INCLUSIVE TITANIUM ABUTMENT BLANKS

K083192 · Inclusive Dental Solutions · NHA · Mar 4, 2009 · Dental

Device Facts

• Record ID: K083192
• Device Name: INCLUSIVE TITANIUM ABUTMENT BLANKS
• Applicant: Inclusive Dental Solutions
• Product Code: NHA · Dental
• Decision Date: Mar 4, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Inclusive Titanium Abutment Blank is intended to be used in conjunction with endosseous implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdenture prostheses. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. Inclusive Titanium Abutment Blanks for Nobel Biocare are compatible with NobelActive Internal NP and RP implants. Inclusive Titanium Abutment Blanks for Institut Straumann are compatible with Straumann Bone Level implants in the NC and RC platform sizes. Inclusive Titanium Abutment Blanks for the Nobel Biocare Branemark System are compatible with the Branemark RP size implant. Abutments with angulations greater than 20 degrees on implants less than 4mm in diameter are not indicated for the posterior region because of strength limitations of the implant.

Device Story

Inclusive Titanium Abutment Blanks are titanium alloy components used by dental technicians to construct custom dental restorations. Device serves as interface between endosseous dental implant and final prosthesis (crown, bridge, or overdenture). Technician machines blank to patient-specific anatomy; screw-retained to implant. Used in dental laboratory settings. Provides structural support for prosthetic rehabilitation; enables cement-retained restorations. Benefits patient by facilitating customized, secure dental prosthetic attachment to implants.

Clinical Evidence

No clinical data. Effectiveness and safety are supported by the wide, general use of similar predicate devices and bench-level assessment of design and material suitability.

Technological Characteristics

Titanium alloy abutment blanks. Designed for screw-retention to endosseous implants. Compatible with specific Nobel Biocare (NobelActive Internal, Branemark) and Institut Straumann (Bone Level) implant platforms. Mechanical device; no software or energy source.

Indications for Use

Indicated for patients requiring prosthetic rehabilitation via endosseous dental implants in maxillary or mandibular arches. Supports crowns, bridges, or overdentures. Contraindicated for posterior region use if abutment angulation exceeds 20 degrees on implants <4mm diameter due to strength limitations.

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

• Nobel Biocare's Branemark (K042658)
• NobelActive Internal (K071370)
• Institut Straumann's (K062129)

Submission Summary (Full Text)

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K083192

## 510(k) Summary

MAK - 4 009

Inclusive Dental Solutions Submitter: 4141 MacArthur Blvd. Newport Beach, CA 92660

> Contact Person(s): Keith D. Allred, 949-440-2683 (phone) / 949-440-2787 (fax) and consultants, Greg Minzenmayer & Grant Bullis

Date of Application: October 21, 2008

Device Name:

- Trade Name Inclusive Titanium Abutment Blanks
- · Common Name Endosseous dental implant abutments
- · Classification II
- · Product Code NHA

Description: The device is comprised of titanium alloys. The device is designed to be screw-retained for use with Endosseous dental implants as an aid in prosthetic rehabilitation.

Intended Use: The device is indicated for use by dental technicians in the construction of custom made dental restorations that are supported by endosseous dental implants.

Substantial Equivalence: The device is substantially equivalent to other legally . marketed devices in the United States. Substantially equivalent devices include the following: Nobel Biocare's Branemark (K042658) and NobelActive Internal (K071370) implants, and Institut Straumann's (K062129) implants.

Safety and Efficacy: The device functions in a similar manner to other comparative devices and the intended use is the same. The differences between comparative devices are minor and do not raise new safety concerns. The effectiveness and suitability to the intended purpose of the device is assured through wide, general use of similar other predicate devices, and demonstrates the safe use of the device to construct dental restorations.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Keith D. Allred Official Correspondent Inclusive Dental Solutions 4141 MacArthur Boulevard Newport Breach, California 92660

MAR - 4 2009

Re: K083192

Trade/Device Name: Inclusive Titanium Abutment Blanks Regulation Number: 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: February 6, 2009 Received: February 9, 2009

Dear Mr. Allred:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely vours.

Suiste Y. Michie Davis -

Ginette Y. Michaud, M.D. Acting 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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## Schedule B

## Indications for Use Statement

510(k) Number: K083192

Device Name: Inclusive Titanium Abutment Blanks

Indications for Use:

The Inclusive Titanium Abutment Blank is intended to be used in conjunction with endosseous implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdenture prostheses. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

Inclusive Titanium Abutment Blanks for Nobel Biocare are compatible with NobelActive Internal NP and RP implants. Inclusive Titanium Abutment Blanks for Institut Straumann are compatible with Straumann Bone Level implants in the NC and RC platform sizes. Inclusive Titanium Abutment Blanks for the Nobel Biocare Branemark System are compatible with the Branemark RP size implant.

Abutments with angulations greater than 20 degrees on implants less than 4mm in diameter are not indicated for the posterior region because of strength limitations of the implant.

Prescription Use _ X (Part 21 CFR 801 SubpartD) AND/OR

Over-The-Counter Use (21 CFR 801 SubpartC)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Russo

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

510(k) Number: KCF3182