T3 Pro Implants

K213672 · Biomet 3i, LLC · DZE · Mar 28, 2022 · Dental

Device Facts

• Record ID: K213672
• Device Name: T3 Pro Implants
• Applicant: Biomet 3i, LLC
• Product Code: DZE · Dental
• Decision Date: Mar 28, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The T3 Pro 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. The T3 Pro Implants may also utilize immediate loading for these indications. The T3 Pro 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.

Device Story

T3 Pro Implants are screw-type endosseous dental implants; tapered body geometry; manufactured from commercially pure titanium (ASTM F67). Designed for surgical placement in upper or lower jaw; provide prosthetic attachment for single/multiple tooth restorations, bridgework, or overdentures. Features internal hex connection for mating with Biomet 3i restorative components; roughened apex; OSSEOTITE coronal surface. Used in dental clinics by trained clinicians. Implants provide primary stability to restore chewing function; support delayed or immediate loading protocols. Supplied sterile via gamma irradiation; single-use; 5-year shelf life.

Clinical Evidence

No clinical data were included in this submission. Substantial equivalence is supported by bench testing, including mechanical performance comparisons, sterility validation (ISO 11137-1/2), biocompatibility (ISO 10993-1), and pyrogenicity testing (LAL Endotoxin Analysis). MR compatibility is leveraged from reference device K150571.

Technological Characteristics

Endosseous screw-type dental implant; tapered geometry. Material: Commercially Pure Titanium (ASTM F67). Surface: Grit-blasted with Calcium Phosphate dual-acid etching (OSSEOTITE). Connection: Internal hex. Sterilization: Gamma irradiation. Shelf life: 5 years. Dimensions: Diameters 3.25mm-6mm; lengths 8.5mm-15mm.

Indications for Use

Indicated for patients requiring dental implants in the upper or lower jaw for single tooth restorations, partially or fully edentulous spans, fixed or removable bridgework, or overdenture retention. Suitable for delayed or immediate loading when primary stability is achieved.

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

• 3i T3 Dental Implants (K122300)

Reference Devices

• 3i T3 Short Implants (K150571)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

Re: K213672

Trade/Device Name: T3 Pro Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: February 24, 2022 Received: February 25, 2022

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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K213672

Device Name T3 Pro Implants

Indications for Use (Describe)

The T3 Pro 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.

The T3 Pro Implants may also utilize immediate loading for these indications. The T3 Pro 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.

**Type of Use (Select one or both, as applicable)**X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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## T3 Pro Implants 510(k) Summary K213672 03/28/2022

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 krupal.patel(@zimmerbiomet.com Email:

- II. Proprietary Trade Name: T3 Pro Implants
- III. Device Classification Name: Implant, Endosseous, Root-Form (21 CFR 872.3640)
- IV. Regulatory Class: Class II
- V. Product Code: DZE
- Predicate Devices: VI.

Primary Predicate device:

- 3i T3 Dental Implants (K122300) ●
Reference device:

- 3i T3 Short Implants (K150571)
#### VII. Product Description:

The T3 Pro 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 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

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box. The device is sold sterile. The shelf life of the T3 Pro 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. The implants are offered in a variety of diameters and lengths to accommodate varying patient anatomy.

#### VIII. Indications for Use:

The T3 Pro 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.

The T3 Pro Implants may also utilize immediate loading for these indications. The T3 Pro 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.

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

The T3 Pro 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 delayed and immediate loading to reflect the information that was included for the primary predicate device labeling which includes delayed and immediate loading. The technological characteristics such as implant diameters, length, connection & platform geometry, and the mating abutments are same 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 predicate device, T3 Pro Implant are manufactured out of commercially pure titanium per ASTM F67. The primary change from the predicate devices is implant collar and thread form. Also. T3 Pro Implant are offered in tapered design only.

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

| Feature | Subject Device<br>T3 Pro Dental Implants | Primary Predicate Device<br>3i T3 Dental Implants (K122300) | |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| Intended Use/<br>Indications for Use | The T3 Pro 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 or immediate loading, or as | Biomet 3i 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, or as a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures. | |
| Feature | Subject Device<br>T3 Pro Dental Implants | Primary Predicate Device<br>3i T3 Dental Implants (K122300) | |
| | a terminal or intermediary abutment<br>for fixed or removable bridgework,<br>and to retain overdentures.<br><br>The T3 Pro Implants may also<br>utilize immediate loading for these<br>indications. The T3 Pro Implants<br>are intended for immediate function<br>on single tooth and/or multiple<br>tooth applications when good<br>primary stability is achieved, with<br>appropriate occlusal loading, in<br>order to restore chewing function. | | |
| Operating<br>Principle | The T3 Pro Dental Implants achieve<br>their intended purpose based upon<br>their macro design features, which<br>maximize primary stability at time<br>of placement. | The 3i T3 Dental Implants achieve<br>their intended purpose based upon<br>their macro design features, which<br>maximize primary stability at time<br>of placement. | |
| Fundamental<br>Scientific<br>Technology | Endosseous Dental Implants;<br>Screw-type designs | Endosseous Dental Implants;<br>Screw-type designs | |
| Material | Commercially Pure Titanium (CP4)<br>Per ASTM F67 | Commercially Pure Titanium (CP4)<br>Per ASTM F67 | |
| Implant Body<br>Diameter Range | Ø3.25mm, 4mm, 5mm and 6mm | Ø3.25mm, 4mm, 5mm and 6mm | |
| Seating Platform<br>Diameter | Ø3.4mm, 4.1mm, 5mm and 6mm | Ø3.4mm, 4.1mm, 5mm and 6mm | |
| | Ø3.25: 8.5mm, 10mm, 11.5mm,<br>13mm and 15mm | Ø3.25: 8.5mm, 10mm, 11.5mm,<br>13mm, 15mm and 18mm | |
| | Ø4.0: 8.5mm, 10mm, 11.5mm,<br>13mm and 15mm | Ø4.0: 8.5mm, 10mm, 11.5mm,<br>13mm, 15mm and 18mm | |
| Implant Length | Ø5.0: 8.5mm, 10mm, 11.5mm,<br>13mm and 15mm | Ø5.0: 8.5mm, 10mm, 11.5mm,<br>13mm and 15mm | |
| | Ø6.0: 8.5mm, 10mm, 11.5mm,<br>13mm and 15mm | Ø6.0: 8.5mm, 10mm, 11.5mm,<br>13mm and 15mm | |
| Platform Geometry | Platform Switched and<br>Non-Platform Switched Implants | Platform Switched and<br>Non-Platform Switched Implants | |
| Internal External<br>Geometry Design | Tapered only | Parallel Walled and Tapered | |
| Implant/Abutment<br>Mating Connection | Internal Hex | Internal Hex | |
| Implant Collar<br>Design | Straight Shortened Collar Design | Straight Collar Design | |
| Feature | Subject Device<br>T3 Pro Dental Implants | Primary Predicate Device<br>3i T3 Dental Implants (K122300) | |
| Surface Finish | Grit Blasted with Calcium Phosphate (CaP) Dual-acid Etching (OSSEOTITE®) Without DCD | Grit Blasted with Calcium Phosphate (CaP) Dual-acid Etching (OSSEOTITE®) With or without DCD | |
| | Thread Form | Subject Tapered Implant:<br>23° thread & 0.8mm pitch | Predicate Tapered Implant:<br>35° thread & 0.8mm pitch |
| | Anodized Platform<br>Surface Color | Purple, Blue, Yellow and Green | Purple, Blue, Yellow and Green |
| Mating<br>Components | Biomet 3i Internal Connection<br>Restorative Components | Biomet 3i Internal Connection<br>Restorative Components | |
| Sterilization<br>Method | Supplied Sterile (Gamma radiation) | Supplied Sterile (Gamma radiation) | |
| Shelf Life | 5 years | 5 years | |
| Single Use | Yes | Yes | |

## Table 1: Substantial equivalence table

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#### X. Non-Clinical Testing:

The worst-case comparison for the subject devices have demonstrated substantially equivalent to K122300 with regard to mechanical performance. MR compatibility testing to support the MR conditional labeling is leveraged from K150571, where testing was conducted on the worst case cleared Biomet 3i device constructs. The subject devices do not introduce a new worst-case.

Non-clinical data submitted or relied upon to demonstrate substantial equivalence included radiation sterilization validation according to ISO 11137-1 and 11137-2, demonstration a sterility assurance level (SAL) of 106, biological evaluation according to ISO 10993-1 demonstrating acceptable biocompatibility and accelerated and real time aging studies by reference to K122300 demonstrating a shelf life of five years.

Pyrogenicity information provided is based on FDA Guidance on "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile, issued on 21 January 2016." The method used to determine the device meets pyrogen limit specifications is LAL Endotoxin Analysis with testing limit of 20 EU/device, based on a blood contacting and implanted device.

No clinical data were included in this submission.

#### XI. Conclusion:

The subject devices have demonstrated substantial equivalence to the predicate devices in that they utilize same materials and fundamental designs and also have the same intended use and principles of operation.