INCLUSIVE IMPLANT ABUTMENTS

K073217 · Inclusive Dental Solutions · NHA · May 14, 2008 · Dental

Device Facts

• Record ID: K073217
• Device Name: INCLUSIVE IMPLANT ABUTMENTS
• Applicant: Inclusive Dental Solutions
• Product Code: NHA · Dental
• Decision Date: May 14, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

The Inclusive Abutment 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. The Inclusive Abutment for Zimmer Implant is compatible with Zimmer Screw Vent and Tapered Screw Vent internal hex implants. The Inclusive Abutment for 3i Implant is compatible with 3i Certain internal hex implants. The Inclusive Abutment for Nobel Biocare Implant is compatible with Nobel Biocare Replace straight and tapered internalconnection implants. Please note: This device may be used in an early load situation, dependent on the specific implant system and protocol used by the dental professional; and, highly angled abutments (i.e. 20 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.

Device Story

Inclusive™ Implant Abutment; titanium alloy component; screw-retained to endosseous dental implants. Used by dental technicians to construct custom dental restorations (crowns, bridges, overdentures). Compatible with specific Zimmer, 3i, and Nobel Biocare internal hex implant systems. Provides structural support for prosthetic rehabilitation. Clinical benefit: enables secure attachment of dental prostheses to implants. No complex electronics or software involved.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison to legally marketed predicate devices.

Technological Characteristics

Constructed from titanium alloys. Designed as screw-retained abutments for internal hex endosseous dental implants. Mechanical device; no energy source, software, or connectivity. Sterilization method not specified.

Indications for Use

Indicated for patients requiring prosthetic rehabilitation in the maxillary or mandibular arch. Used by dental technicians to support crowns, bridges, or overdentures via endosseous implants. Contraindicated for highly angled abutments (20 degrees) on implants <4mm diameter in the posterior region due to limited implant strength.

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

• 3i (K063341, K072642)
• Nobel Biocare (K042658, K022425, K041275)
• Zimmer (K061847, K071439)

Submission Summary (Full Text)

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# 1073217

### 510(k) Summary

MAY 1 4 2008

Submitter: Inclusive Dental Solutions 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, 2007 (Revised April 22, 2008)

Device Name:

- · Trade Name Inclusive™ Implant Abutment
- · 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: 3i (K063341, K072642), Nobel Biocare (K042658, K022425, K041275), and Zimmer (K061847, K071439).

Safety and Efficacy: The device functions in a similar manner to other comparative devices and the intended use is the same. The differences between comperative 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 consists of a stylized eagle with three overlapping wing-like shapes, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 1 4 2008

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

Re: K073217

Trade/Device Name: Inclusive™ Abutment for Zimmer, 3i and Nobel Biocare Implants Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: April 23, 2008 Received: April 15, 2008

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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## Page 2 – Mr. Allred

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 (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.

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.

CARS

Chiu Lin. Ph.D. 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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#### Schedule B

#### Indications for Use Statement

510(k) Number: K073217

Device Name: Inclusive™ Abutment for Zimmer, 3i and Nobel Biocare Implants

Indications for Use:

The Inclusive Abutment 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.

The Inclusive Abutment for Zimmer Implant is compatible with Zimmer Screw Vent and Tapered Screw Vent internal hex implants. The Inclusive Abutment for 3i Implant is compatible with 3i Certain internal hex implants. The Inclusive Abutment for Nobel Biocare Implant is compatible with Nobel Biocare Replace straight and tapered internalconnection implants.

Please note: This device may be used in an early load situation, dependent on the specific implant system and protocol used by the dental professional; and, highly angled abutments (i.e. 20 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength 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 Runse

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

510(k) Number: KC73217