Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a physical dental implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.

Therapeutic

Yes
The device is a dental implant system used to provide support for dental prostheses and restorations, directly treating a medical condition (edentulous jaws).

Diagnostic

No

The device is an implant system designed to provide support for dental prostheses and multi-unit restorations, not to diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states the device is a physical implant made of titanium alloy, designed for surgical placement. It is a hardware device, not software.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Description: The MiniFix Implant system is a physical implant designed to be surgically placed in the jawbone to support dental prostheses. It is a medical device used in vivo (within the body), not in vitro (in a test tube or lab setting).
Intended Use: The intended use is to provide support for dental prostheses in the mouth, which is a surgical and restorative procedure, not a diagnostic test.

Therefore, the MiniFix Implant system falls under the category of a surgical dental implant, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The proposed MiniFix Implant system consists of MiniFix One and MiniFix Ball implants.

The MiniFix One implants are indicated to provide support for single unit dental prostheses in the mandibular central and lateral incisor and maxillary lateral incisor regions of partially edentulous jaws. The MiniFix One implant must be splinted if two or more are used adjacent to each other. The MiniFix One implant may be immediately restored with a temporary prosthesis that is not in functional occlusion.

The MiniFix Ball implants are intended to be placed throughout the maxillary and mandibular arches to provide support for multi-unit restorations on long-term or short term fixation of upper and lower dentures. Immediate loading should only be done in the presence of primary stability and appropriate occlusal loading.

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

NZE, DZE

Device Description

Built in Grade 5 ELI Titanium Alloy and treated with RBM technology, the proposed MiniFix implants are designed for both provisional and permanent implementations of single-unit or multi-unit restorations.

The major component of the MiniFix Implant consists of a one-piece, root-form, self-tapping screw. This implant is offered in two models, each with its own applicability: MiniFix Ball and MiniFix One.

The MiniFix Ball implant provides a spherical head that allows for easy placement and removal of both partial and full dentures. Additionally, this model is available in an option without the RBM treatment for use in transitional applications (temporary dentures).

Minifx One is a single piece implant that provides a flat head for permanent installation of single crowns.

The table below shows the available models and sizes for Minifix Ball and Minifix One implants:

Catalog numbers of the Proposed MiniFix Implants
MiniFix Ball
Diameter	Length
(11 mm)	Length
(13 mm)	Length
(15 mm)
2.0	MFB2011L	MFB2013L	MFB2015L
2.4	MFB2411L	MFB2413L	MFB2415L
2.9	MFB2911L	MFB2913L	MFB2915L
MiniFix One
2.9	MFO2911S	MFO2913S	MFO2915S
Transitional MiniFix Ball (No surface treatment)
2.0	MFBT2011L	MFBT2013L	MFBT2015L
2.4	MFBT2411L	MFBT2413L	MFBT2415L
2.9	MFBT2911L	MFBT2913L	MFBT2915L

As shown on the table, Minifix Ball is available in the same 9 sizes for both Transitional and Permanent implants while the square Minifix One is available for 11, 13 and 15 mm 2.9mm. a single diameter at lengths but with

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

mandibular central and lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, maxillary and mandibular arches

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)

Not Found

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.

K081653, K100932, K070601

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.

Not Found

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

0

K122052

Page 12 of 152

SECTION 3

510(k) Summary

NOV 2 8 2012

Device Name:	MiniFix Implant
Date Prepared:	July 2, 2012
Sponsor:	BONAFIX Surgical and Dental Implants, LLC
118 W Prive Cr.
Delray Beach Fl, 33445
Contact:	Juan Tezak
Juan@Bonafixsdi.com
(561) 789-2411
Device and
Classification
Name	Device Trade Name: MiniFix Implant
Common Name: Endosseous dental implant

Classification Regulation: 21 CFR 872.3640 .
Classification Name: Implant, Endosseous,Root-form .
Device Classification: Class II .
Classification Panel: Dental ●
Product Code: NZE .

.

Predicate Devices:

(reference 510(k) K081653, determined substantially equivalent on September 19th, 2008)
MDI MII One-Piece Implant 2.9mm; Imtec Corp.(USA) -
Inclusive Mini Implant; Prismatik Dentalcraft, Inc. (USA) . - (reference 510(k) K100932, determined substantially equivalent December 27, 2010.
Mini Drive-Lock Dental Implant System; Intra-Lock . International (USA) - (reference 510(k) K070601, determined substantially equivalent October 12, 2007)

Ax

1

KI22052

Page 13 of 152

Device Description:

Hx

Built in Grade 5 ELI Titanium Alloy and treated with RBM technology, the proposed MiniFix implants are designed for both provisional and permanent implementations of singleunit or multi-unit restorations.

The major component of the MiniFix Implant consists of a one-piece, root-form, self-tapping screw. This implant is offered in two models, each with its own applicability: MiniFix Ball and MiniFix One ..

The MiniFix Ball implant provides a spherical head that allows for easy placement and removal of both partial and full dentures. Additionally, this model is available in an option without the RBM treatment for use in transitional applications (temporary dentures).

Minifx One is a single piece implant that provides a flat head for permanent installation of single crowns.

The table below shows the available models and sizes for Minifix Ball and Minifix One implants:

Catalog numbers of the Proposed MiniFix Implants
MiniFix Ball
Diameter	Length
(11 mm)	Length
(13 mm)	Length
(15 mm)
2.0	MFB2011L	MFB2013L	MFB2015L
2.4	MFB2411L	MFB2413L	MFB2415L
2.9	MFB2911L	MFB2913L	MFB2915L
MiniFix One
2.9	MFO2911S	MFO2913S	MFO2915S
Transitional MiniFix Ball (No surface treatment)
2.0	MFBT2011L	MFBT2013L	MFBT2015L
2.4	MFBT2411L	MFBT2413L	MFBT2415L
2.9	MFBT2911L	MFBT2913L	MFBT2915L

As shown on the table, Minifix Ball is available in the same 9 sizes for both Transitional and Permanent implants while the square Minifix One is available for 11, 13 and 15 mm 2.9mm. a single diameter at lengths but with

2

K122052

Page 14 of 152

Intended Use:

The proposed MiniFix Implant system consists of MiniFix One and MiniFix Ball implants.

· The MiniFix One implants are indicated to provide support for single unit dental prostheses in the mandibular central and lateral incisor and maxillary lateral incisor regions of partially edentulous jaws. The MiniFix One implant must be splinted if two or more are used adjacent to each other. The MiniFix One implant may be immediately restored with a temporary prosthesis that is not in functional occlusion.

The MiniFix Ball implants are intended to be placed throughout the maxillary and mandibular arches to provide support for multi-unit restorations on long-term or short term fixation of upper and lower dentures. Immediate loading should only be done in the presence of primary stability and appropriate occlusal loading.

Non-Clinical Test Data:

Minifx Implants do not introduce new issues for materials, design, surface treatment, fatigue testing and risk management that have not been addressed in all other substantially equivalent predicate devices.

Substantial Equivalence to Predicate Devices:
The proposed MiniFix Implant is substantially equivalent to the MDI MII One-Piece Implant 2.9mm from Imtec Corp., the Inclusive Mini Implant from Prismatik and the Mini Drive-Lock Dental Implant System from Intra-Lock International. All these are single-piece implants manufactured with the same titanium alloy and combine a screw section for implant insertion with an abutment section that supports either a denture application or a permanent crown. All three implants are provided sterile and are intended for use in long term applications as well as in temporary scenarios in which provisional dentures are required to provide time for permanent implants to osseointegrate before installation of crowns. The table that follows provides

3

KI 22052

Page 15 of 152

| | Bonafix's MiniFix
Implant | IMTEC MDI MII
One-Piece
Implant ,2.9mm | Prismatik's
Inclusive Mini
Implant | Mini Drive-Lock
Dental Implant
System |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k
Number | This Submission | K081653 | K100932 | K070601 |
| Composition | Titanium Alloy | Titanium Alloy | Titanium Alloy | Titanium Alloy |
| Diameter
(mm) | 2.0,2.4,2.9 | 2.9 | 2.2, 2.5, 3.0 | 2.0,2.5 |
| Length (mm) | 11,13,15 | 10,13,15,18 | 10,13,15 | 10,11.5,13,15,18 |
| Head | O-Ball, Square | O-Ball, Square | O-Ball | O-Ball |
| Driver
Connection | Square | Square | Square | Square |
| Housing/O-
Ring | Titanium Alloy/EPDM | Titanium
Alloy/EPDM | Titanium
Alloy/EPDM | Titanium
Alloy/EPDM |
| Indications | The proposed MiniFix
Implant system consists of
MiniFix One and MiniFix Ball
implants.

The MiniFix One implants are
indicated to provide support
for single unit dental
prostheses in the mandibular
central and lateral incisor and
maxillary lateral incisor
regions of partially
edentulous jaws. The MiniFix
One implant must be splinted
if two or more are used
adjacent to each other. The
MiniFix One implant may be
immediately restored with a
temporary prosthesis that is
not in functional occlusion.
The MiniFix Ball implants are
intended to be placed
throughout the maxillary and
mandibular arches to provide
support for multi-unit
restorations on long-term or
short term fixation of upper
and lower dentures.
Immediate loading should
only be done in the presence
of primary stability and
appropriate occlusal loading. | The MII Implant is
intended to support
single unit or multi-unit
restorations in both
long-term and
temporary applications
throughout the
maxillary and
mandibular arches. The
MII Implant is indicated
for immediate loading
when good primary
stability is achieved.
Additionally this device
permit stability and
long term fixation of
upper and lower
dentures in edentulous
cases | Inclusive Mini Implants
are self-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. | Mini Drive-Lock TM
Dental Implants are
intended for use as a self-
tapping
titanium screw for
transitional or intra-bony
long-term applications.
Mini Drive-Lock TM
Dental Implants are
indicated for long-term
maxillary
and mandibular tissue-
supported denture
stabilization. Multiple
implants
should be used and may
be restored after a period
of time or placed in
immediate function. |

মি

additional details on the equivalence of the three devices.

4

K 12205 d

Page 16 of 152

Correspondence of predicates to the specific Minifix options are shown in the table below:

| Diameter(mm)/

Lengths(mm)	Equivalent To:
Minifix Ball
2.0 /
11, 13,15	Mini Drive-Lock Dental Implant System 2.0mm
2.4 /
11, 13, 15	Prismatik's Inclusive Mini Implant 2.2mm & 2.5mm
2.9 /
11,13,15	Prismatik's Inclusive Mini Implant 2.5mm & 3.0mm
Minifix One
2.9	IMTEC MDI MII One-Piece Implant 2.9mm

Comparison of

Technological

Differences: There are no known technological differences between the proposed MiniFix Implant and the predicate devices specified in this document.

5

Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. 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 image of an eagle with three wavy lines extending from its body.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-002

November 28, 2012

Mr. Juan Tezak President BONAFIX Surgical and Dental Implants, Limited Liability Company 118 West Prive Circle Delray Beach, Florida 33445

Re: K122052

Trade/Device Name: MiniFix Implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: October 17, 2012 Received: October 17, 2012

Dear Mr. 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. 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 Eederal Register.

6

Page 2 - Mr. Tezak

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 device-related 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

2012.11.28 Susan Runner DDS, MA -1:3:01:38 -05'00'

Anthony D. Watson, B.S., M.S., M.B.A.

Director

Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices

Office of Device Evaluation

Center for Devices and

Radiological Health

Enclosure

7

Page 11 of 152

Indications for Use

510(k) Number (if known):

Device Name: MiniFix Implant

Indications For Use:

Kx

The proposed MiniFix Implant system consists of MiniFix One and MiniFix Ball implants.

The MiniFix One implants are indicated to provide support for single unit dental prostheses in The Milli IX One implants are mencisor and maxillary lateral incisor regions of partially the mandlous jaws. The MiniFix One implant must be splinted if two or more are used adjacent to each other. The MiniFix One implant may be immediately restored with a temporary prosthesis that is not in functional occlusion.

The MiniFix Ball implants are intended to be placed throughout the maxillary and mandibular arches to provide support for multi-unit restorations on long-term or short term fixation of upper and lower dentures. Immediate loading should only be done in the presence of primary stability and appropriate occlusal loading.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

င္းရႈမွၾကုမ္မရာဌမျှင့္ Of ORH, Office of Device Evaluation (ODE) Susan Runner DDS, MA 13:03:11 -05'00'

(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Division Control, Dental Devices

Page 1 of 1

510(k) Number: