A.B. DENTAL DEVICES DENTAL IMPLANTS SYSTEM

K132125 · A.B. Dental Devices , Ltd. · DZE · Jan 21, 2014 · Dental

Device Facts

• Record ID: K132125
• Device Name: A.B. DENTAL DEVICES DENTAL IMPLANTS SYSTEM
• Applicant: A.B. Dental Devices , Ltd.
• Product Code: DZE · Dental
• Decision Date: Jan 21, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

A.B. DENTAL DEVICES® Dental Implants System comprises endosseous root-form dental implants and associated abutments; used in dental clinics by trained professionals. Implants are placed surgically into the jawbone to provide support for prosthetic devices like artificial teeth. System includes various configurations: two-stage, one-stage, and one-piece implants; diameters range from 2.4mm to 4.2mm+. Components include healing caps, screws, anti-rotation/anatomic/angular abutments, titanium sleeves, and impression systems. Device restores patient chewing function; supports denture stabilization; enables immediate loading when primary stability is achieved. Clinical benefit derived from mechanical support of prosthetic restorations. Bench testing, including fatigue and static/cycling tests per ISO 14801, validates structural integrity.

Clinical Evidence

No clinical data provided. Evidence is based on bench testing, including static and dynamic fatigue testing per ISO 14801, and biocompatibility evaluation per ISO 7405. Risk assessment confirms safety and effectiveness profile is equivalent to predicate devices.

Technological Characteristics

Materials: GR-5 Titanium (Ti-6Al-4V ELI) per ISO 5832-3. Design: Root-form endosseous implants with tapered/conical contours and internal hex or integrated abutment connections. Surface: Calcium Phosphate-Hydroxyapatite coating. Standards: ISO 7405 (biocompatibility), ISO 14801 (dynamic fatigue). Form factor: Various diameters (2.4mm-4.2mm+) and lengths (8mm-16mm).

Indications for Use

Indicated for patients requiring surgical and restorative dental implants in the upper or lower jaw to support prosthetic devices (artificial teeth) and restore chewing function. Includes immediate loading applications. Specific implants indicated for mandibular/maxillary central and lateral incisors, denture stabilization, and temporary or long-term fixation of crowns, bridges, and prostheses.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• M.I.S (K092555)
• Alpha Bio Tec (K063364)
• IMTEC (K031106)
• Nobel Biocare (K071370)
• Nobel Biocare (K102436)
• Nobel Biocare (K041876)
• M.I.S. (K040807)
• Biohorizon (K103691)
• Zimmer (K052600)
• Zimmer (K061847)
• A.B.Dental Devices (K051719)
• A.B.Dental Devices (K112440)
• Nobel Biocare (K072570)
• Nobel Biocare (K093643)
• Nobel Biocare (K031719)
• Nobel Biocare (K061529)
• Nobel Biocare (K091904)
• Nobel Biocare (K061477)
• Inclusive dental solutions (K083480)
• Zest Anchors (K083324)

Reference Devices

• NobelBlocare (K103089)
• MIS (K092555)

Submission Summary (Full Text)

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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 : [phone] | |
| Fax : [phone] | |
| Sterling Medical Registration | |
| Daniela Levy - Regulatory Consultant | |
| 22817 Ventura blvd. #161 | |
| Woodland Hills, CA 91364 | |
| Phone: [phone] | |
| Fax: [phone] | |
| Email [e-mail] | |
| 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

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.

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10 Intended use / Indication for Use:

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, 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-<br>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-<br>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 integrated<br>with abutment | Onepiece - Implant integrated<br>with abutment | Onepiece - Implant integrated<br>with abutment |
| Surface | Calcium Fosfat-<br>Hydroxyapatite | Acid etched or<br>Sand 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 integrated<br>with ball abutment | Onepiece - Implant integrated<br>with ball abutment | Onepiece - Implant integrated<br>with ball abutment |
| Surface | Calcium Fosfat-<br>Hydroxyapatite | Acid etched or<br>Sand 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 with<br>abutment (+ internal hex) | Implant integrated with<br>abutment (+ internal hex) | |
| Surface | Calcium Fosfat- | Sand Blast & Acid Etched | |
| | Hydroxyapatite | | |
| | <i>A.B. Dental Devices</i> | <i>Nobel Biocare K102436</i> | <i>MIS K092555</i> |
| 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 Body<br>Contour | Tapered & Conical | Tapered | Tapered |
| Implant / Abutment<br>connection | Internal hex | Internal hex | Internal hex |
| Surface | Calcium Fosfat-<br>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

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

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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:

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.

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'