BBX1, BBX2, BBX1MO, BBX1MC

K142846 · Globaldental, Inc. · DZE · Sep 8, 2016 · Dental

Device Facts

• Record ID: K142846
• Device Name: BBX1, BBX2, BBX1MO, BBX1MC
• Applicant: Globaldental, Inc.
• Product Code: DZE · Dental
• Decision Date: Sep 8, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BBX1, BBX2, BBX1MO, BBX1MC dental implants are intended for immediate loading in the bone of the maxillary or mandibular arch when optimal primary stability is achieved and appropriate occlusal loading. It is intended for use as support of crown bridges and overdentures when a one stage surgical approach is applied. It is intended for the restoration of a patient's chewing function.

Device Story

Endosseous dental implants (BBX1, BBX2, BBX1MO, BBX1MC) designed for surgical placement in maxillary or mandibular bone; support crown bridges and overdentures; restore chewing function. BBX1/MO/MC are one-piece designs; BBX2 is a two-piece system (implant body, screw, straight abutment). Implants feature self-tapping threads with longitudinal/axial grooves extending full length. Fabricated from Titanium Grade 5 ELI (ASTM F-136); surface treated via air blasting with Biphasic Calcium Phosphate/HA microparticles and acid passivation. Used by dental clinicians in surgical settings. Output is a stable foundation for prosthetic restoration. Benefits include permanent tooth replacement and improved masticatory function.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993-5; sterilization validation per ISO 11137-2 and ISO 17665-1; material/surface testing per ASTM F-136, F1185-03, F1088, F-86, F88, F1929, F2096, and F1140.

Technological Characteristics

Material: Titanium Grade 5 ELI (ASTM F-136). Surface: Air blasted with Biphasic Calcium Phosphate/HA (ASTM F1088, F1185-03), acid passivated (ASTM F-86). Design: Threaded, self-tapping with longitudinal/axial grooves. BBX1/MO/MC: One-piece. BBX2: Two-piece (implant, screw, straight abutment). Sterilization: Gamma radiation.

Indications for Use

Indicated for patients requiring dental implants for support of crown bridges and overdentures in the maxillary or mandibular arch, including immediate loading when optimal primary stability and appropriate occlusal loading are 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

• ISI One-Piece Dental Implant (K033392)
• TSI Two-Piece Dental Implant (K090174)

Reference Devices

• Inclusive Mini Implants (K100932)
• MII Implant (K081653)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 8, 2016

Globaldental, Inc. Ebless V. Baez Alers, DMD CEO San Antonio Drama St. 2067 Ponce, PR 00728

Re: K142846

Trade/Device Name: BBX1, BBX2, BBX1MO, BBX1MC Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: July 25, 2016 Received: July 26, 2016

Dear Ebless V. Baez Alers:

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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K151987

Device Name

BBX1, BBX2, BBX1MO, BBX1MC

#### Indications for Use (Describe)

BBX1, BBX2, BBX1MC dental implants are intended for immediate loading in the bone of the maxillary or mandibular arch when optimal primary stability is achieved and appropriate occlusal loading. It is intended for use as support of crown bridges and overdentures when a one stage surgical approach is applied. It is intended for the restoration of a patient's chewing function.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|---------------------------------------------|
| <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/0 description: The image shows the logo for GLOBALDENTAL INC. The logo consists of a circle that is split into two halves, with the left half being yellow and the right half being blue. There is a white line that runs horizontally through the center of the circle, and the text "GLOBALDENTAL INC." is written in blue to the right of the circle.

# K142846 510(k) Summary

# ADMINISTRATIVE INFORMATION

| Manufacturer Name: | GLOBALDENTAL, INC. |
|-----------------------|---------------------------------|
| | Urb. San Antonio Drama St #2067 |
| | Ponce P.R. 00728 |
| | Phone: [phone] |
| | Email: [e-mail] |
| Official Contact: | Ebless V. Baez Alers, DMD |
| | CEO - Globaldental, Inc. |
| | Tel. [phone] |
| | Email: [e-mail] |
| Date Prepared: | September 8, 2016 |
| Proprietary Name: | BBX1, BBX2, BBX1MO, BBX1MC |
| Common Name: | Implant, Endosseous, Root Form |
| Classification Name: | Endosseous Dental Implant |
| Product Code: | DZE, NHA |
| Regulation Number: | 21 CFR 872.3640 |
| DEVICE Class: | II |
| Classification Panel: | Dental |

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### INTENDED USE

BBX1, BBX2, BBX1MO, BBX1MC dental implants are intended for immediate loading in the bone of the maxillary or mandibular arch when optimal primary stability is achieved and appropriate occlusal loading. It is intended for use as support of crown bridges and overdentures when a one stage surgical approach is applied. It is intended for the restoration of a patient's chewing function.

## INTRODUCTION

BBX1, BBX2, BBX1MO, BBX1MC dental implants are similar to the predicate ISI One-Piece Dental Implant from OCO Biomedical, K 033392 and predicate TSI Two-Piece Dental Implant from OCO Biomedical, K 090174. The BBX1, BBX2, BBX1MO and BBX1MC dental implant series features secondary threads which have various longitudinal and axial grooves starting from apical tip and finishing up to the full primary thread length. These axial grooves are called secondary threads or helix threads. The dental implant diameter limits the depth of these longitudinal and axial grooves.

### DEVICE DESCRIPTION

BBX1, BBX1MO, BBX1MC and BBX2 dental implants whose material composition of the implants is titanium alloy Grade 5 ELI (Titanium 6 AL 4V), conforming to ASTM F-136 (Stundard Specification for Wrought Titanium-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). Surface treatment features include air blasting with Biphasic Calcium Phosphate (CaPO4) and HA micro particles, followed by acid passivation and cleaning, conforming to ASTM F1088 Surface Treatment HA, ASTM F-86 (Passivation), and ASTM F1185-03 Trace Elements.

BBX1, BBX1MQ, BBX1MC and BBX2 dental implants are all provided with screw thread and helix shape inclined grooves. For dental implant series BBX1, BBX1MC, the shoulder or abutment is integrated, that is, not a separate part of the whole implant. They are one piece dental implants.

Dental implants series BBX2 consists of three parts, one straight abutment, one screw and the implant body.

BBX1, BBX2, BBX1MO and BBX1MC dental implants consist of a threaded area, a transgingival area, mini threads, an implant body area and a vertical abutment. Additional device description features are shown in the Comparison Chart below.

## EQUIVALENCE TO MARKETED DEVICE

### BBX1, BBX1MO and BBX1MC:

Primary Predicate - OCO Biomedical ISI one piece dental implants (K033392)

Reference devices - K100932 and K081653

### BBX2:

Primary Predicate - OCO Biomedical TSI two piece straight abutment dental implants (K090174)

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# DEVICE COMPARISON CHART:

| | Subject device | Predicate device | Predicate device | Predicate device | | Subject Device | Predicate Device |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) number | K142846 | K033392 | K 100932 | K 081653 | 510(K) number | K142846 | K090174 |
| Device name | BBX1, BBX1MO, BBX1MC<br>(one piece) | ISI- one piece | Inclusive ® Mini Implants | MII Implant | Device name | BBX2 (two piece) | TSI Oco-Biomedical (two piece) |
| Manufacturer | Globaldental, Inc. | OCO-Biomedical, Inc. | Prismatic | IMTEC | Manufacturer | Globaldental, Inc. | Oco-Biomedical, Inc. |
| Indication for use | BBX1, BBX2, BBX1MO,<br>BBX1MC dental implants are<br>intended for immediate loading<br>in the bone of the maxillary or<br>mandibular arch when optimal<br>primary stability is achieved<br>and appropriate occlusal<br>loading. It is intended for use<br>as support of crown bridges<br>and overdentures when a one<br>stage surgical approach is<br>applied. It is intended for the<br>restoration of a patient's<br>chewing function. | The Immediate Stabilizing<br>Implant (ISI) is a one-piece<br>threaded dental implant<br>with the abutment<br>incorporated into the design<br>for a single stage surgical<br>procedure. The implant is<br>intended to be surgically<br>placed in the bone of the<br>upper or lower jaw arches<br>providing support for<br>prosthetic devices resulting<br>in the restoration of the<br>patient's chewing function.<br>Immediate loading can be<br>obtained if implants are<br>rigidly splinted. | Inclusive ® Mini Implants<br>are set tapping threaded<br>titanium screws indicated for<br>long-term applications.<br>Inclusive ® Mini Implants<br>may also be used for<br>provisional applications. These devices will allow immediate<br>loading and long- term<br>stabilization of dentures and<br>provisional stabilization of<br>dentures while standard<br>implants heal. To be used for<br>immediate loading only in the<br>presence of primary stability<br>and appropriate occlusal<br>loading. | The MII Implant is intended<br>to support single or multi-<br>unit restorations in both<br>long-term and temporary<br>applications throughout the<br>maxillary and mandibular arches. The MII Implants is<br>indicated for immediate<br>loading when good primary<br>stability is achieved.<br>Additionally, this device<br>will permit stability and<br>long-term fixation of upper<br>and lower dentures. | Indication for use | BBX1, BBX2, BBX1MO, BBX1MC<br>dental implants are intended for immediate<br>loading in the bone of the maxillary or<br>mandibular arch when optimal primary<br>stability is achieved and appropriate<br>occlusal loading. It is intended for use as<br>support of crown bridges and overdentures<br>when a one stage surgical approach is<br>applied. It is intended for the restoration<br>of a patient's chewing function | The TSI -and ERI Dental<br>Implants are artificial root structures<br>intended for permanent surgical<br>implantation in the bone for the<br>purpose of single or multiple tooth<br>replacements (splinted or free<br>standing), or for stabilization of a<br>prosthetic system, such as artificial<br>teeth in order to restore the patient's<br>chewing function. |
| Design | Non-Submerged Implant<br>Design | Non-Submerged Implant<br>Design | Non-Submerged Implant | Non-Submerged Implant | Design | Non-submerged implant design | Submerged implant design |
| Implant Sterile | Yes | Yes | Yes | Yes | Implant Sterile | Yes | Yes |
| Sterilization Method | Gamma | Gamma | Gamma | Gamma | Sterilization method | Gamma radiation | Gamma radiation |
| Surface Treatment | Ha/Calcium B-TCP-<br>Bisphosphate,RBM | SLA | Blasted Etched Surface, SE to<br>IMTEC K031106 | Blasted and clean (SLA<br>equivalent), machined | Surface treatment | Biphasic Calcium Phosphate<br>Air blasted, passivation | SLA |
| BBXMO, BBXMC<br>Diameter and length<br>combination | 3 mm x 8mm<br>2.2, 2.5, 2.9, 3 mm x 10 mm | 2.2, 2.5, 2.9, 3 mm x 12 mm<br>2.2, 2.5, 2.9, 3 mm x 14 mm | 2.2, 2.5, 2,9, 3 mm x 16 mm | | BBX2 Implant Diameter<br>and length Combinations | 3.25, 4, 5 mm x 8 mm<br>3.25, 4, 5 mm x 10 mm<br>3.25, 4, 5 mm x 12 mm<br>3.25, 4, 5 mm x 14 mm | 3.25, 4, 5 mm x 16 mm |
| BBX1 Diameter and<br>length combinations | 3, 4 and 5 mm x 8 mm<br>3, 4 and 5 mm x 10 mm | 3, 4 and 5 mm x 12 mm<br>3, 4 and 5 mm x 14 mm | 3, 4 and 5 mm x 16 mm | | Implant diameter | 3.25, 4, 5 mm | 3.25, 4, 5 mm |
| Predicate Implant<br>Diameters | N/A | 3.25, 4, 5 mm | 2.2, 2.5, 3.0 mm | 2.9 mm | Implant length | 8, 10, 12, 14, 16 | 8, 10, 12, 14, 16 |
| Predicate<br>Implant Lengths | N/A | 8, 10, 12, 14, 16 mm | 10, 13, 15 mm | 10, 13, 15, 18 mm | Abutment length | 4.0, 5, 7 mm | 2, 3, 4, 5, 5.5, 7 mm |
| Abutment Diameters | 3.0, 3.7 mm | 3.0, 3.7 mm | 1.65 mm | 1.65 mm | Abutment diameter (platform) | 3.7, 4.7, 5.7mm | 3, 4, 5 mm |
| Abutment Length | 4.0 , 5.5 mm | OB-4.0, CB-5.5 | 4.0 mm | 4.0 mm | Attachment | Straight abutments and<br>Components | Angular and straight<br>Abutments |
| Attachments | Straight Abutments- and<br>components | Various abutments, and<br>components | Various abutments, and<br>components | Various abutments, and<br>components. | Packaging | Tyvek, Ultem | Tyvek, Ultem |
| Implant Materials | Ti-6Al-4V ELI, ASTM F-136 | Ti-6Al-4V ELI ASTM F-<br>136 | Ti-6Al-4V ELI ASTM F-<br>136 | Ti-6Al-4V ELI ASTM F-<br>136 | Implant material | Grade 5 titanium alloy<br>(Ti6Al4V) ELI ASTM F-136 | Grade 5 titanium alloy<br>(Ti6Al4V) ELI ASTM F-136 |
| Cover Screw<br>Material | Ti-6Al-4V ELI, ASTM 136 | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Cover screw material | Gr.5 Ti6Al4V ELI | Grade 5 Ti6A14V ELI |
| Product Code | DZE, NHA | DZE | DZE | DZE | Product code | DZE, NHA | DZE |

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BBX1, BBX2, BBX1MO and BBX1MC have similarities to the predicate devices of ISI (K033392) and TSI (K090174) from OCO-Biomedical, Inc. Although the Indications for Use language differs between the wbject and predicate devices, they all share the same intended use, which is a permanent dental implant placement in the bone of the maxillary or mandibular arch. Both are self-tapping implants. The subject devices and predicates have the same operating principles, are made from the same materials and have similar packaging and sterilization process.

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A primary technological difference between the proposed and primary predicate devices is that the proposed device is available in certain diameter and length combinations not featured in the primary predicate device. To demonstrate the substantial equivalence of the proposed device, reference devices K100932 and K081653 were introduced, such that equivalent implant diameter and length combinations complemented those featured in the proposed device, thereby supporting the substantial equivalence of the proposed device to its predicates.

A second difference between the proposed and predicate devices is the fact that self-cutting grooves travel the entire length of the proposed device, whereas the predicate devices feature grooves only in the apical portion. However, the dental implant diameter dictates the depth of the longitudinal grooves, thereby avoiding a new worst-case scenario in the proposed implant. BX1, BX1MO and BBX1MC are substantially equivalent to the OCO-biomedical implant predicate K033392. They are manufactured using Titanium Grade 5 metal alloy ELI, one-piece component, meaning that the abutment and implant portions are combined and fully integrated (no connection).

BBX2. which is atwo-component dental implant is substantially equivalent to the TSI Two-piece dental implant from Oco Biomedical implant K090174. The material is Ti Grade 5 ELI Ti6A1-4V.

## PERFORMANCE DATA

## Nonclinical Testing

The subject device features technological characteristics previously cleared in other devices. Biocompatibility testing was completed in accordance with the requirements of ISO 10993-5, Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing within a Risk Management Process for a permanent implant device with tissue/bone contact. We have conducted every phase under the ASTM-F-136 standards and blasted them with HA/B-TCP BIPHASIC CALCIUM PHOSPHATE. Fatigue testing was not conducted since no angled abutments are included in the subject device system.

Non-clinical testing was performed in accordance to the following:

- . ISO 10993-5 Biological Evaluation of Medical Devices - Cytotoxicity
- ISO 11137-2-2006 Sterilization ●
- ISO 17665-1 moist heat sterilization validation
- ASTM F1185-03 - trace elements
- ASTM F-136 material Ti6A-4V ELI
- ASTM F1088 Standard for Beta TCP
- ASTM F88, F1929, F2096 and F1140 ●

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# CONCLUSION

The subject device and the predicate devices have intended use, have similar technological characteristics, and are made of similar materials. The subject devices encompass the same range of physical dimensions, including diameter and length of the implants, and diameter, height and angle of the abutments. The subject and predicate devices are packaged in similar materials and sterilized using similar methods. Any differences in the technological characteristics do not raise new concerns.

The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.