ltd. | Reference Device Bicon Implants with a 2.5mm Internal Connection (K092035) Bicon, L.L.C. | Reference Device Paltop Conical Implant System (K220200) Paltop Advanced Dental Solutions Ltd. | Reference Device Paltop Narrow Implant (K210117) Paltop Advanced Dental Solutions Ltd. | Reference Device Paltop Advanced Dental Solutions System (K112795) Paltop Advanced Dental Solutions Ltd. | | Regulation # | 21 CFR 872.3640 | 21 CFR 872.3640 | 21 CFR 872.3640 | 21 CFR 872.3640 | 21 CFR 872.3640 | 21 CFR 872.3640 | 21 CFR 872.3640 | | Product Code | DZE, NHA | DZE | DZE | DZE, NHA | DZE, NHA | DZE, NHA | DZE, NHA | | Classification | Class II | Class II | Class II | Class II | Class II | Class II | Class II | | Materials | Implants/Screws - Titanium Ti-6Al- 4V ELI Abutments- Titanium Ti-6Al- 4V ELI, PEEK | Titanium Ti-6Al- 4V | Titanium Ti-6Al- 4V ELI | Titanium Ti-6Al-4V | Implants/Screws - Titanium Ti-6Al-4V ELI Abutments- Titanium Ti-6Al-4V ELI, PEEK | Implants/Screws - Titanium Ti-6Al-4V ELI Abutments- Titanium Ti-6Al-4V ELI | Implants/Screws - Titanium Ti-6Al-4V ELI Abutments- Titanium Ti-6Al-4V ELI | | Reason for Predicate/ Reference | Not Applicable | • Indications for Use • Implant diameters • Implant length • Material | • Implant diameters • Implant length • Machined neck | • Implant diameters • Implant length • Material • Implant neck design - non- threaded surface neck | • Implant Design • Implant/ Abutment Interface • Abutment Design • Implant Modified Surface • Material • Biocompatibility • Sterilization • Labeling | • Implant Design • Implant/ Abutment Interface • Abutment Design • Implant Modified Surface • Material • Biocompatibility • Sterilization • Labeling | • Implant Design • Implant/Abutment Interface • Abutment Design | ## Comparison of Technological Characteristics {10}------------------------------------------------ | Implant Design | | | | | | | | |-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------| | | Technological Characteristics Comparison Table – Implant Design | | | | | | | | Design Parameter | Subject Device Paltop Short Implants Paltop Advanced Dental Solutions Ltd. | Primary Predicate Device BioHorizons Tapered Short Implants (K172576) BioHorizons Implant System, Inc. | Reference Device MIS Short Implants (K103089) MIS Implants Technologies Ltd. | Reference Device Bicon Implants with a 2.5mm Internal Connection (K092035) BICON, LLC | Reference Device Paltop Conical Implant System (K220200) Paltop Advanced Dental Solutions Ltd. | Reference Device Paltop Narrow Implant (K210117) Paltop Advanced Dental Solutions Ltd. | Reference Device Paltop Advanced Dental Solutions System (K112795) Paltop Advanced Dental Solutions Ltd. | | Implant Descriptio n | Advanced the following: Here is the JSON requested: ```json { | | | | | | | | Design Parameter | Subject Device Paltop Short Implants Paltop Advanced Dental Solutions Ltd. | Primary Predicate Device BioHorizons Tapered Short Implants (K172576) BioHorizons Implant System, Inc. | Reference Device MIS Short Implants (K103089) MIS Implants Technologies Ltd. | Reference Device Bicon Implants with a 2.5mm Internal Connection (K092035) BICON, LLC | Reference Device Paltop Conical Implant System (K220200) Paltop Advanced Dental Solutions Ltd. | Reference Device Paltop Narrow Implant (K210117) Paltop Advanced Dental Solutions Ltd. | Reference Device Paltop Advanced Dental Solutions System (K112795) Paltop Advanced Dental Solutions Ltd. | | | connection. Parallel coronal and midsection, micro threads on neck, reverse buttress thread in mid-section tapering to an active/cutting apex. Platform switching taper on implant top level. Dynamic Conical- Endosseous screw- type implant with internal connection. Parallel coronal and midsection, micro threads on neck, reverse buttress thread in mid-section tapering to an active/cutting apex. Platform switching taper on implant top level. Dynamic Conical MC- Endosseous screw-type implant with internal connection. Parallel coronal and midsection, 0.8mm machined | | | | | | | | Technological Characteristics Comparison Table - Implant Design | | | | | | | | | Design Parameter | Subject Device Paltop Short Implants Paltop Advanced Dental Solutions Ltd. | Primary Predicate Device BioHorizons Tapered Short Implants (K172576) BioHorizons Implant System, Inc. | Reference Device MIS Short Implants (K103089) MIS Implants Technologies Ltd. | Reference Device Bicon Implants with a 2.5mm Internal Connection (K092035) BICON, LLC | Reference Device Paltop Conical Implant System (K220200) Paltop Advanced Dental Solutions Ltd. | Reference Device Paltop Narrow Implant (K210117) Paltop Advanced Dental Solutions Ltd. | Reference Device Paltop Advanced Dental Solutions System (K112795) Paltop Advanced Dental Solutions Ltd. | | | buttress thread in mid-section tapering to an active/cutting apex. Platform switching taper on implant top level. PCA- Endosseous screw-type implant with internal connection. Parallel coronal and midsection, micro threads on neck, double leaded "V" shape progressive thread, tapered apically, active apex. Platform switching taper on implant top level. | | | | | | | | | PAI - Endosseous screw-type implant with internal hex connection. Machined neck. Parallel midsection with double lead thread, tapered apically with active apex. Platform switching taper on implant top level. | | | | | | | | | PAI TC - Endosseous screw- | | | | | | | {11}------------------------------------------------ _Traditional 510(k) Submission {12}------------------------------------------------ _Traditional 510(k) Submission {13}------------------------------------------------ Traditional 510(k) Submission | | | | Technological Characteristics Comparison Table - Implant Design | | | | | | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|--|--| | Design Parameter | Subject Device Paltop Short Implants Paltop Advanced Dental Solutions Ltd. | Primary Predicate Device BioHorizons Tapered Short Implants (K172576) BioHorizons Implant System, Inc. | Reference Device MIS Short Implants (K103089) MIS Implants Technologies Ltd. | Reference Device Bicon Implants with a 2.5mm Internal Connection (K092035) BICON, LLC | Reference Device Paltop Conical Implant System (K220200) Paltop Advanced Dental Solutions Ltd. | Reference Device Paltop Narrow Implant (K210117) Paltop Advanced Dental Solutions Ltd. | Reference Device Paltop Advanced Dental Solutions System (K112795) Paltop Advanced Dental Solutions Ltd. | | | | | type implant with internal hex connection. Machined Neck. Implant surface treatment extending to the implant top level. Parallel midsection with double lead thread, tapered apically with active apex. Platform switching taper on implant top level. | | | | | | | | | | Implant Dimensions D = Implant Body Diameter (mm) IP = Implant Platform Diameter (mm) L = Implant Length (mm) NP = Not provided | D IP L 4.2 3.65 6.0 5.0 3.65 6.0 6.0 4.4 6.0 | D IP L 4.6 NP 6.0, 7.5 5.8 NP 6.0, 7.5 | D IP L 4.2 NP 6.0 5.0 NP 6.0 6.0 NP 6.0 | D IP L 4.0 2.5 5.0 4.0 2.5 6.0 4.0 2.5 8.0 4.0 2.5 11.0 | D IP L 3.25 2.9 10, 11.5, 13, 16 3.75 2.9 8, 10, 11.5, 13, 16 4.2 2.9 8, 10, 11.5, 13, 16 5.0 2.9 8, 10, 11.5, 13, 16 | D IP L 3.0 2.9 10, 11.5, 13, 16 | D IP L 3.75 3.65 8, 10, 11.5, 13, 16 4.2 3.65 8, 10, 11.5, 13, 16 5.0 3.65 8, 10, 11.5, 13, 16 | | | | Mode of Operation | Provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. | An artificial root structure for single tooth replacement or for fixed bridgework and dental retention. The implants may be restored using delayed loading, or with a terminal or | Not provided | The Bicon implant is designed for use in edentulous sites in the mandible or maxilla for support of a complete denture prosthesis, a final or intermediate abutment for fixed bridgework or for partial | Provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. | Provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. | Provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. | | | {14}------------------------------------------------ Traditional 510(k) Submission | | Technological Characteristics Comparison Table - Implant Design | | | | | |…