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 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.

AI/ML Overview

This document describes a 510(k) premarket notification for dental implants (BBX1, BBX2, BBX1MO, BBX1MC). As such, it focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance data as would be typically seen for a novel device or software. Therefore, much of the requested information regarding acceptance criteria, specific device performance, sample sizes for test and training sets, expert qualifications, adjudication, MRMC studies, standalone performance, and ground truth establishment is not present in this type of regulatory submission.

However, based on the provided text, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of acceptance criteria with specific performance metrics (e.g., accuracy, sensitivity, specificity) for new clinical outcomes. Instead, it demonstrates "substantial equivalence" to predicate devices by comparing various characteristics. The "performance" assessment is based on non-clinical testing to ensure fundamental safety and material requirements are met, and that the new device's characteristics do not raise new safety or effectiveness concerns compared to existing devices.

Characteristic Compared	Acceptance Criteria (Implied)	Reported Device Performance (vs. Predicates)
Intended Use	Same as predicate devices	Met: "same intended use"
Operating Principles	Same as predicate devices	Met: "same operating principles"
Materials	Similar to predicate devices	Met: "made from the same materials (titanium alloy Grade 5 ELI, conforming to ASTM F-136)"
Packaging	Similar to predicate devices	Met: "packaged in similar materials (Tyvek, Ultem)"
Sterilization Method	Similar to predicate devices	Met: "sterilized using similar methods (Gamma radiation)"
Physical Dimensions	Encompasses same range as predicate devices	Met: "encompass the same range of physical dimensions, including diameter and length of the implants, and diameter, height and angle of the abutments"
Biocompatibility	Conforms to ISO 10993-5	Met: "completed in accordance with ISO 10993-5"
Material Standards	Conforms to ASTM F-136	Met: "conforming to ASTM F-136"
Surface Treatment	Conforms to ASTM standards	Met: "conforming to ASTM F1088 Surface Treatment HA, ASTM F-86 (Passivation), and ASTM F1185-03 Trace Elements"
Fatigue Testing	Not required (implied) for subject device	Not Applicable: "Fatigue testing was not conducted since no angled abutments are included in the subject device system."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: Not applicable in the context of this 510(k) submission. There is no specific "test set" of patient data or clinical cases described for evaluating new clinical performance metrics. The demonstration of substantial equivalence relies on non-clinical testing and comparison to existing predicate devices.
Data Provenance: The data provided is primarily technical and regulatory documentation comparing the subject device to predicate devices and demonstrating compliance with various ASTM and ISO standards for materials, manufacturing, and biocompatibility. There is no mention of country of origin for clinical data or whether it is retrospective or prospective, as clinical trials were not part of this submission for substantial equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Number of Experts: Not applicable. As there is no clinical "test set" with clinical outcomes that require expert ground truth establishment, no experts were utilized for this purpose in the context of this regulatory submission.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. No clinical "test set" requiring adjudication of results is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

MRMC Study: No. This device is a dental implant, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not relevant to this submission.
Effect Size of Human Readers with/without AI: Not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Standalone Performance: Not applicable. This device is a physical medical device (dental implant), not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

Type of Ground Truth: For the non-clinical testing, the "ground truth" is defined by established international and national standards (e.g., ISO 10993-5 for biocompatibility, ASTM F-136 for material composition and properties). Compliance with these standards serves as the "ground truth" for the device's fundamental safety and material characteristics. No clinical outcomes data for a novel device/AI application is mentioned as ground truth.

8. The Sample Size for the Training Set:

Sample Size for Training Set: Not applicable. There is no "training set" in the context of this 510(k) submission for dental implants. This is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established:

Ground Truth for Training Set Establishment: Not applicable.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Image /page/1/Picture/8 description: The image shows a signature followed by the name "Tina Kiang". Below the name is the character sequence "-s". The signature is complex and illegible.

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)
X 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: 1787.844.02331
	Email: info@novobiotek.com
Official Contact:	Ebless V. Baez Alers, DMD
	CEO - Globaldental, Inc.
	Tel. 787-844-0345
	Email: fda@novobiotek.com
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

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

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(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,BBX1MC dental implants areintended for immediate loadingin the bone of the maxillary ormandibular arch when optimalprimary stability is achievedand appropriate occlusalloading. It is intended for useas support of crown bridgesand overdentures when a onestage surgical approach isapplied. It is intended for therestoration of a patient'schewing function.	The Immediate StabilizingImplant (ISI) is a one-piecethreaded dental implantwith the abutmentincorporated into the designfor a single stage surgicalprocedure. The implant isintended to be surgicallyplaced in the bone of theupper or lower jaw archesproviding support forprosthetic devices resultingin the restoration of thepatient's chewing function.Immediate loading can beobtained if implants arerigidly splinted.	Inclusive ® Mini Implantsare set tapping threadedtitanium screws indicated forlong-term applications.Inclusive ® Mini Implantsmay also be used forprovisional applications. These devices will allow immediateloading and long- termstabilization of dentures andprovisional stabilization ofdentures while standardimplants heal. To be used forimmediate loading only in thepresence of primary stabilityand appropriate occlusalloading.	The MII Implant is intendedto support single or multi-unit restorations in bothlong-term and temporaryapplications throughout themaxillary and mandibular arches. The MII Implants isindicated for immediateloading when good primarystability is achieved.Additionally, this devicewill permit stability andlong-term fixation of upperand lower dentures.	Indication for use	BBX1, BBX2, BBX1MO, BBX1MCdental implants are intended for immediateloading in the bone of the maxillary ormandibular arch when optimal primarystability is achieved and appropriateocclusal loading. It is intended for use assupport of crown bridges and overdentureswhen a one stage surgical approach isapplied. It is intended for the restorationof a patient's chewing function	The TSI -and ERI DentalImplants are artificial root structuresintended for permanent surgicalimplantation in the bone for thepurpose of single or multiple toothreplacements (splinted or freestanding), or for stabilization of aprosthetic system, such as artificialteeth in order to restore the patient'schewing function.
Design	Non-Submerged ImplantDesign	Non-Submerged ImplantDesign	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-Bisphosphate,RBM	SLA	Blasted Etched Surface, SE toIMTEC K031106	Blasted and clean (SLAequivalent), machined	Surface treatment	Biphasic Calcium PhosphateAir blasted, passivation	SLA
BBXMO, BBXMCDiameter and lengthcombination	3 mm x 8mm2.2, 2.5, 2.9, 3 mm x 10 mm	2.2, 2.5, 2.9, 3 mm x 12 mm2.2, 2.5, 2.9, 3 mm x 14 mm	2.2, 2.5, 2,9, 3 mm x 16 mm		BBX2 Implant Diameterand length Combinations	3.25, 4, 5 mm x 8 mm3.25, 4, 5 mm x 10 mm3.25, 4, 5 mm x 12 mm3.25, 4, 5 mm x 14 mm	3.25, 4, 5 mm x 16 mm
BBX1 Diameter andlength combinations	3, 4 and 5 mm x 8 mm3, 4 and 5 mm x 10 mm	3, 4 and 5 mm x 12 mm3, 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 ImplantDiameters	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
PredicateImplant 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 andComponents	Angular and straightAbutments
Attachments	Straight Abutments- andcomponents	Various abutments, andcomponents	Various abutments, andcomponents	Various abutments, andcomponents.	Packaging	Tyvek, Ultem	Tyvek, Ultem
Implant Materials	Ti-6Al-4V ELI, ASTM F-136	Ti-6Al-4V ELI ASTM F-136	Ti-6Al-4V ELI ASTM F-136	Ti-6Al-4V ELI ASTM F-136	Implant material	Grade 5 titanium alloy(Ti6Al4V) ELI ASTM F-136	Grade 5 titanium alloy(Ti6Al4V) ELI ASTM F-136
Cover ScrewMaterial	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.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
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.(b)
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.