K Number

Device Name

BBX1, BBX2, BBX1MO, BBX1MC

Manufacturer

GLOBALDENTAL, INC.

Date Cleared

2016-09-08

(709 days)

Product Code

DZE NHA

Regulation Number

872.3640

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 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K033392, K090174

Reference Devices

K100932, K081653

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical dental implant made of titanium alloy with specific surface treatments and structural features. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.

Therapeutic

Yes
The device is a dental implant intended to restore a patient's chewing function, which is a therapeutic purpose.

Diagnostic

Explanation: The device is a dental implant intended to restore chewing function and support crowns, bridges, and overdentures. Its purpose is therapeutic rather than diagnostic.

SaMD (Software as a Medical Device)

The device description clearly states the device is a dental implant made of titanium alloy, which is a physical hardware component.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the dental implants are for surgical implantation into bone to support dental prosthetics and restore chewing function. This is a therapeutic and structural purpose, not a diagnostic one.
Device Description: The description details the physical characteristics, materials, and components of a dental implant, which is a medical device used in surgery.
Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Performance Studies: The performance studies focus on biocompatibility and sterilization, which are relevant to implanted medical devices, not IVDs.

IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This dental implant does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

DZE, NHA

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

maxillary or mandibular arch

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 ●

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K033392, K090174

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K100932, K081653

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing right, layered on top of each other, with a flowing ribbon-like element extending from the bottom profile.

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.

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

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

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.

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)

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 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.	The Immediate Stabilizing
Implant (ISI) is a one-piece
threaded dental implant
with the abutment
incorporated into the design
for a single stage surgical
procedure. The implant is
intended to be surgically
placed in the bone of the
upper or lower jaw arches
providing support for
prosthetic devices resulting
in the restoration of the
patient's chewing function.
Immediate loading can be
obtained if implants are
rigidly splinted.	Inclusive ® Mini Implants
are set tapping threaded
titanium screws indicated for
long-term applications.
Inclusive ® Mini Implants
may also be used for
provisional applications. These devices will allow immediate
loading and long- term
stabilization of dentures and
provisional stabilization of
dentures while standard
implants heal. To be used for
immediate loading only in the
presence of primary stability
and appropriate occlusal
loading.	The MII Implant is intended
to support single or multi-
unit restorations in both
long-term and temporary
applications throughout the
maxillary and mandibular arches. The MII Implants is
indicated for immediate
loading when good primary
stability is achieved.
Additionally, this device
will permit stability and
long-term fixation of upper
and lower dentures.	Indication for 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	The TSI -and ERI Dental
Implants are artificial root structures
intended for permanent surgical
implantation in the bone for the
purpose of single or multiple tooth
replacements (splinted or free
standing), or for stabilization of a
prosthetic system, such as artificial
teeth in order to restore the patient's
chewing function.
Design	Non-Submerged Implant
Design	Non-Submerged Implant
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-
Bisphosphate,RBM	SLA	Blasted Etched Surface, SE to
IMTEC K031106	Blasted and clean (SLA
equivalent), machined	Surface treatment	Biphasic Calcium Phosphate
Air blasted, passivation	SLA
BBXMO, BBXMC
Diameter and length
combination	3 mm x 8mm
2.2, 2.5, 2.9, 3 mm x 10 mm	2.2, 2.5, 2.9, 3 mm x 12 mm
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
and length Combinations	3.25, 4, 5 mm x 8 mm
3.25, 4, 5 mm x 10 mm
3.25, 4, 5 mm x 12 mm
3.25, 4, 5 mm x 14 mm	3.25, 4, 5 mm x 16 mm
BBX1 Diameter and
length combinations	3, 4 and 5 mm x 8 mm
3, 4 and 5 mm x 10 mm	3, 4 and 5 mm x 12 mm
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
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
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
Components	Angular and straight
Abutments
Attachments	Straight Abutments- and
components	Various abutments, and
components	Various abutments, and
components	Various abutments, and
components.	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 Screw
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

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.

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 ●

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.