J & P Click Attachments are designed to support fixed, partial or full arch restorations on endosseous dental implants in the mandible or maxilla for the purpose of restoring masticatory function. They are used in fixed hybrid restorations that can be attached with a click in system. Click attachments are indicated for use with vertical implant placements. They are indicated for the following implant systems: Biohorizons Tapered Tissue Level implants in diameters 3.8, 4.2, 4.6, 5.2 mm Nobel Biocare NobelActive including 3.5. 4.3, 5.0 mm diameter NobelActive, 3.75, 4.3, 5.0mm diameter NobelParallel and 3.5. 4.3. 5.0mm diameter NobelReplace Conical Connection Implants Implant Direct Legacy 3 for 3.7, 4.2, 4.7, 5.2mm diameter implants Surgikor Versatile for 3.5, 3.75, 4.2, 4.5, 5.0, 6.0mm diameter implants Surgikor Fixation for 3.5. 3.9. 4.3. 5.0mm diameter implants Surgikor Solution for 3.5, 4.0, 4.5, 5.0, 5.5, 6.0mm diameter implants Neodent Grand Morse for 3.5, 3.75, 4.0, 4.3 and 5.0 mm diameter implants MIS Seven for implant diameters 3.75, 4.2, 5, and 6mm Zimmer for Tapered Screw-Vent in 3.7, 4.1 and 4.7mm implant diameter Hiossen ETIII for 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, and 7.0mm implant diameters SIN Cone Morse 11.5° and 16° implant lines 11.5° Strong SW/SW Plus implant diameters 3.5. 3.8.4.5. 5.0mm Unitite implant diameters 3.5. 4.0.4.3. 5.0. 6.0 Tryon CM Conical implant diameters 3.5, 4.5, 5.0 Tryon CM Cylindrical implant diameters 3.5, 3.75, 4.0. 5.0 Epikut CM/CM Plus implant diameters 3.5, 3.8, 4.0. 4.5, 5.0 16 ° Strong SW CM Plus implant diameters 3.5, 3.8, 4.5 and 5.0mm Epikut S/S Plus implant diameters 3.5, 3.8. 4.0. 4.5. 5.0mm

Device Description

J & P Click Attachments provide a rigid connection of fixed, partial and full arch restorations (fixed/detachable hybrid dentures) to endosseous dental implants. They consist of abutments, attachment housings, and inserts. The abutments are provided in various OEM implant and abutment connections. The abutments are made from Ti-6AL-4V ELI which meets ASTM F136. All varieties of click attachments come in collar heights of 1, 2, 3, 4, 5 and 6mm. Abutment platform diameters include: Biohorizons 3.5, and 4.5mm Nobel Biocare Nobel Active 3.5 and 3.9mm (NobelParallel and NobelReplace Conical Connection are the same) Implant Direct Legacy 3.5 and 4.5mm Surgikor Versatile 3.5 and 4.5mm Surgikor Fixation and Solution 3.5 and 3.9mm Neodent Grand Morse 3.0mm MIS Seven 3.5 and 4.5mm Zimmer for Tapered ScrewVent 3.5 and 4.5mm Hiossen ETIII 3.35mm SIN 2.5mm for 11.5° cone morse and 2.72 mm for 16° cone morse

AI/ML Overview

The document describes the J & P Click Attachments, which are dental implant abutments. The submission aims to demonstrate substantial equivalence to a predicate device, the Zest High Retention Attachment System (K220252), and several reference predicates.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

It is important to note that the provided text is a 510(k) summary for a premarket notification, which focuses on demonstrating substantial equivalence to a predicate device, rather than defining specific acceptance criteria for a new clinical study. Therefore, the "acceptance criteria" here are based on comparative attributes for demonstrating substantial equivalence, and "reported device performance" refers to the characteristics of the J & P Click Attachments as compared to the predicate.

Acceptance Criteria (Comparative Attribute for Substantial Equivalence)	J & P Click Attachments (Reported Device Performance)	Predicate Device (Zest High Retention Attachments K220252)
Indications for Use	Designed to support fixed, partial or full arch restorations on endosseous dental implants in the mandible or maxilla for restoring masticatory function. Used in fixed hybrid restorations that can be attached with a click in system. Indicated for use with vertical implant placements.	Designed to support fixed, partial or full arch restorations on endosseous dental implants in the mandible or maxilla for restoring masticatory function. Used in fixed hybrid restorations that can be attached with a snap-in system. (The subject device's vertical implant placement restriction is a subset of the predicate's indications).
Material	Ti6Al4V (meets ASTM F136)	Ti6Al4V
Mechanism of Action	Used with various dental implant systems to make fixed hybrid restorations.	Used with various dental implant systems to make fixed hybrid restorations.
Sterilization	Provided non-sterile with instructions for user to sterilize them.	Provided non-sterile with instructions for user to sterilize them.
Compatible Implant Systems	Biohorizons Tapered Tissue Level (3.8, 4.2, 4.6, 5.2 mm), Nobel Biocare (NobelActive 3.5, 4.3, 5.0 mm; NobelParallel 3.75, 4.3, 5.0 mm; NobelReplace Conical Connection 3.5, 4.3, 5.0 mm), Implant Direct Legacy 3 (3.7, 4.2, 4.7, 5.2 mm), Surgikor Versatile (3.5, 3.75, 4.2, 4.5, 5.0, 6.0 mm), Surgikor Fixation (3.5, 3.9, 4.3, 5.0 mm), Surgikor Solution (3.5, 4.0, 4.5, 5.0, 5.5, 6.0 mm), Neodent Grand Morse (3.5, 3.75, 4.0, 4.3, 5.0 mm), MIS Seven (3.75, 4.2, 5, 6 mm), Zimmer Tapered Screw-Vent (3.7, 4.1, 4.7 mm), Hiossen ETIII (3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 mm), SIN Cone Morse 11.5° and 16° lines (various diameters listed).	Nobel Active (3.5, 4.3, 5.5 mm), Biohorizons Tapered Tissue Level (3.8, 4.6 mm), Implant Direct Legacy 3 (3.7, 4.2, 4.7, 5.2, 5.7 mm), Neodent Grand Morse (3.5, 3.75, 4.0, 4.3, 5.0 mm), MIS Seven (3.75, 4.2, 5.0, 6.0 mm), Zimmer Tapered Screw-Vent (3.7, 4.1, 4.7, 6.00 mm), Hiossen ET III (3.5, 4.0, 4.5, 5.0, 6.0, 7.0 mm).
Abutment Platform Diameters / Gingival Heights	Varies by implant system, e.g., Biohorizons 3.5, 4.5mm; Nobel Biocare 3.5, 3.9mm; various gingival heights (1, 2, 3, 4, 5, 6mm).	Varies by implant system, e.g., Neodent GM Interface (1,2,3,4,5,6mm), Hiossen ETIII (1,2,3,4,5,6mm), Biohorizons Tapered Pro 3.5 Interface (0, 1, 2.5, 3.5, 4.5, 5.5, 6.5mm), Biohorizons Tapered Pro Wide Interface (0,1,2,3,4,5,6mm).
Attachment Design	"Very similar" to predicate, with "slight differences in the dimensions."	Similar to subject device.

Study Proving Device Meets Acceptance Criteria:

The document describes a series of non-clinical tests and a comparison to predicate devices, rather than a single "study that proves the device meets acceptance criteria" in the sense of a clinical trial with predefined statistical endpoints. The primary method for demonstrating substantial equivalence is through comparative analysis with predicate devices and non-clinical testing.

Non-Clinical Testing Performed:

Abutment Steam Sterilization: Done according to ISO 17665-1.
Cytotoxicity Testing: Conducted according to ISO 10993-5.
Reverse Engineering Tolerance Analyses: Conducted for all OEM implant systems in the indications for use. These analyses covered OEM implant body models, OEM abutment models, and OEM abutment screw models to ensure compatibility.
MR Environment Condition (MRI Review): Non-clinical worst-case MRI review was performed using scientific rationale and published literature (e.g., Woods, Terry O., et al., 2019) to evaluate magnetic compatibility, specifically for magnetically induced displacement force and torque, based on the entire system and material composition (Ti-6AL-4V ELI).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe a clinical "test set" with human or animal subjects in the traditional sense of a clinical study.
The "test set" for the reverse engineering tolerance analyses would be the designs and physical specifications of the OEM implant systems. The number of samples for these analyses is not specified beyond "all OEM implant systems in the indications for use."
Data provenance: Not explicitly stated, but the submission is for an FDA 510(k), implying compliance with US regulatory standards. Non-clinical tests like cytotoxicity (ISO 10993-5) and sterilization (ISO 17665-1) are international standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The substantial equivalence determination is based on comparative attributes and non-clinical engineering and biological testing, not on expert-adjudicated ground truth from a clinical data set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as there is no mention of a human-reviewed "test set" requiring adjudication in the context of this 510(k) submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided and is not applicable to this type of medical device (dental implant attachments). MRMC studies are typically used for imaging diagnostics involving human readers and AI. This device is a mechanical component, not an AI software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not provided and is not applicable. This device is a physical dental component and does not involve an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests:
- Sterilization: Ground truth is defined by the requirements of ISO 17665-1.
- Cytotoxicity: Ground truth is defined by the requirements and endpoints of ISO 10993-5.
- Reverse Engineering Tolerance Analyses: Ground truth is the design specifications and tolerances of the referenced OEM implant systems.
- MRI Environment Review: Ground truth is established by scientific rationale and published literature referenced (e.g., relating to magnetic properties of materials).
For substantial equivalence: The "ground truth" is the established characteristics and performance of the legally marketed predicate devices, as documented in their 510(k) clearances and product specifications.

8. The sample size for the training set

This information is not provided and is not applicable. The device is a physical medical device, not an AI or software device that undergoes a training phase.

9. How the ground truth for the training set was established

This information is not provided and is not applicable (see point 8).

Summary

{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.

J & P Dental Technologies c/o Angela Blackwell Senior Consultant Blackwell Device Consulting P.O. Box 718 Gresham, Oregon 97030-0172

March 26, 2024

Re: K231132

Trade/Device Name: J & P Click Attachments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: February 27, 2024 Received: February 28, 2024

Dear Angela Blackwell:

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}------------------------------------------------

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}------------------------------------------------

For comprehensive regulatory information about mediation-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}------------------------------------------------

Indications for Use

510(k) Number (if known) K231132

Device Name J & P Click Attachments

Indications for Use (Describe) J & P Click Attachments are designed to support fixed, partial or full arch restorations on endosseous dental implants in the mandible or maxilla for the purpose of restoring masticatory function. They are used in fixed hybrid restorations that can be attached with a click in system. Click attachments are indicated for use with vertical implant placements. They are indicated for the following implant systems: Biohorizons Tapered Tissue Level implants in diameters 3.8, 4.2, 4.6, 5.2 mm Nobel Biocare NobelActive including 3.5. 4.3, 5.0 mm diameter NobelActive, 3.75, 4.3, 5.0mm diameter NobelParallel and 3.5. 4.3. 5.0mm diameter NobelReplace Conical Connection Implants Implant Direct Legacy 3 for 3.7, 4.2, 4.7, 5.2mm diameter implants Surgikor Versatile for 3.5, 3.75, 4.2, 4.5, 5.0, 6.0mm diameter implants Surgikor Fixation for 3.5. 3.9. 4.3. 5.0mm diameter implants Surgikor Solution for 3.5, 4.0, 4.5, 5.0, 5.5, 6.0mm diameter implants Neodent Grand Morse for 3.5, 3.75, 4.0, 4.3 and 5.0 mm diameter implants MIS Seven for implant diameters 3.75, 4.2, 5, and 6mm Zimmer for Tapered Screw-Vent in 3.7, 4.1 and 4.7mm implant diameter Hiossen ETIII for 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, and 7.0mm implant diameters

SIN Cone Morse 11.5° and 16° implant lines

11.5° Strong SW/SW Plus implant diameters 3.5. 3.8.4.5. 5.0mm Unitite implant diameters 3.5. 4.0.4.3. 5.0. 6.0 Tryon CM Conical implant diameters 3.5, 4.5, 5.0 Tryon CM Cylindrical implant diameters 3.5, 3.75, 4.0. 5.0 Epikut CM/CM Plus implant diameters 3.5, 3.8, 4.0. 4.5, 5.0

16 ° Strong SW CM Plus implant diameters 3.5, 3.8, 4.5 and 5.0mm Epikut S/S Plus implant diameters 3.5, 3.8. 4.0. 4.5. 5.0mm

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."

{4}------------------------------------------------

510k Summary K231132 March 25, 2024 J & P Click Attachments

Name and address: J & P Dental Technologies 1527 W State Hwy 114 Ste 500-280 Grapevine, TX 76051 Contact Person: Dr. Aaron Paz Phone Number: (310) 877-9858 Name of device: J & P Click Attachments Classification Name: Endosseous dental implant abutments CFR: 21 CFR 872.3630 Primary Product Code: NHA Primary Predicate Device: Zest Anchors K220252 High Retention Attachment System Reference Predicates: Nobel Active K142260 Allied Dental Solutions K152845 Implant Direct K192221 Legacy 3 and Interactive SIN K221453 Epikut CM and K222231 Epikut S MIS K040807 Seven Biohorizons K071638 Tapered Tissue Level implant Neodent K203382 Neodent GM Implants Zimmer K160398 Tapered Screw Vent Hiossen K140934 ET III Surgikor K182615 Surgikor Dental Implant System

Submission Contact:

Angela Blackwell Blackwell Device Consulting P.O. Box 718 Gresham, OR 97030-0172 (704)450-9934 angela@blackwelldevice.com

Device Description: J & P Click Attachments provide a rigid connection of fixed, partial and full arch restorations (fixed/detachable hybrid dentures) to endosseous dental implants. They consist of abutments, attachment housings, and inserts. The abutments are provided in various OEM implant and abutment connections. The abutments are made from Ti-6AL-4V ELI which meets ASTM F136. All varieties of click attachments come in collar heights of 1, 2, 3, 4, 5 and 6mm. Abutment platform diameters include:

Biohorizons 3.5, and 4.5mm

{5}------------------------------------------------

Nobel Biocare Nobel Active 3.5 and 3.9mm (NobelParallel and NobelReplace Conical Connection are the same) Implant Direct Legacy 3.5 and 4.5mm Surgikor Versatile 3.5 and 4.5mm Surgikor Fixation and Solution 3.5 and 3.9mm Neodent Grand Morse 3.0mm MIS Seven 3.5 and 4.5mm Zimmer for Tapered ScrewVent 3.5 and 4.5mm Hiossen ETIII 3.35mm SIN 2.5mm for 11.5° cone morse and 2.72 mm for 16° cone morse

Indications for Use:

They are indicated for the following implant systems:

Biohorizons Tapered Tissue Level implants in diameters 3.8, 4.2, 4.6, 5.2 mm

Nobel Biocare NobelActive including 3.5, 4.3, 5.0 mm diameter NobelActive,3.75, 4.3, 5.0mm diameter NobelParallel and 3.5, 4.3, 5.0mm diameter NobelReplace Conical Connection Implants

lmplant Direct Legacy 3 for 3.7, 4.2, 4.7, 5.2mm diameter implants

Surgikor Versatile for 3.5, 3.75, 4.2, 4.5, 5.0, 6.0mm diameter implants

Surgikor Fixation for 3.5, 3.9, 4.3, 5.0mm diameter implants

Surgikor Solution for 3.5, 4.0, 4.5, 5.0, 5.5, 6.0mm diameter implants

Neodent Grand Morse for 3.5, 3.75, 4.0, 4.3 and 5.0 mm diameter implants

MIS Seven for implant diameters 3.75, 4.2, 5, and 6mm

Zimmer for Tapered Screw-Vent in 3.7, 4.1 and 4.7mm implant diameter

Hiossen ETIII for 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, and 7.0 mm implant diameters

SIN Cone Morse 11.5° and 16° implant lines

11.5° Strong SW/SW Plus implant diameters 3.5, 3.8, 4.5, 5.0mm Unitite implant diameters 3.5, 4.0,4.3, 5.0, 6.0 Tryon CM Conical implant diameters 3.5, 4.5, 5.0 Tryon CM Cylindrical implant diameters 3.5, 3.75, 4.0, 5.0 Epikut CM/CM Plus implant diameters 3.5, 3.8, 4.0, 4.5, 5.0

{6}------------------------------------------------

16 ° Strong SW CM/CM Plus implant diameters 3.5, 3.8, 4.5 and 5.0mm Epikut S/S Plus implant diameters 3.5, 3.8, 4.0, 4.5, 5.0mm

Testing Summary: Abutment steam sterilization was done according to ISO 17665-1. Cytotoxicity testing was conducted according to ISO 10993-5. Reverse engineering tolerance analyses were conducted for all OEM implant systems in the indications for use. These analyses covered the entire OEM implant system and included OEM implant body models, OEM abutment models and OEM abutment screw models.

MR Environment Condition

Non-clinical worst-case MRI review was performed to evaluate the metallic J & P Click Attachment devices 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, dental 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.

Substantial Equivalence:

Click attachments are substantially equivalent to Zest High Retention Attachments abutments in
indications for use, materials, design, and implant system compatibility.
Abutment Comparison	L&P Click Attachments	Zest High Retention Attachments
Abutment ComparisonTable	J & P Click Attachments	Zest High Retention AttachmentsK220252
Sterilization ofabutments	Provided non-sterile withinstructions for user to sterilizethem	Provided non-sterile with instructionsfor user to sterilize them
Abutments availablefor these implantsystems	Nobel Active implant diameters3.5, 4.3, and 5.00mmNobelParallel implant diameters3.75, 4.3, and 5.0mmNobelReplace implant diameters3.5, 4.3 and 5.0mmBiohorizons Tapered Tissue Levelimplant diameters 3.8, 4.6mmImplant Direct Legacy 3 implantdiameters 3.7, 4.2, 4.7, 5.2mmSurgikor Versatile for 3.5, 3.75, 4.2,4.5, 5.0, 6.0mm diameter implants	Nobel Active implant diameters 3.5,4.3, 5.5mmBiohorizons Tapered Tissue Levelimplant diameters 3.8, 4.6mmImplant Direct Legacy 3 implantdiameters 3.7, 4.2, 4.7, 5.2, 5.7mmNeodent Grand Morse implantdiameters 3.5, 3.75, 4.0, 4.3 and 5.0mmMIS Seven implant diameters 3.75,4.2, 5.0, 6.0mm
Surgikor Fixation for 3.5, 3.9, 4.3, 5.0mm diameter implantsSurgikor Solution for 3.5, 4.0, 4.5, 5.0, 5.5, 6.0mm diameter implantsNeodent Grand Morse implant diameters 3.5, 3.75, 4.0, 4.3 and 5.0 mmMIS Seven implant diameters 3.75, 4.2, 5, and 6mmZimmer Tapered Screw-Vent implant diameters 3.7, 4.1 and 4.7mmHiossen ETIII 3.5, 4.0, 4.5, 5.0, and 5.5mm implant diameters	Zimmer Tapered Screw-vent implant diameters 3.7, 4.1, 4.7 and 6.00mmHiossen ET III implant diameters 3.5, 4.0, 4.5, 5.0, 6.0, 7.0mm
SIN Cone Morse 11.5° and 16° implant lines11.5° Strong SW/SW Plus implant diameters 3.5, 3.8, 4.5, 5.0mmUnitite implant diameters 3.5, 4.0,4.3, 5.0, 6.0 Tryon CM Conical implant diameters 3.5, 4.5, 5.0Tryon CM Cylindrical implant diameters 3.5, 3.75, 4.0, 5.0 Epikut CM/CM Plus implant diameters 3.5, 3.8, 4.0, 4.5, 5.016 ° Strong SW CM/CM Plus implant diameters 3.5, 3.8, 4.5 and 5.0mm Epikut S/S Plus implant diameters 3.5, 3.8, 4.0, 4.5, 5.0mm	Neodent GM Interface with gingival heights of 1,2,3,4,5,6mmHiosen ETIII Mini and Regular Interfaces with gingival heights of 1,2,3,4,5,6mmBiohorizons Tapered Pro 3.5 Interface/MIS Seven Standard Interface/Zimmer 3.5 Interface/Implant Direct Legacy 3.5	Neodent GM Interface with gingival heights of 1,2,3,4,5,6mmHiosen ETIII Mini and Regular Interfaces with gingival heights of 1,2,3,4,5,6mmBiohorizons Tapered Pro 3.5 Interface/MIS Seven Standard Interface/Zimmer 3.5 Interface/Implant Direct Legacy 3.5
Abutments are available in the following platform and gingival height descriptions

	Interface/Surgikor Hex Interfacewith gingival heights of1,2,3,4,5,6mm	Interface/Surgikor Hex Interface withgingival heights of 0, 1, 2.5, 3.5, 4.5,5.5, 6.5mm
	Biohorizons Tapered Pro Wideinterface/MIS Seven WideInterface/Zimmer 4.5interface/Implant Direct LegacyWide Interface with gingivalheights of 1,2,3,4,5,6mm	Biohorizons Tapered Pro Wideinterface/MIS Seven WideInterface/Zimmer 4.5interface/Implant Direct Legacy WideInterface with gingival heights of0,1,2,3,4,5,6mm
	Nobel Active NP Interface/SurgikorRC Interface with gingival heightsof 1,2,3,4,5,6mm	Nobel Active NP Interface/SurgikorRC Interface with gingival heights of1,2,3,4,5,6mm
	Nobel Active RP Interface/SurgikorWC Interface with gingival heightsof 1,2,3,4,5,6mm	Nobel Active RP Interface/SurgikorWC Interface with gingival heights of1,2,3,4,5,6mm
	SIN 11.5° Cone Morse and 16°Cone Morse with gingival heightsof 1,2,3,4,5,6mm
Indications for Use	J & P Click Attachments aredesigned to support fixed, partialor full arch restorations onendosseous dental implants in themandible or maxilla for thepurpose of restoring masticatoryfunction. They are used in fixedhybrid restorations that can beattached with a click in system.Click attachments are indicated foruse with vertical implantplacements.	The High Retention AttachmentSystem is designed to support fixed,partial or full arch restorations onendosseous dental implants inthe mandible or maxilla for thepurpose of restoring masticatoryfunction. It is used in fixed hybridrestorations that can be attachedwith a snap-in system.
Material	Ti6Al4V	Ti6Al4V
Mechanism of action	Used with various dental implantsystems to make fixed hybridrestorations	Used with various dental implantsystems to make fixed hybridrestorations

{7}------------------------------------------------

{8}------------------------------------------------

Conclusion:

J & P Click Attachments are substantially equivalent to Zest High Retention Attachments. They both have the same indications for use (other than the vertical implant placement restriction), same mechanism of action, are of the same material, have the similar implant system compatibilities, and similar platform interfaces and gingival heights. Vertically placed implants are included in the indications for the predicate device so the indications for the subject device are a subset of those of the predicate. The

{9}------------------------------------------------

indications only being a subset of the predicate indications do not change the substantial equivalence because the restriction is there to make the devices safer and it does not change the other parts of the indications for use. Those interfaces not found in the predicate device are found in reference devices. The attachment designs are very similar between the predicate device and the current submission. Any differences in attachment design are slight differences in the dimensions which do not change the substantial equivalence of the two devices.

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)