NOVA Dental Implants System

K150363 · Nova Implants , Ltd. · DZE · Jun 29, 2015 · Dental

Device Facts

• Record ID: K150363
• Device Name: NOVA Dental Implants System
• Applicant: Nova Implants , Ltd.
• Product Code: DZE · Dental
• Decision Date: Jun 29, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

NOVA® 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. NOVA® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Device Story

The NOVA® Dental Implants System consists of internal hex dental implants, cover screws, healing caps, abutments, and surgical instruments. The system is used by dental professionals in clinical settings for the surgical placement of implants into the jawbone to support prosthetic restorations. The implants are threaded, root-form devices made of Ti-6Al-4V ELI titanium alloy. The system includes various implant geometries (straight and tapered) and a range of abutment types (straight, angulated, anatomic, and ball attachments). The device is placed using conventional surgical drills. The output is a stable foundation for artificial teeth, which restores the patient's chewing function. The system supports immediate loading protocols when primary stability is sufficient. The device benefits patients by providing a functional and aesthetic replacement for missing teeth.

Clinical Evidence

No clinical data included. Evidence consists of bench testing, including mechanical fatigue testing (ISO 14801), biocompatibility testing (ISO 7405), sterilization validation (SAL 10^-6), and shelf-life testing.

Technological Characteristics

Root-form, threaded, internal hex dental implants and abutments. Material: Titanium alloy (Ti-6Al-4V ELI) per ASTM F136 and ISO 5832-3. Surface treatments: sand-blasted/acid-etched and anodized. Sterilization: Gamma radiation. Dimensions: Diameters 3.3–6.0 mm; lengths 8–16 mm.

Indications for Use

Indicated for surgical and restorative applications in the upper or lower jaw to support prosthetic devices (artificial teeth) to restore chewing function. Indicated for immediate loading when primary stability and appropriate occlusal loading are achieved.

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

• Alpha-Bio Tec (K063364)

Reference Devices

• SGS International (K133362)
• A.B.Dental Devices (K051719, K112440, K132125)
• Paltop (K112795)
• Nobel Biocare (K050705)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol featuring three human profiles facing to the right, with flowing lines connecting them.

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

June 29, 2015

NOVA® Implants Ltd. c/o Ms. Daniela Levy Sterling Medical Registration 22817 Ventura Blvd Woodland Hills, California 91364

Re: K150363

Trade/Device Name: NOVA® Dental Implants System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 13, 2015 Received: May 27, 2015

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.

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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 yours,

Tina
Kiang -S

for Erin I. Keith, M.S. 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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Image /page/2/Picture/0 description: The image shows the logo for Nova Implants. The word "NOVA" is in large, bold, black letters, with a red accent mark above the "V". Below "NOVA" is the word "IMPLANTS" in red, and below that is the phrase "MEDICAL DEVICES & DEVELOPMENT" in a smaller, thinner font, also in red.

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SECTION 4 - Indication for Use Statement

| 510(k) Number (if known): | K150363 |
|--------------------------------|-------------------------------------------------|
| Device Name: | NOVA ^® Dental Implants System |
| Indications for Use (Describe) | |
| Indications for Use: | |

NOVA® 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. NOVA® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|-------------------------------------------|
| <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use(21 CFR 801 Subpart |

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED

# FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/0 description: The image is a logo for Nova Implants Medical Devices & Development. The word "NOVA" is in large, bold, black letters, with a red accent mark above the "V". Below "NOVA" is the word "IMPLANTS" in red, followed by the words "MEDICAL DEVICES & DEVELOPMENT" in a smaller font size and gray color.

#### 510(k) Summary (21 CFR 807.92) SECTION 5

# 510(k) Number K____________

| 1 | Submission Owner | NOVA® Implants Ltd.<br>Dan Grimberg – CEO<br>5 Yoni Nethanyhu st.,<br>Or Yehuda ZIP 6037603<br>ISRAEL<br>Phone : [phone]<br>Fax : [phone] |
|---|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2 | Official Correspondent<br>Contact Person | Sterling Medical Registration<br>Daniela Levy - Regulatory Consultant<br>22817 Ventura blvd.<br>Woodland Hills, CA 91364<br>Phone: [phone]<br>Email: [e-mail] |
| 3 | Submission Date | June 21, 2015 |
| 4 | Device Trade Name | NOVA® Dental Implants System |
| 5 | Regulation Description | Root-form Endosseous Dental Implants and Abutments |
| 6 | Classification | Device Name : Endosseous dental implant<br>Product Code : DZE, NHA<br>Regulation No : 872.3640<br>Class : II<br>Panel : Dental |
| 7 | Reason for the Premarket Notification Submission | : New Device |

- 8 Identification of Legally Marketed Predicate Devices :
- NOVA® Dental Implants System is substantially equivalent to Alpha-Bio Tec K063364 (primary predicate); And referenced predicate devices: SGS International K133362; A.B.Dental Devices K051719, K112440, K132125; Paltop K112795; Nobel Biocare

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Image /page/4/Picture/0 description: The image shows the logo for Nova Implants Medical Devices & Development. The word "NOVA" is in large, bold, black letters. Above the "V" is a small red shape that resembles a flame or a stylized checkmark. Below "NOVA" is the word "IMPLANTS" in red, followed by "MEDICAL DEVICES & DEVELOPMENT" in a smaller, black font.

K050705;

in terms of intended use, indication for use, technological characteristics, performance and user interface.

The predicate devices are a Class II medical device.

- ഗ Device Description:
NOVA® Dental Implants System consists of internal hex dental implants. cover screws and healing caps; abutments system and superstructures; impression copy system & surgical instruments.

Internal hex implants:-

PSI implants are provided in diameters: 3.3, 3.75, 4.2, 5 & 6 with lengths 8, 10, 11.5, 13, & 16 mm. (16 mm is not provided for 6 mm diameter).

PCI implants are provided in diameters: 3.3, 3.75, 4.2, 5 & 6 with lengths 8, 10, 11.5,

13, & 16 mm. (16 mm is not provided for 6 mm diameter).

NOVA Dental Abutments internal hex system provides:

Healing Caps:

HC Series - Narrow (3.75 mm) - Platform height 2,3,4,5,6,7

HC Series - Standard (4.7 mm) - Platform height 2.3.4.5.6.7

HCW Series - Wide (6.00 mm) - Platform height 3,4,5,6

PMI Series - Premium (3.75, 4.7, 6.0 mm) - Platform height 2,3,4,5,6,7

Straight Abutments (Long, straight, narrow, anatomic, curve):

ST Series: Length 8.5, 9.5, 11.5, 12.5 mm.

STA Series: With Shoulder profile height 1, Length 9 mm; profile height 2, Length 10; profile height 3, Length 11; profile height 4 Length 12.

STN: Narrow length 11 mm.

SLM Series: Anatomic Straight Abutment: profile height 1,2,3 length 9,10,11 mm.

SCM Series: Anatomic Straight Abutment: profile height 1.2.3 length 9.10.11 mm.

Angulated Abutments (standard, anatomic, curve):

Standard Angulated Abutment Length 7,9,11 Angulations 15°, 25°.

Anatomic Angulated Abutments Platform height 1,2,3,4 Angulations 15°, 25°.

Anatomic Angulated Curve Platform height 1,2,3, Angulations 15°, 25° .

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Image /page/5/Picture/0 description: The image shows the logo for Nova Implants. The word "NOVA" is in large, bold, black letters, with a red check mark above the "V". Below "NOVA" is the word "IMPLANTS" in red letters. Underneath "IMPLANTS" is the phrase "MEDICAL DEVICES & DEVELOPMENT" in smaller, gray letters.

Ball Attachments Platform height 1.2.3.4.5.6 and related components covers and caps. Material:

NOVA® Dental Implants System and Dental Abutments System is made of Titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136.

- 10 Intended use / Indication for Use:
NOVA ® 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. NOVA ® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

- 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 fatique test for . endosseous dental implants.
- FDA guidance document: Class II Special Controls Guidance Document: Root-form . Endosseous Dental Implants and Endosseous Dental Abutments - Guidance for Industry and FDA Staff.

| Substantial Equivalent<br>Table | Candidate No.1 | PREDICATE DEVICE |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CHARACTERISTIC | PCI Dental Implant | ATID Internal Hex Implants |
| 510k | | K063364 (primary predicate) |
| Company Name | NOVA Implants Ltd. | Alpha-Bio Tec Ltd. |
| Indication for Use | NOVA® Dental Implants System is<br>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. NOVA®<br>Dental Implants System is indicated also<br>for immediate loading when good<br>primary stability is achieved and with | The Alpha-Bio Dental Implant<br>System® is indicated for use in<br>surgical and restorative applications<br>for placement in the bone of the upper<br>or lower jaw to provide support for<br>prosthetic devices, such as artificial<br>teeth, in order to restore the patient's<br>chewing function.<br>Two stage: ATID,<br>DFI,SPI,SFB,ATIE OF, ITO, SPR<br>One stage: ITO, SPR<br>One stage and One Piece: ARRP, |
| | appropriate occlusal loading. | ARPB, ARRC 3mmd diameter are<br>intended only for placement at the<br>mandibular central and lateral incisors<br>and maxillary and lateral incisors.<br>Indicated also for denture stabilization<br>using multiple implants<br>One stage and One Piece for<br>temporary use: ARR, ARB, ARS,<br>ARSB permit immediate splint stability<br>for crown, bridge and prosthesis,<br>protect graft sites.<br>The Alpha-Bio Dental Implant<br>System® is indicated also for<br>immediate loading when good primary<br>stability is achieved and with<br>appropriate occlusal loading. DFI, SPI,<br>ARRP, ARPB.<br>The Alpha-Bio Dental Implant<br>System® is indicated also for<br>immediate loading on single tooth<br>when good primary stability is<br>achieved and with appropriate occlusal<br>loading. SPI, SFB.<br>All implants with diameter 3.3mmd<br>should not use angled abutment. |
| Device Design | Threaded, root form endosseous implants | Threaded, root form endosseous implants |
| Classification | Class 2 872.3640 P.Code DZE | Class 2 872.3640 P.Code DZE |
| Material | GR-5 Titanium Ti-6Al-4V ELI | GR-5 Titanium Ti-6Al-4V ELI |
| Diameters mm | 3.3, 3.75, 4.2, 5, 6 | 3.3, 3.75, 4.2, 5, 6 |
| Lengths mm | 8, 10, 11.5, 13, 16 [16 not for 6 mm] | 8, 10, 11.5, 13, 16 |
| Implant Body Contour | Straight | Straight |
| Anatomical Site | Oral Cavity | Oral Cavity |
| Principle of operation | Conventional procedure | Conventional procedure |
| Self tapping | ✓ | ✓ |
| Sterilization | Gamma Ray | Gamma Ray |
| Packaging | Double packaging | Double packaging |
| Bone preparation Procedure | Conventional drills | Conventional drills |
| Substantial Equivalent<br>Table | Candidate No.2 | PREDICATE DEVICE |
| CHARACTERISTIC | PSI Dental Implant | SPI Internal Hex Implants |
| 510k | | K063364<br>(primary predicate) |
| Company Name | NOVA Implants Ltd. | Alpha-Bio Tec Ltd. |
| Indication for Use | NOVA® Dental Implants System is<br>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. NOVA® | The Alpha-Bio Dental Implant<br>System® is indicated for use in<br>surgical and restorative applications<br>for placement in the bone of the upper<br>or lower jaw to provide support for<br>prosthetic devices, such as artificial<br>teeth, in order to restore the patient's<br>chewing function. |
| | Dental Implants System is indicated also<br>loading when<br>immediate<br>for<br>good<br>primary stability is achieved and with<br>appropriate occlusal loading. | ATID.<br>Two<br>stage:<br>DFI,SPI,SFB,ATIE OF, ITO, SPR<br>ITO, SPR<br>One stage:<br>One stage and One Piece: ARRP,<br>ARPB, ARRC 3mmd diameter are<br>intended only for placement at the<br>mandibular central and lateral incisors<br>and maxillary and lateral incisors.<br>Indicated also for denture stabilization<br>using multiple implants<br>One stage and One<br>Piece for<br>temporary use: ARR, ARB, ARS,<br>ARSB permit immediate splint stability<br>for crown, bridge and prosthesis,<br>protect graft sites.<br>Alpha-Bio<br>Dental<br>The<br>Implant<br>is indicated also for<br>System®<br>immediate loading when good primary<br>is achieved<br>stability<br>and<br>with<br>appropriate occlusal loading. DFI, SPI,<br>ARRP, ARPB.<br>Alpha-Bio<br>The<br>Implant<br>Dental<br>indicated<br>also<br>System®<br>is<br>for<br>immediate loading on single tooth<br>good primary stability<br>when<br>ાડ<br>achieved and with appropriate occlusal<br>loading. SPI, SFB.<br>All implants with diameter 3.3mmd<br>should not use angled abutment. |
| Device Design | Threaded, root form endosseous<br>implants | Threaded, root form endosseous<br>implants |
| Classification | Class 2 872.3640<br>P.Code DZE | Class 2 872.3640<br>P.Code DZE |
| Material | GR-5 Titanium Ti-6AI-4V ELI | GR-5 Titanium Ti-6Al-4V ELI |
| Diameters mm | 3.3, 3.75, 4.2, 5, 6 | 3.3, 3.75, 4.2, 5, 6 |
| Lengths<br>mm | 8, 10, 11.5, 13, 16 [16 not for 6 mm] | 8, 10, 11.5, 13, 16 |
| Implant Body Contour | Tapered | Tapered |
| Anatomical Site | Oral Cavity | Oral Cavity |
| Principle of operation | Conventional procedure | Conventional procedure |
| Self tapping | V | V |
| Sterilization | Gamma Ray | Gamma Ray |
| Packaging | Double packaging | Double packaging |
| Bone preparation Procedure | Conventional drills | Conventional drills |

#### 12 Substantial Equivalence

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Image /page/6/Picture/0 description: The image shows the logo for Nova Implants Medical Devices & Development. The word "Nova" is in large, bold, black letters. Above the "v" is a small red diamond shape. Below "Nova" is the word "Implants" in red, and below that is the phrase "Medical Devices & Development" in smaller red letters.

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Image /page/7/Picture/0 description: The image is a logo for Nova Implants Medical Devices & Development. The word "NOVA" is in large, bold, black letters, with a red accent mark above the "V". Below "NOVA" is the word "IMPLANTS" in red, followed by the words "MEDICAL DEVICES & DEVELOPMENT" in a smaller font, also in red. The logo is clean and modern, with a focus on the company name and its area of expertise.

| | Product Code: NHA Regulation No. 872.3630 | | |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | |
| | Candidate | Reference Predicate Device | Reference Predicate Device |
| | NOVA Implants Itd | SGS International Itd | A.B.DENTAL DEVICES |
| Product Name | Healing Abutments (PMI) | Healing Abutments<br>(HN,HNN,HWN) | PON |
| K Number |…