Bonafix 2 Plus

K213677 · Zentek Medical, LLC · DZE · Dec 20, 2022 · Dental

Device Facts

• Record ID: K213677
• Device Name: Bonafix 2 Plus
• Applicant: Zentek Medical, LLC
• Product Code: DZE · Dental
• Decision Date: Dec 20, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Bonafix 2 Plus Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient's esthetics and chewing function. Bonafix 2 Plus implants are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading.

Device Story

Bonafix 2 Plus is a bone-level endosseous dental implant system; manufactured from Grade 5 ELI Titanium Alloy (ASTM F136); features tapered body, double progressive thread, flat apex, and two-spiral apical channels for self-tapping. Crestal zone includes micro-rings. System includes cover screws, healing caps, and various abutments (straight, angled, multi-unit). Used by dental surgeons in clinical settings to support prosthetic restorations. Implant surface treated with RBM technology. Device provides mechanical support for artificial teeth; immediate loading permitted given sufficient primary stability. Healthcare providers use the device to restore patient chewing function and esthetics. Benefits include stable prosthetic support and functional restoration.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated through bench testing, including dynamic fatigue testing (ISO 14801), biocompatibility (ISO 10993), sterility validation (ISO 11137, ISO 17665), and MRI safety assessment.

Technological Characteristics

Material: Ti-6Al-4V ELI (ASTM F136). Surface: RBM treated. Connection: Internal hex. Dimensions: Diameters 3.5-6.0mm; Lengths 8-16mm. Sterilization: Gamma radiation (implants), Steam (abutments). Mechanical: Tapered body, double progressive thread, self-tapping apical channels.

Indications for Use

Indicated for patients requiring endosseous dental implants in the upper or lower jaw to support prosthetic devices (e.g., artificial teeth) to restore esthetics and chewing function. Intended for immediate loading when primary stability is achieved and occlusive loading is appropriate.

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

• MSDI Dental Implants System (K191443)

Reference Devices

• Neodent Implant System - Temporary Abutments (K191191)
• s-Clean Tapered II RBM Implant System (K160213)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.

Zentek Medical LLC % Juan Tezak Consultant Compliance 4 Devices 118 W Prive Cr. Delray Beach, Florida 33445

Re: K213677

Trade/Device Name: Bonafix 2 Plus Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: November 22, 2022 Received: November 22, 2022

Dear Juan Tezak:

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 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 Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K213677

Device Name Bonafix 2 Plus

Indications for Use (Describe)

Bonafix 2 Plus Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient's and chewing function. Bonafix 2 Plus implants are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|--|
| <div> <span> Prescription Use (Part 21 CFR 201 Subpart D) </span> </div> | |
| <div> <span> Over-The-Counter Use (21 CFR 201 Subpart C) </span> </div> | |

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### 510(k) Summary

Bonafix 2 Plus December 12th, 2022

#### ADMINISTRATIVE INFORMATION

Applicant

ZENTEK MEDICAL LLC 200 Craig Rd Ste 107 Manalapan, NJ 077268735 Phone: [phone]

#### Establishment Registration Number

Official Contact

Michael Vinnik Owner 200 Craig Rd Ste 107 Manalapan, NJ 077268735 [phone] E-mail: [e-mail]

Representative/Consultant

Juan Tezak Carlos Marín Compliance4Devices 118 W Prive Cr. Delray Beach Fl, 33445 Phone: [phone] E-mail: [e-mail]

#### DEVICE AND CLASSIFICATION NAME

| Device Trade Name: | Bonafix 2 Plus |
|----------------------------|--------------------------------|
| Common Name: | Endosseous dental implant |
| Classification Regulation: | 21 CFR 872.3640 |
| Classification Name: | Implant, Endosseous, Root-form |
| Device Classification: | Class II |
| Classification Panel: | Dental |
| Primary Product Code: | DZE |
| Secondary Product Code: | NHA |

#### PREDICATE DEVICES INFORMATION

Primary predicate K191443, MSDI Dental Implants System Reference devices K191191 Neodent Implant System - Temporary Abutments K160213, s-Clean Tapered II RBM Implant System

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#### Intended Use

Bonafix 2 Plus Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient's esthetics and chewing function. Bonafix 2 Plus implants are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading.

# Device Description

The current submission requests clearance for the Class II Bonafix 2 Plus implant system. The Bonafix 2 Plus Implant is a bone level type implant, built in Grade 5 ELI Titanium Alloy and treated with RBM technology. The implant has a conventional internal hex connection style. The crestal zone of implant have micro-rings. The design crestal zone (straight or tapered) depends on Implant diameter because the implant system has only one platform. The body of the implant is tapered, designed with a double progressive thread with a small internal channel at the bottom of the thread; and the apex of the implant has a flat shape. Has two-spiral channel at the apical end of the implant that provide self-tapping properties to the implant.

The implants are provided in several different dimensions, 3.5, 3.75, 4.2, 5.0, and 6.0mm of diameter, and lengths of 8, 10, 11.5, 13 and 16mm. Hex Connection 6.0 diameter implants do not come in 13 or 16mm length.

Cover screw, Healing Caps (3.8 and 4.6mm of diameters) and 3 types of abutments: Straight abutments, Angled abutment and Multi-unit abutments, are included in the system.

# Equivalence to Marketed Device

Bonafix 2 Plus is substantially equivalent to the MSDI Dental Implants System (K191443) predicate device in almost all of its characteristics. Is similar in terms of intended use, indications for use, operating principle, fundamental scientific technology, implant connections and material. The technological characteristics such as implant diameters, length, connection and platform geometry, as well as mating abutments are similar to that of the predicate devices, except for the temporary abutments which are similar to the reference device K191121.

Other differences with predicate device are on the surface treatment (RBM vs Grit blasted + Acid Etched Surface) but here is similar to reference device K160213.

The basis for Zentek Medical LLC belief that Bonafix 2 Plus is substantially equivalent to the predicated and referenced device is summarized in the following Tables of Substantial Equivalence.

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| Feature | Subject Device | Primary Predicate Device | Comparison |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name | Bonafix 2 Plus | MSDI Dental Implants System | |
| Indications for Use | Bonafix 2 Plus Implants are<br>endosseous implants intended<br>to be surgically placed in the<br>upper or lower jaw arches to<br>provide support for prosthetic<br>devices, such as an artificial<br>tooth, in order to restore<br>patient's esthetics and chewing<br>function. Bonafix 2 Plus implants<br>are intended for immediate<br>loading when good primary<br>stability is achieved, and with<br>appropriate occlusive loading. | MSDI Dental Implants System is<br>indicated for use in surgical and<br>restorative applications for<br>placement in the bone of the<br>upper or lower jaw to provide<br>support or prosthetic devices,<br>such as artificial teeth, in order<br>to restore the patient's chewing<br>function.<br>It is intended for immediate<br>loading when good primary<br>stability is achieved and with<br>appropriate occlusal loading. | Same |
| Connection | Internal hex | Internal Hexagon | Same |
| Diameter of Implants Hex Connection | 3.5mm<br>3.75mm<br>4.2mm<br>5.0mm<br>6.0mm | 3.3, 3.7, 4.2, 5.0 and 6.0 mm | Similar.<br>The predicate<br>device has a<br>smaller<br>diameter<br>implant. This<br>does not<br>affect the<br>substantial<br>equivalence<br>of the device.<br>a worse<br>performance<br>scenario |
| Implant Lengths (mm) | ⌀ 3.5mm<br>(8,10,11.5,13,16)<br>⌀ 3.75mm<br>(8,10,11.5,13,16)<br>⌀ 4.2mm<br>(8,10,11.5,13,16)<br>⌀ 5.0mm<br>(8,10,11.5,13,16)<br>⌀ 6.0mm<br>(8,10,11.5) | 8, 10, 11.5, 13 and 16mm | Same |
| Material | Ti-6Al-4V ELI (ASTM F136) | Titanium Alloy – Ti6Al4V ELI | Same |
| Cover screw | One size | One size | Same |
| Surface Treatment | RBM | Grit Blasted and Acid Etched<br>Surface | Different<br>Same as<br>Reference<br>device<br>K160213 |
| Sterilization of Implants | Gamma ray | Gamma ray | Same |
| Feature | Subject Device | Primary Predicate Device | Comparison |
| Device Trade Name | Bonafix 2 Plus | MSDI Dental Implants System | |

#### Table 1. Comparison with predicate device

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# Zentek Medical LLC

| Feature | Subject Device | Primary Predicate<br>Device | Reference<br>Device | |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Device Trade Name | Bonafix 2 Plus | MSDI Dental Implants<br>System (1) | Neodent Implant<br>System - Temporary<br>Abutments (2) | Comparison |
| Straight abutments | • Straight abutment<br>Ø4.5 / Length: 9 and<br>13 mm<br>Ø5.5 mm / Length: 9<br>and 12 mm<br>• Straight abutment<br>w/shoulder<br>Ø Standard / Tissue<br>height: 1, 2 and 3<br>• Anatomic straight<br>abutment<br>Ø Standard / Tissue<br>height: 1, 2 and 3. | • Standard Titanium<br>Abutment with<br>height of 7mm<br>• Standard narrow<br>abutment with<br>heights of 7, 9, and<br>11mm | N/A | (1) Similar. The<br>subject device<br>has<br>additionally<br>anatomical<br>and<br>w/shoulder<br>abutments.<br>(2) N/A |
| Angled abutments | • Angled abutments<br>Ø Standard<br>Degrees: 15° and 25°<br>• Anatomic angled<br>abutment<br>Ø Standard<br>Degrees: 15°<br>Tissue height: 1, 2<br>and 3.<br>• Anatomic angled<br>abutment<br>Ø Standard<br>Degrees: 25°<br>Tissue height: 1 and<br>2. | • Standard 15°<br>Abutment with<br>heights of 8, 12, and<br>13mm.<br>• Standard 25°<br>Abutment with<br>heights of 9 and<br>12mm | N/A | (1) Similar. The<br>subject device<br>has<br>additionally<br>anatomical<br>angled<br>abutments.<br>(2) N/A |
| Multi-unit<br>abutment (*) | • Multi-unit straight<br>abutment<br>Ø Standard<br>Tissue height: 1, 2, 3<br>and 4<br>• Angled multi-unit<br>abutment<br>Ø Standard<br>Degrees: 17°<br>Tissue height: 2 and<br>3<br>Degrees: 30°<br>Tissue height: 3 and<br>4 | Multi-unit abutments<br>in heights of 1,2,3 and<br>4 mm. | N/A | (1)<br>Similar. The<br>subject device<br>has<br>additionally<br>angled multi-<br>unit<br>abutments.<br>(2) N/A |

# Table 2. Comparison with predicate and referenced device for abutments

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# Zentek Medical LLC

| Feature | Subject Device | Primary Predicate<br>Device | Reference<br>Device | |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| Device Trade Name | Bonafix 2 Plus | MSDI Dental Implants<br>System (1) | Neodent Implant<br>System - Temporary<br>Abutments (2) | Comparison |
| Temporary<br>abutments | Design: Straight,<br>cylindrical with<br>retention rings.<br>Model: With Hex and<br>Without Hex<br>Diameter (Ø): 3.5<br>Angulation: Straight<br>Duration of use: 180<br>days | N/A | Design: Straight,<br>cylindrical with<br>retention rings.<br>Model: With Hex and<br>Without Hex<br>Diameter (Ø): 3.5 and<br>4.5<br>Angulation: Straight<br>Duration of use: 180<br>days | (1) Different<br>(2) Same as<br>the reference<br>device. |
| Sterilization of<br>abutments | Steam sterilization | Steam sterilization | Ethylene Oxide to an<br>SAL of 1x10-6 | (1) Same as the<br>reference<br>device.<br>(2) Different |
| Material | Ti-6Al-4V ELI (ASTM<br>F136) | Titanium Alloy -<br>Ti6Al4V ELI | Ti-6Al-4V ELI | (1) Same<br>(2) Same |

*These models of abutments are not for single crown use.

# Non-Clinical Testing Summary

Bench tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device based on the following standards:

| Standard | Version | Title |
|--------------------------|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ANSI/AAMI/ISO<br>17665-1 | 2006/<br>(R)2013 | Sterilization of health care products - Moist heat - Part 1: Requirements for<br>the development, validation and routine control of a sterilization process for<br>medical devices, Annex D. |
| ISO 10993-12 | 2012 | Biological evaluation of medical devices - Part 12: Sample preparation and<br>reference materials. |
| ASTM F2096-11 | 2013 | Standard Test Method for Detecting Gross Leaks in Medical Packaging by<br>Internal Pressurization (Bubble Test). |
| ISO 10993-5 | 2014 | Biological evaluation of medical devices - Part 5: Tests for in vitro<br>cytotoxicity. |
| ISO 14801 | 2016 | Dentistry--Implants--Dynamic Fatigue Tests for Endosseous Dental Implants. |
| ASTM F1980-16 | 2016 | Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical<br>Devices. |
| ASTM F88 | 2016 | Standard Test Method for Seal Strength of Flexible Barrier Materials (Peel Test). |
| ISO 10993-1 | 2018 | Biological evaluation of medical devices - Part 1: Evaluation and testing<br>within a risk management process. |
| ISO 11607-1 | 2019 | Packaging for terminally sterilized medical devices — Part 1: Requirements<br>for materials, sterile barrier systems and packaging systems. |
| ISO 11137-1 | 2006/(R)2015 | Sterilization of health care products - Radiation - Part 1: Requirements for<br>development, validation, and routine control of a sterilization process for<br>medical devices [Including: Amendment 1 (2013) and Amendment 2 (2019)] |
| ISO 11137-2 | 2013 | Sterilization of health care products - Radiation - Part 2: Establishing the<br>sterilization dose |

#### Table 3 Standards compliance

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A testing has been conducted to substantiate sufficient fatigue endurance limits for the Bonafix 2 Plus Implants for placement in the anterior and posterior regions of the mouth with compatible abutments. Testing has been performed in accordance with ISO 14801:2016 and FDA Class II Special Controls Guidance Document for Root-form Endosseous Dental Implants. The worst-case scenario for the subject devices has demonstrated substantially equivalent to others device legally marketed regard to mechanical performance.

Non-clinical worst-case MRI review was performed to evaluate the metallic Bonafix 2 Plus Implant System 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.

Radiation sterilization validation according to ISO 11137-1 and 11137-2 was provided, demonstrating a sterility assurance level (SAL) of 10-6 and accelerated aging study demonstrating a shelf life of one (5) year.

Steam sterilization validation according to ISO 17665-1 was provided, demonstrating a sterility assurance of sterilization protocol of abutment.

SEM/EDS analysis for worst-case representative implant body was conducted on the subject devices to assess the presence of residual blast media particles on the device due to the modification of the surface treatment in the subject device. SEM/EDS analysis has demonstrated that after the surface treatment the implant doesn't have any different components than Titanium alloy ASTM F 136.

Biocompatibility assessment of the final finished device per recommendations of current FDA guidance (issued on September 4, 2020) in accordance to "ISO 10993-1, Biological evaluation of medical device - Part 1: Evaluation and testing within a risk management process" has been conducted. It is concluded that the Bonafix 2 plus Implants are substantially equivalent to the predicate devices in terms of biocompatibility inclusive of base materials, manufacturing processes inclusive of surface treatments.

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 to be 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. This test will be conducted on every batch. The subject devices will not be labeled as non-pyrogenic or pyrogen-free, nor will any claims be made in regards to non-pyrogenicity.

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## Clinical Testing Summary

Clinical testing was not required to demonstrate the substantial equivalence of the Bonafix 2 Plus to its predicate device.

## Conclusion

Based on the information presented in these 510(k) premarket notifications the Bonafix 2 Plus is considered substantially equivalent (as safe, as effective and performs as well as) to the currently marketed and referenced devices: K191443, MSDI Dental Implants System and Neodent Implant System (K191191), citied in this submission. The differences noted between the Bonafix 2 Plus and the predicate device do not impact safety or effectiveness based on the successfully conducted testing of the subject device.