A.B.DENTAL DEVICES® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. A.B. DENTAL DEVICES® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Two Stage Implants: 12, 15, 16BI.

One Stage: 16, 16b, 16B.

One Stage & One-Piece 3.0 mm diameter implants: 16, 16B1, are intended for placement at the mandibular central and lateral incisors and maxillary and lateral incisors. Indicated also for denture stabilization using multiple implants.

One stage & One-Piece 2.4 mm diameter implants for temporary use or long term use: 16, 16b, permit immediate splint stability and long term fixation of new or existing crown, bridge and prosthesis.

P14 Angulated Abutment Adapter is to be used with implant diameter 4.2mm and higher.

Device Description

A.B. DENTAL DEVICES® Dental Implants System consists of one and two stage endosseous form dental implants, internal hexagonal and one piece implants system;

l2 - Screw Type Implant - Diameter 3.5, Length 8, 10,11.5,13,16

l5 - Conical Implant - Diameter 3.5, Length 8, 10,11.5,13,16

16 - Narrow Integral Implant - Diameter 2.4, 3, 3.2 Length 10, 11.5, 13, 16

l6b - Ball Attachment Implant - Diameter 2.4 Length 10, 11.5, 13, 16

16B - Narrow Implant - Diameter 3, 3.2 Length 10, 11.5, 13, 16

16BI - Narrow Implant - Diameter 3 Length 10, 11.5, 13, 16

Abutments System consists of healing caps, screws, Anti-rotation Abutment, Anatomic Anti-rotation Abutment, Narrow / Wide Anti-rotation Abutment, Zirconium Anatomic Abutment, Temporary PEEK Anatomic Anti-rotation Abutment, Long Angular Abutment 15°, Anatomic Angular Abutment 15°, Ball Attachment Abutment, Angular Ball Attachment 20°, Ball for Angular Adaptor, Titanium Sleeve, Anti-rotation Aesthetic Abutment, Composed Hex/Non Hex Abutment, Angular Adaptor, Locator and other superstructures; impression copy system & surgical instruments are also provided.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, specifically the "A.B. DENTAL DEVICES® Dental Implants System." This submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study.

Therefore, the document does not contain information about:

A table of acceptance criteria and reported device performance.
Sample sizes used for a test set or data provenance for such a test.
Number of experts, their qualifications, or adjudication methods for establishing ground truth in a test set.
A multi-reader multi-case (MRMC) comparative effectiveness study, nor its effect size.
A standalone (algorithm-only) performance study.
Specific types of ground truth (e.g., pathology, outcomes data) for a test set.
Sample size for a training set.
How ground truth for a training set was established.

Instead, the document focuses on non-clinical testing and substantial equivalence.

Here's what can be extracted:

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing)

The "acceptance criteria" here are compliance with recognized standards and demonstration of properties comparable to predicate devices, rather than performance metrics from a clinical study.

Acceptance Criterion (Standard)	Reported Device Performance
ISO 7405 (Dentistry - Evaluation of biocompatibility of medical devices)	Complied. (Implied by the statement that the device "raises no new issues of safety or effectiveness than the predicate devices" after mentioning risk assessment and substantial equivalence which would encompass biocompatibility.)
ISO 5832-3 (Implants for surgery - Metallic materials - Wrought titanium alloy)	Implants are made of GR-5 Titanium Ti-6Al-4V ELI, which aligns with the standard.
ISO 14801 (Dentistry-Implants-Dynamic fatigue test for endosseous dental implants)	"A.B. DENTAL DEVICES® has conducted Fatigue - Static & Cycling tests which comply with ISO 14801... The test results have demonstrated the high resistance and high ability with the use of A.B. DENTAL DEVICES® Dental Implant System." The submission concludes that this "raises no new issues of safety or effectiveness than the predicate devices."
FDA guidance document: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments	Complied. (Implied by the submission process and subsequent FDA clearance based on substantial equivalence, which assesses compliance with such special controls.)
Substantial Equivalence to Predicate Devices	The submission extensively details how the A.B. DENTAL DEVICES® Dental Implants System is similar or identical to several predicate devices (e.g., M.I.S, Alpha Bio Tec, IMTEC, Nobel Biocare, Biohorizon, Zimmer, Inclusive dental solutions, Zest Anchors) in terms of intended use, indications for use, technological characteristics (materials like GR-5 Titanium Ti-6Al-4V ELI, implant body contour, connection type), performance, and user interface. The conclusion states it "raises no new issues of safety or effectiveness than the predicate devices."

Non-Clinical Study Details:

The study described is not a clinical study with patients, but rather bench testing to demonstrate mechanical performance and a risk assessment to demonstrate safety and effectiveness relative to predicate devices.

Sample size used for the test set and the data provenance: Not explicitly stated for each test, but the testing would have been conducted on representative samples of the A.B. DENTAL DEVICES® Dental Implants System. The provenance is internal to the manufacturer (A.B. DENTAL DEVICES Ltd., ISRAEL). This is retrospective in the sense that it's testing of manufactured devices for regulatory submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical tests is determined by the physical properties and performance against international standards, not expert consensus.
Adjudication method for the test set: Not applicable to mechanical bench testing.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not mentioned.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a physical dental implant system, not a software algorithm.
The type of ground truth used: For mechanical testing, the ground truth is established by the specified parameters and methodologies of the ISO standards (e.g., specific force, cycles, fracture points). For safety and effectiveness, the ground truth is the established safety profile and performance of the predicate devices.
The sample size for the training set: Not applicable, as this is not a machine learning algorithm.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document details a substantial equivalence submission based on compliance with international standards for biocompatibility and mechanical fatigue, along with a comparison of the device's design and materials to legally marketed predicate devices. It does not contain information about clinical trials or performance metrics that would typically be associated with AI or diagnostic device studies.

Summary

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Page 1 of _

SECTION 5.....................................................................................................................................................................

510(k) Number K J 3 2 12 S

1 Submission Owner
Official Correspondent 2 Contact Person
3 Submission Date
4 Device Trade Name
5 Regulation Description
Classification 6

A.B. DENTAL DEVICES Ltd.
19 Hayalomim St.,
Ashdod 77101
ISRAEL
Phone : 972-8-8531388
Fax : 972-8-8522562
Sterling Medical Registration
Daniela Levy - Regulatory Consultant
22817 Ventura blvd. #161
Woodland Hills, CA 91364
Phone: 1-213-787-3026
Fax: 1-213-447-5297
Email Daniela@sterlingmedicalregistration.com
July 7th, 2013
A.B. DENTAL DEVICES ® Dental Implants System
Root-form Endosseous Dental Implants & Abutments
Device Name	: Implant, endosseous, root-form
Product Code	: DZE
Regulation No	: 872.3640
Class	: II
Panel	: Dental
Subsequent Product Code:
Name	: Abutment, implant, dental, endosseous
Product Code	: NHA
Regulation No	: 872.3630
Class	: II
Panel	: Dental

JAN 2 1 2014

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Reason for the Premarket Notification Submission : New Device 7
Identification of Legally Marketed Predicate Devices : 8

A.B. DENTAL DEVICES ® Dental Implants System is substantially equivalent to M.I.S, K092555; Alpha Bio Tec K063364; IMTEC K031106; Nobel Biocare K071370; K102436, K041876; in terms of intended use, indication for use, technological characteristics, performance and user interface.

A.B. DENTAL DEVICES ® Dental Abutments System is substantially equivalent to M.I.S. K040807; Biohorizon K103691; Alpha Bio Tec K063364; Zimmer K052600, K061847. K092377: A.B.Dental Devices K051719, K112440; Nobel Biocare K072570.K093643, K031719, K061529, K091904, K061477; Inclusive dental solutions K083480; Zest Anchors K083324; in terms of intended use, indication for use, technological characteristics, performance and user interface.

The predicate devices are a Class II medical device.

Device Description: 9

A.B. DENTAL DEVICES® Dental Implants System consists of one and two stage endosseous form dental implants, internal hexagonal and one piece implants system;

l2 - Screw Type Implant - Diameter 3.5, Length 8, 10,11.5,13,16

l5 - Conical Implant - Diameter 3.5, Length 8, 10,11.5,13,16

16 - Narrow Integral Implant - Diameter 2.4, 3, 3.2 Length 10, 11.5, 13, 16

l6b - Ball Attachment Implant - Diameter 2.4 Length 10, 11.5, 13, 16

16B - Narrow Implant - Diameter 3, 3.2 Length 10, 11.5, 13, 16

16BI - Narrow Implant - Diameter 3 Length 10, 11.5, 13, 16

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10 Intended use / Indication for Use:

Two Stage Implants: 12, 15, 16BI.

One Stage: 16, 16b, 16B.

One Stage & One-Piece 3.0 mm diameter implants: 16, 16B, 16Bl, are intended for placement at the mandibular central and lateral incisors and maxillary and lateral incisors. Indicated also for denture stabilization using multiple implants.

One stage & One-Piece 2.4 mm diameter implants for temporary use or long term use: 16. 16b, permit immediate splint stability and long term fixation of new or existing crown, bridge and prosthesis.

P14 Angulated Abutment Adapter is to be used with implant diameter 4.2mm and higher.

11 Performance Standards or Special Controls

ISO 7405 Second edition 2008-12-15 Dentistry Evaluation of biocompatibility of . medical devices used in dentistry.
ISO 5832-3:1996 Implants for surgery -- Metallic materials -- Part 3: Wrought . titanium 6-aluminium 4-vanadium alloy.
ISO 14801 Second edition 2007-11-15 Dentistry-Implants-Dynamic fatigue test for . endosseous dental implants.
FDA quidance document: Class II Special Controls Guidance Document: Root-form . Endosseous Dental Implants and Endosseous Dental Abutments - Guidance for Industry and FDA Staff.

ס״ד

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12 Substantial Equivalence

	Candidate	Predicate Device	Predicate Device
	A.B. Dental Devices	Alpha Bio Tec K063364
Product Name	I2 - Conical Implant	DFI
Material	GR-5 Titanium Ti-6Al-4V ELI	GR-5 Titanium Ti-6Al-4V ELI
Implant Body Contour	Tapered	Tapered
Implant / Abutment connection	Internal Hex	Internal Hex
Surface	Calcium Fosfat-Hydroxyapatite	Sand Blast & Acid Etched
	A.B. Dental Devices	NobelBlocare K103089
Product Name	I5 - Conical Implant	Nobel Active
Material	GR-5 Titanium Ti-6Al-4V ELI	CP4 Titanium
Implant Body Contour	Tapered & Conical	Tapered & Conical
Implant / Abutment connection	Internal Hex	Internal Hex
Surface	Calcium Fosfat-Hydroxyapatite	TiUnite
	A.B. Dental Devices	Alpha Bio Tec K063364	Alpha Bio Tec K063364
Product Name	I6 - Narrow Integral Implant	ARS	ARRP
Material	GR-5 Titanium Ti-6Al-4V ELI	GR-5 Titanium Ti-6Al-4V ELI	GR-5 Titanium Ti-6Al-4V ELI
Implant Body Contour	Tapered & Conical	Tapered	Tapered
Implant / Abutment connection	Onepiece - Implant integratedwith abutment	Onepiece - Implant integratedwith abutment	Onepiece - Implant integratedwith abutment
Surface	Calcium Fosfat-Hydroxyapatite	Acid etched orSand Blast & Acid Etched	Sand Blast & Acid Etched
	A.B. Dental Devices	Alpha Bio Tec K063364	IMTEC CORP K031106
Product Name	I6b - Ball Attachment Implantt	ARB/ARSB	IMTEC MDI SENDAX
Material	GR-5 Titanium Ti-6Al-4V ELI	GR-5 Titanium Ti-6Al-4V ELI	GR-5 Titanium Ti-6Al-4V ELI
Implant Body Contour	Tapered & Conical	Straight or Tapered	Straight or Tapered
Implant / Abutment connection	Onepiece - Implant integratedwith ball abutment	Onepiece - Implant integratedwith ball abutment	Onepiece - Implant integratedwith ball abutment
Surface	Calcium Fosfat-Hydroxyapatite	Acid etched orSand Blast & Acid Etched	Enhanced surface treatment
	A.B. Dental Devices	Alpha Bio Tec K063364
Product Name	I6B - Narrow Implant	ARRC
Material	GR-5 Titanium Ti-6Al-4V ELI	GR-5 Titanium Ti-6Al-4V ELI
Implant Body Contour	Tapered & Conical	Tapered
Implant / Abutment connection	Implant integrated withabutment (+ internal hex)	Implant integrated withabutment (+ internal hex)
Surface	Calcium Fosfat-	Sand Blast & Acid Etched
	Hydroxyapatite
	A.B. Dental Devices	Nobel Biocare K102436	MIS K092555
Product Name	I6BI - Narrow Implant	NobelActive 3.0	UNO Narrow Implants
Material	GR-5 Titanium Ti-6Al-4V ELI	4 CP Titanium	GR-5 Titanium Ti-6Al-4V ELI
Implant BodyContour	Tapered & Conical	Tapered	Tapered
Implant / Abutmentconnection	Internal hex	Internal hex	Internal hex
Surface	Calcium Fosfat-Hydroxyapatite	TiUnite	Sand Blast & Acid Etched

・ : :

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Summary of Equivalence: .

A.B. DENTAL DEVICES® Dental Implants System shares similarity or very identical to its predicate devices in terms of intended use, indication for use, technological characteristics, performance and user interface.

As demonstrated by the substantial equivalent table, the differences raise no new issues of safety or effectiveness, since A.B. DENTAL DEVICES® Dental Abutments System shares similarity or very identical to its predicate devices.

Non Clinical Testing

Mechanical Testing - A.B. DENTAL DEVICES® has conducted Fatigue - Static & Cycling tests which comply with ISO 14801 Second edition 2007-11-15 Dentistry-Implants-Dynamic fatique test for endosseous dental implants; The test results have demonstrated the high resistance and high ability with the use of A.B. DENTAL DEVICES® Dental Implant System. Therefore, A.B. DENTAL DEVICES® Dental Implants System raises no new issues of safety or effectiveness than the predicate devices.

Safety & Effectiveness testing

Risk Assessment was conducted and has demonstrated no new safety and/or effectiveness issues than the predicate devices.

Conclusion:

As verified by bench testing, mechanical testing, risk assessment and substantial equivalence, A.B. DENTAL DEVICES® Dental Implant System shares similarity with its predicated devices by term of intended use, raw material and technical design. The fundamental scientific technology of the device is identical or very similar to the referenced predicate devices, thus A.B. DENTAL DEVICES® Dental Implant System is considered to

{5}------------------------------------------------

be substantially equivalent to its predicate devices and raises no new safety and/or effectiveness issues than the predicate devices.

. .

and the comments of the country of the country of

and the comments of the country

. . . . . . . . . . . . . . . . .

. . . . . . .

. . . . .

. . . . . .

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Image /page/6/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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure.

Public Health Service

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

January 21, 2014

A.B. Dental Devices, Limited c/o Ms. Daniela Levy Regulatory Consultant Sterling Medical Registration 22817 Ventura Blvd. #161 Woodland Hills, CA 91364

Re: K132125

Trade/Device Name: A.B. DENTAL DEVICES® Dental Implants System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental IMPLANT Regulatory Class: II Product Code: DZE, NHA Dated: December 11, 2013 Received: December 20, 2013

Dear Ms. Levy:

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

{7}------------------------------------------------

Page 2 - Ms. Levy

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 (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 yours.

Image /page/7/Picture/8 description: The image shows the name "Erin Dweith" in a bold, sans-serif font. The letters "FLDK" in the middle of the name have a unique, outlined design with multiple parallel lines. The rest of the letters are solid black.

Erin I. Keith, M.S. 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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Page 1 of

SECTION 4 - ------------------------------------------------------------------------------------------------------------------------------------------------------------------

510(k) Number (if known): K. 32125

Device Name:

A.B.DENTAL DEVICES® Dental Implants System

Indications for Use:

Two Stage Implants: 12, 15, 16BI.

One Stage: 16, 16b, 16B.

One stage & One-Piece 2.4 mm diameter implants for temporary use or long term use: 16, 16b, permit immediate splint stability and long term fixation of new or existing crown, bridge and prosthesis.

P14 Angulated Abutment Adapter is to be used with implant diameter 4.2mm and higher.

Over-The-Counter Use_ AND/OR Prescription Use _ V _ (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary S. Runner -S

Susan Runnn DDS, MA 2014.01.21

12:00:34-05'00'

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.