A.B. DENTAL DEVICES Dental Implants System

K162482 · A.B. Dental Device , Ltd. · DZE · Sep 15, 2017 · Dental

Device Facts

• Record ID: K162482
• Device Name: A.B. DENTAL DEVICES Dental Implants System
• Applicant: A.B. Dental Device , Ltd.
• Product Code: DZE · Dental
• Decision Date: Sep 15, 2017
• 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: 122, 15, 155, 110. P4 and P14 angled abutments are to be used only with standard platform implants 3.5 mm in diameter or larger.

Device Story

Endosseous dental implant system; includes one and two-stage implants, abutments, and healing caps. Implants placed surgically into upper or lower jaw bone by dental professionals; provide support for prosthetic devices (artificial teeth). System restores patient chewing function. Supports immediate loading protocols when primary stability is achieved. Components include various diameters and lengths; tapered profiles; sand-blasted CaP surface treatment. Device output is the physical support structure for dental prosthetics. Clinical benefit is restoration of masticatory function.

Clinical Evidence

Bench testing only. Includes fatigue testing per ISO 14801:2007 on worst-case implant/abutment combinations, cytotoxicity testing per ISO 10993-5, biological risk assessment, sterilization validation (gamma per ISO 11137, steam per ANSI/AAMI/ISO 17665-1:2006), packaging validation, accelerated shelf-life testing, and LAL testing for sterility.

Technological Characteristics

Materials: Ti-6Al-4V. Design: Tapered endosseous implants, internal hexagonal and one-piece systems. Surface: Sand-blasted with CaP. Sterilization: Gamma (sterile components) and steam (non-sterile components). Standards: ISO 14801 (fatigue), ISO 10993-5 (cytotoxicity), ISO 11137 (gamma), ANSI/AAMI/ISO 17665-1:2006 (steam).

Indications for Use

Indicated for patients requiring dental implants in the upper or lower jaw to support prosthetic devices (artificial teeth) and restore chewing function. Includes immediate loading when primary stability and occlusal loading conditions are met. P4 and P14 angled abutments restricted to standard platform implants ≥3.5 mm diameter.

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

• A.B. DENTAL DEVICES® Dental Implants System (K132125)
• A.B. DENTAL DEVICES® Dental Implants System (K051719)
• A.B. DENTAL DEVICES® Dental Implants System (K112440)
• Nobel Biocare AB NobelActive (K071370)

Submission Summary (Full Text)

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

September 15, 2017

A. B. Dental Device Ltd. % John Smith, M.D., J.D. Partner Hogan Lovells US LLP 555 13th St. NW Washington, District of Columbia 20004

Re: K162482

Trade/Device Name: A.B. DENTAL DEVICES® Dental Implants System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: August 15, 2017 Received: August 15, 2017

Dear Dr. John Smith:

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.

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Andrew I. Steen -S

for 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

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page

510(k) Number (if known)

K162482

Device Name

#### A.B. DENTAL DEVICES® Dental Implants System

Indications for Use (Describe)

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 lmplants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Two Stage Implants: 122, 15, 155, 110.

P4 and P14 angled abutments are to be used only with standard platform implants 3.5 mm in diameter or larger.

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)

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

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (8/14)

Page 1 of 1 FDA

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#### K162482 510(k) SUMMARY A.B. Dental Devices Dental Implant System

#### Submitter:

A.B. Dental Devices Ltd. 19 Havalomim St., Ashdod 7761117 lsrael

Phone: [phone] Facsimile: 972-8-8522562 Contact Person: Gabi Krauss, RA Manager

Date Prepared: September 15, 2017

Name of Device: A.B. DENTAL DEVICES® Dental Implants System Common or Usual Name: Root-form Endosseous Dental Implants & Abutments Classification Name: Endosseous dental implant; 21 CFR §872.3640 Product Code: DZE, Additional Product Code NHA

### Predicate Device

K132125 A.B. DENTAL DEVICES® Dental Implants System (primary) K051719 A.B. DENTAL DEVICES® Dental Implants System (reference) K112440 A.B. DENTAL DEVICES® Dental Implants System (reference) K071370 Nobel Biocare AB NobelActive (reference)

### 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: 122, 15, 155, 110.

P4 and P14 angled abutments are to be used only with standard platform implants 3.5 mm in diameter or larger.

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# Device Description and Technological Characteristics

A.B. DENTAL DEVICES® Dental Implants System consists of one and two stage endosseous form dental implants, internal hexagonal and one piece implants systems. Narrow platform implants are to be used with straight abutments only. The following components are being added:

| Implant | Platform | Diameter, mm | Length, mm |
|---------|----------|--------------|---------------------|
| I22 | Standard | 3.75 | 8, 10, 11.5, 13, 16 |
| | | 4.2 | 8, 10, 11.5, 13, 16 |
| | | 4.5 | 8, 10, 11.5, 13, 16 |
| | | 5 | 8, 10, 11.5, 13, 16 |
| I5 | Narrow | 3.3 | 10, 11.5, 13, 16 |
| I55 | Narrow | 3.3 | 10, 11.5, 13, 16 |
| | | 3.5 | 8, 10, 11.5, 13, 16 |
| | Standard | 3.75 | 8, 10, 11.5, 13, 16 |
| | | 4.2 | 8, 10, 11.5, 13, 16 |
| | | 4.5 | 8, 10, 11.5, 13, 16 |
| | | 5 | 8, 10, 11.5, 13, 16 |
| | | 6 | 8, 10, 11.5, 13, 16 |
| I10 | Standard | 4.5 | 10, 11.5, 13, 16 |

Abutments:

- P0-14 Healing caps, 2.5 7 mm heights .
- P3-5 straight abutments, 5 mm diameter, 7 9 mm length ●
- P4 angled abutments, 15 - 25 degree angulation, standard platform, standard and long lengths

## Technological Characteristics Comparison

The purpose of this 510(k) is to expand the current product line to include two new endosseous implant product lines (122 and 155). Minor additions to existing implant lines have also been added. Comparison tables for each modification are provided below.

| | Subject I5 | Predicate I5 | Predicate I6bi |
|-------------------|-----------------------|---------------------------|-----------------------|
| K-number | K162482 | K132125, K112440 | K132125 |
| Material | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-4V |
| Diameter, mm | 3.3 | 3.5, 3.75, 4.2, 4.5, 5, 6 | 3 |
| Platform | Narrow | Standard | Narrow |
| Length, mm | 10, 11.5, 13, 16 | 8, 10, 11.5, 13, 16 | 10, 11.5, 13, 16 |
| Profile | Tapered | Tapered | Tapered |
| Surface Treatment | Sand blasted with CaP | Sand blasted with CaP | Sand blasted with CaP |
| Sterility | Sterile | Sterile | Sterile |

| | Subject I10 | Predicate I10 |
|--------------|------------------|------------------|
| K-number | K162482 | K112440 |
| Material | Ti-6Al-4V | Ti-6Al-4V |
| Diameter, mm | 4.5 | 3.75, 4.2, 5 |
| Platform | Standard | Standard |
| Length, mm | 10, 11.5, 13, 16 | 10, 11.5, 13, 16 |
| Profile | Tapered | Tapered |

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| Surface Treatment | Sand blasted with CaP | Sand blasted with CaP |
|-------------------|-----------------------|-----------------------|
| Sterility | Sterile | Sterile |

| | Subject 122 | Predicate 12 |
|-------------------|-----------------------|-----------------------------|
| K-number | K162482 | K132125, K112440 |
| Material | Ti-6Al-4V | Ti-6Al-4V |
| Diameter, mm | 3.75, 4.2, 4.5, 5 | 3.5, 3.75, 4.2, 4.5, 5, 6 |
| Platform | Standard | Standard |
| Length, mm | 8, 10, 11.5, 13, 16 | 8, 10, 11.5, 13, 16, 18, 20 |
| Profile | Tapered | Tapered |
| Surface Treatment | Sand blasted with CaP | Sand blasted with CaP |
| Sterility | Sterile | Sterile |

| | Subject I55 | Predicate I5 | Predicate I6bi |
|-------------------|------------------------------------|---------------------------|-----------------------|
| K-number | K162482 | K132125, K112440 | K132125 |
| Material | Ti-6Al-4V | Ti-6Al-4V | Ti-6Al-4V |
| Diameter, mm | 3.3,3.5, 3.75, 4.2, 4.5, 5, 6 | 3.5, 3.75, 4.2, 4.5, 5, 6 | 3 |
| Platform | Narrow (≤3.5) and Standard (≥3.75) | Standard | Narrow |
| Length, mm | 8, 10, 11.5, 13, 16 | 8, 10, 11.5, 13, 16 | 10, 11.5, 13, 16 |
| Profile | Tapered | Tapered | Tapered |
| Surface Treatment | Sand blasted with CaP | Sand blasted with CaP | Sand blasted with CaP |
| Sterility | Sterile | Sterile | Sterile |

| | Subject P0 Healing Caps | Predicate P0 Caps |
|-------------------|-------------------------|-----------------------|
| K-number | K162482 | K132125 |
| Material | Ti-6Al-4V | Ti-6Al-4V |
| Connection Method | Taper fit | Screw |
| Platform | P14 angled abutments | Narrow, Standard |
| Length, mm | 2.5, 4, 5, 7 | 0.5, 2, 3, 4, 5, 6, 7 |
| Sterility | Non-Sterile | Non-Sterile |

| | Subject P3-5 | Predicate P3 |
|--------------|---------------|--------------------|
| K-number | K162482 | K132125, K112440 |
| Material | Ti-6Al-4V | Ti-6Al-4V |
| Diameter, mm | 5 | 3.75, 4.5, 5.5 |
| Platform | Standard | Narrow, Standard |
| Length, mm | 7,9 | 5, 7, 9, 11,12, 15 |
| Design | Anti-rotation | Anti-rotation |
| Sterility | Non-Sterile | Non-Sterile |

| | Subject P4 | Predicate P4 |
|--------------|------------|--------------|
| K-number | K162482 | K132125 |
| Material | Ti-6Al-4V | Ti-6Al-4V |
| Diameter, mm | 3.75, 5 | 3.75 |
| Angle, ° | 15, 25 | 15 |
| Platform | Standard | Standard |

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| Length, mm | 8, 9, 15.5 | 15.7 |
|------------|----------------------------------|---------------------------------------|
| Design | Straight, Standard, Narrow, Long | Long, Anatomic (shoulder heights 1,3) |
| Sterility | Non-Sterile | Non-Sterile |

In addition, a comparison of the indications for use of the subject and primary predicate follows:

| | Subject A.B. DENTAL DEVICES®<br>Dental Implants System | Primary Predicate A.B. DENTAL DEVICES®<br>Dental Implants System |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K-number | K162482 | K132125 |
| Indications for Use | A.B. DENTAL DEVICES® Dental<br>Implants System is indicated for<br>use in surgical and restorative<br>applications for placement in the<br>bone of the upper or lower jaw to<br>provide support for prosthetic<br>devices, such as artificial teeth, in<br>order to restore the patient's<br>chewing function. A.B. DENTAL<br>DEVICES® Dental Implants System<br>is indicated also for immediate<br>loading when good primary<br>stability is achieved and with<br>appropriate occlusal loading.<br><br>Two Stage Implants: I22, I5, I55,<br>I10.<br><br>P4 and P14 angled abutments are to<br>be used only with standard platform<br>implants 3.5 mm in diameter or<br>larger. | A.B.DENTAL DEVICES® Dental Implants<br>System is indicated for use in surgical and<br>restorative applications for placement in<br>the bone of the upper or lower jaw to<br>provide support for prosthetic devices,<br>such as artificial teeth, in order to restore<br>the patient's chewing function. A.B.<br>DENTAL DEVICES® Dental Implants<br>System is indicated also for immediate<br>loading when good primary stability is<br>achieved and with appropriate occlusal<br>loading.<br>Two Stage Implants: I2, I5, I6BI.<br>One Stage: I6, I6b, I6B.<br>One Stage & One-Piece 3.0 mm diameter<br>implants: I6, I6B, I6BI, are intended for<br>placement at the mandibular central and<br>lateral incisors and maxillary and lateral<br>incisors. Indicated also for denture<br>stabilization using multiple implants.<br>One stage & One-Piece 2.4 mm diameter<br>implants for temporary use or long term<br>use: I6, I6b, permit immediate splint<br>stability and long term fixation of new or<br>existing crown, bridge and prosthesis.<br>P14 Angulated Abutment Adapter is to be<br>used with implant diameter 4.2mm and<br>higher. |

With regard to differences in the indications for use between the subject and primary predicate:

- . The list of two stage implants was updated to include the new endosseous implant product lines.
- Limitations for the 2.4 mm and 3.0 diameter implant bodies are not included because the subject ● devices do not contain any of that size.
- One stage indications were removed because the subject devices are only indicated for two stage. ●
- The indication for the P14 abutment was reduced to the standard platform implant diameter of 3.5 mm . or larger based on the fatigue testing provided.

## Performance Data

Fatigue testing per ISO 14801:2007 of the worst-case implant and abutment combination for the standard platform implants and abutments Engineering analysis to determine if additional components constitute a new worst-case.

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Cytotoxicity testing per ISO 10993-5 and biological risk assessment Gamma sterilization validation per ISO 11137 Steam sterilization validation per ANSI/AAMI/ISO 17665-1:2006 Packaging validation and accelerated shelf-life testing LAL testing in accordance with the FDA Guidance on Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile

## Substantial Equivalence

The AB Dental Implant System has the same indications and similar technological characteristics and principles of operation as its predicate device. The minor technological differences between the AB Dental Implant Systems do not raise different issues. Performance data demonstrate that the AB Dental Implant System is substantially equivalent.

### Conclusions

The AB Dental Implant System is substantially equivalent to the predicate device.