Immediate Molar Implants

K241753 · Biomet 3i, LLC · DZE · Oct 23, 2024 · Dental

Device Facts

• Record ID: K241753
• Device Name: Immediate Molar Implants
• Applicant: Biomet 3i, LLC
• Product Code: DZE · Dental
• Decision Date: Oct 23, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Immediate Molar Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures. Immediate Molar Dental Implants may also utilize immediate loading for these indications. Immediate Molar Dental Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. The Immediate Molar Dental Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to provide good primary stability. The Immediate Molar Dental Implants are intended for implantation in the maxillary or mandibular molar region where bone exists and the surgeon has determined that the placement of a narrower diameter implant would increase the probability of failure due to poor primary stability, or increased surgical procedures leading to complications. The Immediate Molar Dental Implants are also indicated for compatibility with the following OEM abutment systems: Abutments manufactured by Terrats Medical SL (Titanium Abutments, 4.1, 5.0 and 5.7mm) and Abutments manufactured by Zfx GmbH (Titanium Abutments, 4.1, 5.0 and 5.7mm).

Device Story

Immediate Molar Implants are screw-type, tapered endosseous dental implants; manufactured from Commercially Pure Titanium (ASTM F67); feature roughened apex and OSSEOTITE coronal surface. Implants placed in maxillary or mandibular molar regions; intended for single or multiple tooth restorations; support immediate or delayed loading. Surgeon performs osteotomy; implants provide primary stability for prosthetic attachment. Compatible with Biomet 3i internal hex, Zimmer Dental TSV internal connection components, and specific titanium abutments from Terrats Medical SL and Zfx GmbH. Device supplied sterile via gamma irradiation; single-use; 5-year shelf life. Output is stable base for dental prosthetics; restores chewing function; benefits patients by providing robust support in molar regions where narrower implants might fail.

Clinical Evidence

No clinical data were included in this submission. Substantial equivalence is supported by non-clinical bench testing, including mechanical fatigue performance, pull-out tests, and surface area analysis. Sterilization validated per ISO 11137-1/2 (SAL 10-6); biocompatibility per ISO 10993-1; shelf life supported by accelerated and real-time aging studies.

Technological Characteristics

Material: Commercially Pure Titanium (ASTM F67). Design: Tapered screw-type, platform-switched. Surface: Grit-blasted with Calcium Phosphate (ASTM F1185) and dual-acid etched (OSSEOTITE). Connection: Internal hex. Sterilization: Gamma irradiation. Shelf life: 5 years. Connectivity: None (mechanical device).

Indications for Use

Indicated for surgical placement in upper or lower jaw for prosthetic attachment in single tooth restorations, partially or fully edentulous spans, fixed or removable bridgework, and overdentures. Suitable for immediate or delayed loading when primary stability is achieved. Indicated for maxillary or mandibular molar regions where wider diameter implants are preferred to avoid failure or complications. For use by surgeons.

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

• T3 PRO Implants (K213672)

Reference Devices

• TSX Implants (K220978)
• Tapered Screw Vent Implants (K013227)
• 3i T3 Short Dental Implants (K150571)
• Implanova (K210523)
• Southern Implants MAX Implant System (K191054)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 23, 2024

Biomet 3i, LLC Krupal Patel Regulatory Affairs Principal 4555 Riverside Drive Palm Beach Gardens, Florida 33410

Re: K241753

Trade/Device Name: Immediate Molar Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: June 18, 2024 Received: September 19, 2024

Dear Krupal Patel:

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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 ([e-mail]) or phone [phone] 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: K241753

Device Name: Immediate Molar Implants

### Indications for Use:

Immediate Molar Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.

Immediate Molar Dental Implants may also utilize immediate loading for these indications. Immediate Molar Dental Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. The Immediate Molar Dental Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to provide good primary stability. The Immediate Molar Dental Implants are intended for implantation in the maxillary or mandibular molar region where bone exists and the surgeon has determined that the placement of a narrower diameter implant would increase the probability of failure due to poor primary stability, or increased surgical procedures leading to complications.

The Immediate Molar Dental Implants are also indicated for compatibility with the following OEM abutment systems:

| Abutment System Name | Models | Platform Diameters |
|-------------------------------------------------|--------------------|--------------------|
| Abutments manufactured by<br>Terrats Medical SL | Titanium Abutments | 4.1, 5.0 and 5.7mm |
| Abutments manufactured by<br>Zfx GmbH | Titanium Abutments | 4.1, 5.0 and 5.7mm |

| Prescription Use | X |
|------------------|---|
|------------------|---|

(Part 21 CFR 801 Subpart D) and/or

| Over-The-Counter Use | |
|----------------------|--|
|----------------------|--|

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Product Evaluation and Quality (OPEQ)

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### Immediate Molar Implants 510(k) Summary 21 CFR 807.92 23-Oct-2024

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92

#### I. Submitter Information:

| Name: | Biomet 3i LLC |
|----------|-----------------------------------------------------------|
| Address: | 4555 Riverside Drive<br>Palm Beach Gardens, Florida 33410 |
| Phone: | [phone] |
| Fax: | [phone] |

| Contact Person: | Krupal Patel |
|-----------------|---------------------------------|
| Job Title: | Principal Regulatory Specialist |
| Email: | [e-mail] |

- II. Proprietary Trade Name: Immediate Molar Implants
- III. Device Classification Name: Implant, Endosseous, Root-Form (21 CFR 872.3640)
- IV. Regulatory Class: Class II
- V. Product Code: DZE

#### VI. Predicate Devices:

Primary Predicate Device:

- T3 PRO Implants (K213672)
Reference Predicate Devices:

- . TSX Implants (K220978)
- Tapered Screw Vent Implants (K013227)
- 3i T3 Short Dental Implants (K150571) ●
- Implanova (K210523)
- . Southern Implants MAX Implant System (K191054)

#### VII. Product Description:

The Immediate Molar Implants are basic screw-type designs available in tapered body geometry. The devices are manufactured from Commercially Pure Titanium (ASTM F67) and feature a roughened apex and traditional OSSEOTITE® coronal surface. The device is

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packaged in a Titanium sleeve that is inserted into a polypropylene inner tray, covered with a Tyvek lid and heat-sealed. This assembly is then placed inside a larger polyethylene thermoformed outer tray, covered with a Tyvek lid and heat-sealed. The outer tray is packaged inside a box. The device is sold sterile. The shelf life of the Immediate Molar Implants is 5 years and they are intended for single use only. The device is sterilized using gamma irradiation method. The implants are available in various platform options and feature an internal hex connection for mating with associated Biomet 3i internal connection restorative components and also a TSV connection for mating with associated Zimmer Dental TSV connection restorative components. The implants are also compatible with titanium abutments manufactured by Terrats Medical SL and Zfx GmbH. The implants are offered in a variety of diameters and lengths to accommodate varying patient anatomy. The T3 PRO Immediate Molar Implants are offered in 8, 10 and 11.5mm implant lengths for each of the implant body diameter sizes of 7, 8 and 9mm. The TSX Immediate Molar Implants are offered in 6, 8, 10 and 11.5mm implant lengths for each of the implant body diameter sizes of 7 and 8mm. The TSX Immediate Molar Implants are offered in 8, 10 and 11.5mm lengths for implant body diameter size of 9mm.

#### VIII. Indications for Use:

Immediate Molar Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.

Immediate Molar Dental Implants may also utilize immediate loading for these indications. Immediate Molar Dental Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. The Immediate Molar Dental Implants may be placed immediately following an extraction or loss of natural teeth provided there is sufficient volume of alveolar bone to provide good primary stability. The Immediate Molar Dental Implants are intended for implantation in the maxillary or mandibular molar region where bone exists and the surgeon has determined that the placement of a narrower diameter implant would increase the probability of failure due to poor primary stability, or increased surgical procedures leading to complications.

The Immediate Molar Dental Implants are also indicated for compatibility with the following OEM abutment systems:

| Abutment System Name | Models | Platform Diameters |
|-------------------------------------------------|--------------------|--------------------|
| Abutments manufactured by<br>Terrats Medical SL | Titanium Abutments | 4.1, 5.0 and 5.7mm |
| Abutments manufactured by<br>Zfx GmbH | Titanium Abutments | 4.1, 5.0 and 5.7mm |

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#### IX. Summary of the Technological Characteristics:

The Immediate Molar Implant devices are identical to the predicate devices listed below in terms of operating principle and material. The subject device Indications for Use adds language for immediate implant placement to reflect the information that was included for the reference predicate device labeling which includes immediate implant placement. The technological characteristics such as length, connection & platform geometry, and the mating abutments are identical as the predicate devices. The subject device features a tapered design with a similar screw-type design and thread form as the predicate device. Like the primary predicate device, Immediate Molar Implant are manufactured out of commercially pure titanium per ASTM F67. The primary change from the predicate devices is implant diameter and thread form. Also, Immediate Molar Implant are offered in platform switched design only.

A substantial equivalence comparison of subject and predicate device is provided in table below.

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| Feature | Subject Device<br>Immediate Molar<br>Dental Implants | Primary Predicate<br>Device<br>T3 PRO Dental<br>Implants (K213672) | Reference Predicate<br>Device<br>TSX Dental Implants<br>(K220978) | Reference Predicate<br>Device<br>TSV Dental Implants<br>(K013227) | Reference Predicate<br>Device<br>3i T3 Short Dental<br>Implants (K150571) | Reference Predicate<br>Device<br>Implanova<br>(K210523) | Reference Predicate<br>Device<br>Southern Implants<br>MAX Implant<br>System (K191054) | | | | | | | | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--------------------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------|---------------------------------------------------------------------------------------|
| Intended<br>Use/<br>Indications<br>for Use | Immediate Molar<br>Dental Implants are<br>intended for surgical<br>placement in the<br>upper or lower jaw<br>to provide a means<br>for prosthetic<br>attachment in single<br>tooth restorations<br>and in partially or<br>fully edentulous<br>spans with multiple<br>single teeth utilizing<br>delayed loading, or<br>with a terminal or<br>intermediary<br>abutment for fixed or<br>removable<br>bridgework, and to<br>retain overdentures.<br>Immediate Molar<br>Dental Implants may<br>also utilize<br>immediate loading<br>for these indications.<br>Immediate Molar<br>Dental Implants are<br>intended for<br>immediate function | The T3 Pro Dental<br>Implants are intended<br>for surgical placement<br>in the upper or lower<br>jaw to provide a means<br>for prosthetic<br>attachment in single<br>tooth restorations and<br>in partially or fully<br>edentulous spans with<br>multiple single teeth<br>utilizing delayed or<br>immediate loading, or<br>as a terminal or<br>intermediary abutment<br>for fixed or removable<br>bridgework, and to<br>retain overdentures.<br>The T3 Pro Implants<br>may also utilize<br>immediate loading for<br>these indications. The<br>T3 Pro Implants are<br>intended for immediate<br>function on single tooth<br>and/or multiple tooth<br>applications when good<br>primary stability is<br>achieved, with | The TSX Implants are<br>designed for use in<br>the maxilla or<br>mandible for<br>immediate loading or<br>for loading after a<br>conventional healing<br>period. Implants may<br>be used to replace one<br>or more missing<br>teeth. Immediate<br>loading is indicated<br>when there is good<br>primary stability and<br>an appropriate<br>occlusal load.<br>Implants may be<br>placed immediately<br>following an<br>extraction or loss of<br>natural teeth provided<br>there is sufficient<br>volume of alveolar<br>bone to minimally<br>support the implant<br>(minimum 1mm<br>circumferential and<br>2mm apical) and<br>provide good primary<br>stability. | The Tapered Screw-<br>Vent and Screw-Vent<br>Implants are intended<br>for surgical<br>implantation in<br>edentulous mandibles<br>or maxillae for<br>attachment of<br>complete denture<br>prostheses, or as a<br>terminal or<br>intermediary<br>abutment for fixed or<br>removable<br>bridgework, or as a<br>freestanding single<br>tooth replacement. | The 3i T3 Short are<br>intended for surgical<br>placement in the<br>upper or lower jaw to<br>provide a means for<br>prosthetic attachment<br>in single tooth<br>restorations and in<br>partially or fully<br>edentulous spans<br>with multiple single<br>teeth utilizing<br>delayed loading, or<br>with a terminal or<br>intermediary<br>abutment for fixed or<br>removable<br>bridgework, and to<br>retain overdentures. | The Implanova®<br>implants are intended<br>for endosseous<br>implantation in the<br>mandible and maxilla<br>for use as an artificial<br>root structure. These<br>root form implants<br>can be used to<br>replace single or<br>multiple teeth<br>missing teeth and/or<br>to support a fixed or<br>removable prosthesis<br>in partially or<br>completely<br>edentulous upper and<br>lower dental arches.<br>Implanova® All-in-<br>One™ implants are<br>indicated to be used<br>when primary<br>stability of the<br>implant allows<br>presence of an<br>abutment at the time<br>of placement.<br>Implanova® All-in-<br>one™ are | Southern Implants<br>MAX implant is<br>intended for<br>implantation in<br>maxillary or<br>mandibular molar<br>region where bone<br>exists and the<br>surgeon has<br>determined that the<br>placement of a<br>narrower diameter<br>implant would<br>increase the<br>probability of failure<br>due to poor primary<br>stability, or increased<br>surgical procedures<br>leading to<br>complications. This<br>MAX implant<br>provides support for<br>fixed or removable<br>dental prostheses in a<br>single tooth, partially<br>edentulous prostheses<br>or full arch<br>prostheses. It further<br>adds the option for<br>immediate loading on | | | | | | | | | | |
| Feature | Subject Device<br>Immediate Molar<br>Dental Implants | Primary Predicate<br>Device<br>T3 PRO Dental<br>Implants (K213672) | Reference Predicate<br>Device<br>TSX Dental Implants<br>(K220978) | Reference Predicate<br>Device<br>TSV Dental Implants<br>(K013227) | Reference Predicate<br>Device<br>3i T3 Short Dental<br>Implants (K150571) | Reference Predicate<br>Device<br>Implanova<br>(K210523) | Reference Predicate<br>Device<br>Southern Implants<br>MAX Implant<br>System (K191054) | | | | | | | | | | |
| on single tooth<br>and/or multiple tooth<br>applications when<br>good primary<br>stability is achieved,<br>with appropriate<br>occlusal loading, in<br>order to restore<br>chewing function.<br>The Immediate<br>Molar Dental<br>Implants may be<br>placed immediately<br>following an<br>extraction or loss of<br>natural teeth<br>provided there is<br>sufficient volume of<br>alveolar bone to<br>provide good<br>primary stability.<br>The Immediate<br>Molar Dental<br>Implants are<br>intended for<br>implantation in the<br>maxillary or<br>mandibular molar<br>region where bone<br>exists and the<br>surgeon has<br>determined that the | appropriate occlusal<br>loading, in order to<br>restore chewing<br>function. | The 3.1mmD TSX<br>Implants should be<br>splinted to additional<br>implants when used in<br>the pre-molar region<br>and should not be<br>used in the molar<br>region. | | | immediately loaded<br>by the presence of the<br>abutment, but the<br>occlusal forces need<br>to be controlled and<br>restricted while<br>osseointegration<br>takes place. | single and splinted<br>multiple unit<br>restorations when<br>good primary<br>stability is achieved<br>and with appropriate<br>occlusal loading, to<br>restore chewing<br>function. | | | | | | | | | | | |
| Feature | Subject Device<br>Immediate Molar<br>Dental Implants | Primary Predicate<br>Device<br>T3 PRO Dental<br>Implants (K213672) | Reference Predicate<br>Device<br>TSX Dental Implants<br>(K220978) | Reference Predicate<br>Device<br>TSV Dental Implants<br>(K013227) | Reference Predicate<br>Device<br>3i T3 Short Dental<br>Implants (K150571) | Reference Predicate<br>Device<br>Implanova<br>(K210523) | Reference Predicate<br>Device<br>Southern Implants<br>MAX Implant<br>System (K191054) | | | | | | | | | | |
| | placement of a<br>narrower diameter<br>implant would<br>increase the<br>probability of<br>failure due to poor<br>primary stability, or<br>increased surgical<br>procedures leading<br>to complications.<br>The Immediate<br>Molar Dental<br>Implants are also<br>compatible with<br>titanium abutments<br>manufactured by<br>Terrats Medical S.L.<br>and Zfx GmbH | | | | | | | | | | | | | | | | |
| Operating<br>Principle | The Immediate<br>Molar Dental<br>Implants achieve<br>their intended<br>purpose based upon<br>their macro design<br>features, which<br>maximize primary<br>stability at time of<br>placement. | The T3 Pro Dental<br>Implants achieve their<br>intended purpose based<br>upon their macro<br>design features, which<br>maximize primary<br>stability at time of<br>placement. | The TSX Dental<br>Implants achieve<br>their intended<br>purpose based upon<br>their macro design<br>features, which<br>maximize primary<br>stability at time of<br>placement. | The Tapered Screw<br>Vent Dental Implants<br>are placed into a<br>prepared osteotomy<br>and once stability is<br>achieved; the implant<br>is restored with a<br>compatible<br>restorative device. | The 3i T3 Short<br>Dental Implants are<br>placed into a<br>prepared osteotomy<br>and once stability is<br>achieved, the implant<br>is restored with a<br>compatible<br>restorative device. | The Implanova<br>Dental Implants are<br>placed into a<br>prepared osteotomy<br>and once stability is<br>achieved, the implant<br>is restored with a<br>compatible<br>restorative device. | The Southern Max<br>Dental Implants are<br>placed into a<br>prepared osteotomy<br>and once stability is<br>achieved, the implant<br>is restored with a<br>compatible<br>restorative device. | | | | | | | | | | |
| Feature | Subject Device<br>Immediate Molar<br>Dental Implants | Primary Predicate<br>Device<br>T3 PRO Dental<br>Implants (K213672) | Reference Predicate<br>Device<br>TSX Dental Implants<br>(K220978) | Reference Predicate<br>Device<br>TSV Dental Implants<br>(K013227) | Reference Predicate<br>Device<br>3i T3 Short Dental<br>Implants (K150571) | Reference Predicate<br>Device<br>Implanova<br>(K210523) | Reference Predicate<br>Device<br>Southern Implants<br>MAX Implant<br>System (K191054) | | | | | | | | | | |
| Fundamental | Endosseous Dental | Endosseous Dental | Endosseous Dental | Endosseous Dental | Endosseous Dental | Endosseous Dental | Endosseous Dental | | | | | | | | | | |
| Scientific | Implants; | Implants; | Implants; | Implants; | Implants; | Implants; | Implants; | | | | | | | | | | |
| Technology | Screw-type designs | Screw-type designs | Screw-type designs | Screw-type designs | Screw-type designs | Screw-type designs | Screw-type designs | | | | | | | | | | |
| Material | Commercially Pure<br>Titanium (CP4)<br>Per ASTM F67 | Commercially Pure<br>Titanium (CP4)<br>Per ASTM F67 | Titanium Alloy (Ti-<br>6Al-4V ELI) per<br>ASTM F136 | Titanium Alloy (Ti-<br>6Al-4V ELI) per<br>ASTM F136 | Commercially Pure<br>Titanium (CP4)<br>Per ASTM F67 | Titanium Alloy<br>(ASTM F136) | Commercially Pure<br>Titanium (CP4)<br>Per ASTM F67 | | | | | | | |…