15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 1.5MM, 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 3MM, 15 ESTHETIC ABUTMENT NOBELACTIVE

K111581 · Nobel Biocare AB · NHA · Jun 23, 2011 · Dental

Device Facts

• Record ID: K111581
• Device Name: 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 1.5MM, 15 ESTHETIC ABUTMENT NOBELACTIVE 03.0 3MM, 15 ESTHETIC ABUTMENT NOBELACTIVE
• Applicant: Nobel Biocare AB
• Product Code: NHA · Dental
• Decision Date: Jun 23, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

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 Angled Abutment is a dental component used with the NobelActive 3.0 implant system. Made of titanium vanadium alloy; features 15-degree angulation and internal hex connection. Used by dentists in clinical settings to support prosthetic devices (artificial teeth) for partially edentulous patients. Device provides structural support for dental restorations; enables correction of implant angulation. Benefits patient by restoring chewing function. Performance validated via fatigue testing per FDA guidance.

Clinical Evidence

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

Technological Characteristics

Material: Titanium vanadium alloy. Connection: Internal hex. Angulation: 15 degrees. Energy source: None (mechanical). Sterilization: Not specified. Compliance: Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments.

Indications for Use

Indicated for partially edentulous patients with missing maxillary lateral incisors or mandibular central/lateral incisors to support prosthetic devices for chewing function restoration. Supports immediate function if stability requirements are met.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). 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.)

Predicate Devices

• NobelActive 3.0 (K102436)

Submission Summary (Full Text)

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K111581

JUN 2 3 9

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

| Submitted by: | Herbert Crane<br>Director, Global Regulatory Affairs |
|---------------------------------------------------------------------|----------------------------------------------------------------------------|
| Address: | Nobel Biocare USA LLC<br>22715 Savi Ranch Parkway<br>Yorba Linda, CA 92887 |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| Date of Submission: | June 6, 2011 |
| Classification Name: | Endosseous Dental Implant Abutment (21 CFR 872.3630) |
| Trade or Proprietary<br>or Model Name: | NobelActive 3.0 Angled Abutment |
| Legally Marketed Devices: Nobel Biocare - NobelActive 3.0 (K102436) | |

## Device Description:

The NobelActive 3.0 Angled Abutment is an angled abutment intended to be used with the Nobel Biocare NobelActive 3.0 implant system. The abutments are made of 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 substantial equivalence. Non-clinical testing consisted of performance of fatigue testing in accordance with the FDA guidance Class ال 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:

No clinical testing was performed. Non-clinical test data was used to support the decision of safety and effectiveness.

#### Conclusions:

The testing indicates that the abutments are substantially equivalent to the identified predicates.

Nobel Biocare Special 510(k) Notification NobelActive 3.0 Angled Abutments June 2011

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51υ(k) Summary of Safety and Effectivenes 1.4

Substantial Equivalence Comparison to Predicate Devices

| CHARACTERISTIC | PREDICATE | CANDIDATE |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | NobelActive 3.0<br>(K102436) | NobelActive 3.0 Angled Abutments |
| Trade Name | NobelActive | NobelActive |
| Anatomical Site | Oral Cavity | Oral Cavity |
| Abutment Material | Titanium Vanadium Alloy | Titanium Vanadium Alloy |
| Abutment angulation | 0 deg | 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. | 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 Special 510(k) Notification
NobelActive 3.0 Angled Abutments
June 2011

# 000019

F

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#### Performance Standards 1.5

·

The Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments; Guidance for Industry and FDA Staff (May 12, 2004) was identified as applicable to this submission.

.

Nobel Biocare Special 510(k) Notification NobelActive 3.0 Angled Abutments June 2011

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.

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

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

JUN 2 3 2011

Re: K111581

Trade/Device Name: NobelActive 3.0 Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Il Product Code: NHA Dated: June 6, 2011 Received: June 7, 2011

Dear Mr. Crane:

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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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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.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 vours

Susan Runne

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

Enclosure

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# Indications for Use

510(k) Number (if known): KINSB)

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 Runner

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

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