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.

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 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.

AI/ML Overview

The provided text describes a 510(k) submission for a dental implant device called "MiniFix Implant". It details the device's description, intended use, and a comparison to predicate devices, but does not contain information about acceptance criteria or specific studies proving the device meets those criteria in the context of performance metrics like accuracy, sensitivity, or specificity.

The submission focuses on establishing substantial equivalence to existing predicate devices (MDI MII One-Piece Implant 2.9mm, Inclusive Mini Implant, and Mini Drive-Lock Dental Implant System) based on materials, design, surface treatment, fatigue testing, and risk management. The "Non-Clinical Test Data" section explicitly states: "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." This indicates that the regulatory approval relies on the similarity to already approved devices rather than new performance studies with acceptance criteria for the device itself.

Therefore, I cannot provide the requested information. The document does not describe:

A table of acceptance criteria and the reported device performance: No such criteria or performance data is presented in the context of study outcomes.
Sample size used for the test set and the data provenance: There is no test set described for performance evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there's no performance test set.
Adjudication method: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

The document is a regulatory submission for a medical device seeking substantial equivalence, not a report on a performance study with detailed clinical or non-clinical evaluation metrics and acceptance criteria.

Summary

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K122052

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SECTION 3

510(k) Summary

NOV 2 8 2012

Device Name:	MiniFix Implant
Date Prepared:	July 2, 2012
Sponsor:	BONAFIX Surgical and Dental Implants, LLC118 W Prive Cr.Delray Beach Fl, 33445
Contact:	Juan TezakJuan@Bonafixsdi.com(561) 789-2411
Device andClassificationName	Device Trade Name: MiniFix ImplantCommon 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)

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KI22052

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Device Description:

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

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K122052

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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.

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

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KI 22052

Page 15 of 152

	Bonafix's MiniFixImplant	IMTEC MDI MIIOne-PieceImplant ,2.9mm	Prismatik'sInclusive MiniImplant	Mini Drive-LockDental ImplantSystem
510kNumber	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
DriverConnection	Square	Square	Square	Square
Housing/O-Ring	Titanium Alloy/EPDM	TitaniumAlloy/EPDM	TitaniumAlloy/EPDM	TitaniumAlloy/EPDM
Indications	The proposed MiniFixImplant system consists ofMiniFix One and MiniFix Ballimplants.The MiniFix One implants areindicated to provide supportfor single unit dentalprostheses in the mandibularcentral and lateral incisor andmaxillary lateral incisorregions of partiallyedentulous jaws. The MiniFixOne implant must be splintedif two or more are usedadjacent to each other. TheMiniFix One implant may beimmediately restored with atemporary prosthesis that isnot in functional occlusion.The MiniFix Ball implants areintended to be placedthroughout the maxillary andmandibular arches to providesupport for multi-unitrestorations on long-term orshort term fixation of upperand lower dentures.Immediate loading shouldonly be done in the presenceof primary stability andappropriate occlusal loading.	The MII Implant isintended to supportsingle unit or multi-unitrestorations in bothlong-term andtemporary applicationsthroughout themaxillary andmandibular arches. TheMII Implant is indicatedfor immediate loadingwhen good primarystability is achieved.Additionally this devicepermit stability andlong term fixation ofupper and lowerdentures in edentulouscases	Inclusive Mini Implantsare self-tapping threadedtitanium screws indicatedfor long term applications.Inclusive Mini Implantsmay also be used forprovisional applications.These devices will allowimmediate loading andlong-term stabilization ofdentures and provisionalstabilization of dentureswhile standard implantsheal. To be used forimmediate loading only inthe presence of primarystability and appropriateocclusal loading.	Mini Drive-Lock TMDental Implants areintended for use as a self-tappingtitanium screw fortransitional or intra-bonylong-term applications.Mini Drive-Lock TMDental Implants areindicated for long-termmaxillaryand mandibular tissue-supported denturestabilization. Multipleimplantsshould be used and maybe restored after a periodof time or placed inimmediate function.

মি

additional details on the equivalence of the three devices.

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K 12205 d

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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.

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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.

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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

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Page 11 of 152

Indications for Use

510(k) Number (if known):

Device Name: MiniFix Implant

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 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.

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:

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.