NOBEL ACTIVE 3.0

K102436 · Nobel Biocare AB · DZE · Dec 9, 2010 · Dental

Device Facts

• Record ID: K102436
• Device Name: NOBEL ACTIVE 3.0
• Applicant: Nobel Biocare AB
• Product Code: DZE · Dental
• Decision Date: Dec 9, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NobelActive 3.0mm Implant is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. The NobelActive 3.0 implants may be put into immediate function provided that stability requirements detailed in the manual are satisfied.

Device Story

NobelActive 3.0 is an endosseous dental implant and abutment system designed for surgical placement in the jaw to support prosthetic teeth. The system consists of a 3.0 mm diameter CP titanium implant and titanium vanadium alloy healing, temporary, and final abutments. Used by dental clinicians in a clinical setting, the device is surgically implanted to restore chewing function in partially edentulous patients. The implant features an internal hex connection. Clinical benefit is derived from the restoration of dental function and esthetics. The device is evaluated for safety and effectiveness through fatigue testing to ensure it withstands anticipated masticatory forces.

Clinical Evidence

No clinical data. Safety and effectiveness were supported by non-clinical bench testing, specifically fatigue testing performed in accordance with the FDA guidance 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments'.

Technological Characteristics

Endosseous dental implant system. Implant material: CP titanium. Abutment material: Titanium vanadium alloy. Connection: Internal hex. Implant diameter: 3.0 mm. Implant lengths: 10.0 mm to 15.0 mm. Abutment angulation: 0 and 15 degrees. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for partially edentulous patients requiring treatment for missing maxillary lateral incisors or mandibular central and lateral incisors to support prosthetic devices (artificial teeth) and restore chewing function. May be used for immediate function if stability requirements are met.

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

• NobelActive Internal Connection Implant (K071370)

Submission Summary (Full Text)

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#### 510(k) Summary of Safety and Effectiveness 1.4

| Submitted by: | Herbert Crane<br>Director, Global Regulatory Affairs | DEC - 9 2010 |
|----------------------------------------|-----------------------------------------------------------------------------------------------------|--------------|
| Address: | Nobel Biocare USA LLC<br>22715 Savi Ranch Parkway<br>Yorba Linda, CA 92887 | |
| Telephone: | [phone] | |
| Facsimile: | [phone] | |
| Date of Submission: | August 25, 2010 | |
| Classification Name: | Endosseous Dental Implant (21 CFR 872.3640)<br>Endosseous Dental Implant Abutment (21 CFR 872.3630) | |
| Trade or Proprietary<br>or Model Name: | NobelActive 3.0 | |
| Legally Marketed Device(s): | NobelActive Internal Connection Implant (K071370) | |

# Device Description:

Nobel Biocare's NobelActive 3.0 is an endosseous dental implant and abutment system. The implant is 3.0 mm diameter and available in lengths from 10.0 mm to 15 mm. Implants are made from CP titanium. Healing, temporary, and final abultnents are included in the system. Abutments are made from titanium vanadium alloy.

# Indications for Use:

The NobelActive 3.0mm implant is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. The NobelActive 3.0 implants may be put into immediate function provided that stability requirements detailed in the manual are satisfied.

# Non-Clinical Testing:

Non-clinical test data was used to support the decision of safety and effectiveness. Non-clinical testing consisted of performance of fatigue testing in accordance with the FDA guidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. The testing indicates that the device is strong enough to withstand the anticipated forces.

# Clinical Testing:

Non-clinical test data was used to support the decision of safety and effectiveness.

# Conclusions:

The testing indicates that the device is safe and effective for its intended use and performs as well or better than the predicate devices.

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#### 510(k) Summary of Safety and Effectiveness 1.4

Substantial Equivalence Comparison to Predicate Devices

| CHARACTERISTIC | CANDIDATE | PREDICATE |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | NobelActive 3.0 | NobelActive Internal Connection Implant<br>(K071370) |
| Trade Name | NobelActive | NobelActive |
| Anatomical Site | Oral Cavity | Oral Cavity |
| Implant Material | Titanium | Titanium |
| Implant Diameters | 3.0 mm | 3.5, 4.3, 5.0 mm |
| Implant Lengths | 10.0, 11.5, 13.0, 15.0 mm | 10.0, 11.5, 13.0, 15.0 mm |
| Abutment Material | Titanium Vanadium Alloy | Titanium Vanadium Alloy |
| Abutment angulation | 0, 15 deg | 0, 15 deg |
| Implant/Abutment Connection | Internal Hex | Internal Hex |
| Indications for Use | The NobelActive 3.0mm implant is indicated for use in the<br>treatment of missing maxillary lateral incisors or the<br>mandibular central and lateral incisors to support prosthetic<br>devices, such as artificial teeth, in order to restore chewing<br>function in partially edentulous patients. The NobelActive<br>3.0 implants may be put into immediate function provided<br>that stability requirements detailed in the manual are<br>satisfied. | Nobel Biocare's NobelActive implants are endosseous<br>implant intended to be surgically placed in the bone of the<br>upper or lower jaw arches to provide support for prosthetic<br>devices, such as an artificial tooth, in order to restore<br>patient esthetics and chewing function. Nobel Biocare's<br>NobelActive implants are indicated for single or multiple<br>unit restorations in splinted or non-splinted applications.<br>Nobel Biocare's NobelActive implants may be placed<br>immediately and put into immediate function provided that<br>initial stability requirements detailed in the manual are<br>satisfied. |

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes forming its wings and body. The eagle is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference of the circle.

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

Mr. Herbert Crane Director, Global Regulatory Affairs Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887

FEB - 7 2011

Re: K102436

Trade/Device Name: NobelActive 3.0 Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: DZE, NHA Dated: November 16, 2010 Received: November 17, 2010

Dear Mr. Crane:

This letter corrects our substantially equivalent letter of December 9, 2010.

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 (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.

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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Page 2- Mr. Crane

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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DEC - 9 2010

Klo2436 510(k) Number (if known):

Device Name: NobelActive 3.0

Indications For Use:

The NobelActive 3.0mm Implant is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. The NobelActive 3.0 implants may be put into immediate function provided that stability requirements detailed in the manual are satisfied.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

、・・・

Susan Rispa

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices Page 1 of 1

510(k) Number: K100436