(340 days)
Zest Anchors K220252
No
The summary describes a mechanical dental attachment system and its compatibility with various existing implant systems. There is no mention of software, algorithms, or any functionality that would suggest the use of AI or ML.
No.
The device is described as "attachments [...] designed to support fixed, partial or full arch restorations on endosseous dental implants [...] for the purpose of restoring masticatory function." This indicates it is a restorative device, not a therapeutic one. While it helps restore function, it does not treat a disease or condition in a therapeutic sense.
No
The device description indicates that J & P Click Attachments are designed to support fixed, partial or full arch restorations and provide a rigid connection to dental implants for restoring masticatory function. There is no mention of it being used to diagnose a medical condition.
No
The device description explicitly states that the device consists of physical components: abutments, attachment housings, and inserts, made from Ti-6AL-4V ELI. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the J & P Click Attachments are designed to support fixed, partial or full arch restorations on dental implants for restoring masticatory function. This is a mechanical function within the body.
- Device Description: The device description details the components (abutments, housings, inserts) and materials (Ti-6AL-4V ELI) used to create a physical connection for dental restorations.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze biological samples. This device is implanted within the body to provide structural support for dental prosthetics.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
NHA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible or maxilla
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Zest Anchors K220252
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.)
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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.
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.
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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.
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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
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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)
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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
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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:
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
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
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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 Comparison | ||
| Table | J & P Click Attachments | Zest High Retention Attachments |
| K220252 | ||
| Sterilization of | ||
| abutments | Provided non-sterile with | |
| instructions for user to sterilize | ||
| them | Provided non-sterile with instructions | |
| for user to sterilize them | ||
| Abutments available | ||
| for these implant | ||
| systems | Nobel Active implant diameters | |
| 3.5, 4.3, and 5.00mm | ||
| NobelParallel implant diameters | ||
| 3.75, 4.3, and 5.0mm | ||
| NobelReplace implant diameters | ||
| 3.5, 4.3 and 5.0mm | ||
| Biohorizons Tapered Tissue Level | ||
| implant diameters 3.8, 4.6mm | ||
| Implant Direct Legacy 3 implant | ||
| diameters 3.7, 4.2, 4.7, 5.2mm | ||
| Surgikor Versatile for 3.5, 3.75, 4.2, | ||
| 4.5, 5.0, 6.0mm diameter implants | Nobel Active implant diameters 3.5, | |
| 4.3, 5.5mm | ||
| Biohorizons Tapered Tissue Level | ||
| implant diameters 3.8, 4.6mm | ||
| Implant Direct Legacy 3 implant | ||
| diameters 3.7, 4.2, 4.7, 5.2, 5.7mm | ||
| Neodent Grand Morse implant | ||
| diameters 3.5, 3.75, 4.0, 4.3 and 5.0 | ||
| mm | ||
| MIS Seven implant diameters 3.75, | ||
| 4.2, 5.0, 6.0mm | ||
| 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 implant diameters 3.5, 3.75, 4.0, 4.3 and 5.0 mm | ||
| MIS Seven implant diameters 3.75, 4.2, 5, and 6mm | ||
| Zimmer Tapered Screw-Vent implant diameters 3.7, 4.1 and 4.7mm | ||
| Hiossen 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 6.00mm | |
| Hiossen ET III implant diameters 3.5, 4.0, 4.5, 5.0, 6.0, 7.0mm | ||
| 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/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 1,2,3,4,5,6mm | |
| Hiosen ETIII Mini and Regular Interfaces with gingival heights of 1,2,3,4,5,6mm | ||
| Biohorizons 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 1,2,3,4,5,6mm | |
| Hiosen ETIII Mini and Regular Interfaces with gingival heights of 1,2,3,4,5,6mm | ||
| Biohorizons 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 Interface | ||
| with gingival heights of | ||
| 1,2,3,4,5,6mm | Interface/Surgikor Hex Interface with | |
| gingival heights of 0, 1, 2.5, 3.5, 4.5, | ||
| 5.5, 6.5mm | ||
| Biohorizons Tapered Pro Wide | ||
| interface/MIS Seven Wide | ||
| Interface/Zimmer 4.5 | ||
| interface/Implant Direct Legacy | ||
| Wide Interface with gingival | ||
| heights of 1,2,3,4,5,6mm | Biohorizons Tapered Pro Wide | |
| interface/MIS Seven Wide | ||
| Interface/Zimmer 4.5 | ||
| interface/Implant Direct Legacy Wide | ||
| Interface with gingival heights of | ||
| 0,1,2,3,4,5,6mm | ||
| Nobel Active NP Interface/Surgikor | ||
| RC Interface with gingival heights | ||
| of 1,2,3,4,5,6mm | Nobel Active NP Interface/Surgikor | |
| RC Interface with gingival heights of | ||
| 1,2,3,4,5,6mm | ||
| Nobel Active RP Interface/Surgikor | ||
| WC Interface with gingival heights | ||
| of 1,2,3,4,5,6mm | Nobel Active RP Interface/Surgikor | |
| WC Interface with gingival heights of | ||
| 1,2,3,4,5,6mm | ||
| SIN 11.5° Cone Morse and 16° | ||
| Cone Morse with gingival heights | ||
| of 1,2,3,4,5,6mm | ||
| Indications for Use | 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. | The High Retention Attachment | |
| System is 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. It is used in fixed hybrid | ||
| restorations that can be attached | ||
| with a snap-in system. | ||
| Material | Ti6Al4V | 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 |
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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.