INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM 3.4MM IMPLANT ANGLED ABUTMENTS

K111199 · Intra-Lock International, Inc. · NHA · Aug 8, 2011 · Dental

Device Facts

• Record ID: K111199
• Device Name: INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM 3.4MM IMPLANT ANGLED ABUTMENTS
• Applicant: Intra-Lock International, Inc.
• Product Code: NHA · Dental
• Decision Date: Aug 8, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

Intra-Lock® 15° Angled Abutments are intended for use with Intra-Lock® dental implants to support a prosthetic device in partially or fully edentulous patients. The abutments may be used in single and/or multiple tooth application in the mandible or maxilla.

Device Story

Intra-Lock® 15° Angled Abutment is a dental implant component designed to connect an endosseous dental implant to a prosthetic device. It features a narrow prosthetic interface (SQ Platform) and is anodized magenta. Used by dental professionals in clinical settings, the abutment provides an angled connection to support dental prosthetics in the mandible or maxilla. It functions as a mechanical interface to restore tooth function in edentulous patients. The device is installed by a clinician during dental implant procedures.

Clinical Evidence

Bench testing only. Static and dynamic fatigue testing performed in accordance with ISO 14801:2007.

Technological Characteristics

Endosseous dental implant abutment with 15° angle. Features narrow prosthetic interface (SQ Platform). Anodized magenta. Mechanical testing performed per ISO 14801:2007.

Indications for Use

Indicated for partially or fully edentulous patients requiring prosthetic support via dental implants in the mandible or maxilla for single or multiple tooth applications.

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

• Intra-Lock® Dental Implant System with Blossom (K103194)

Submission Summary (Full Text)

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AUG - 8 2011

Image /page/0/Picture/2 description: The image shows the logo for INTRA-LOCK International. The logo is in black and white, with the words "INTRA-LOCK" in large, bold letters. Below that, the word "INTERNATIONAL" is written in smaller letters. To the left of the words is a square shape with a U-shaped design inside.

#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

| Submitter's Name: | Intra-Lock International<br>6560 West Rogers Circle<br>Boca Raton, FL 33487 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone: | [phone] |
| Facsimile: | [phone] |
| Contact Person: | Diana Taylor |
| Date Prepared: | August 4, 2011 |
| Name of Device: | Intra-Lock® 15° Angled Abutment |
| Common Name: | 15° Angled Abutment |
| Classification Name: | Endosseous Dental Implant Abutment 21 CFR 872.3630 |
| Predicate Devices: | K103194, Intra-Lock® Dental Implant System with<br>Blossom |
| Intended Use/Indications: | Intra-Lock® 15° Angled Abutments are intended for use<br>with Intra-Lock® dental implants to support a prosthetic<br>device in partially or fully edentulous patients. The<br>abutments may be used in single and/or multiple tooth<br>application in the mandible or maxilla. |

Technological Characteristics: The subject Intra-Lock® 15° Angled Abutment has a narrow prosthetic interface (SQ Platform) and therefore only mates with implants having SQ Platform. The SQ Platform abutments are anodized a magenta color.

Mechanical Testing: The subject Intra-Lock® 15°Angled Abutment had static and dynamic fatigue testing performed in accordance with ISO 14801:2007 and submitted in this 510(k).

Substantial Equivalence: The subject Intra-Lock® 15°Angled Abutment has the same basic design, and technological characteristics, identical materials, intended use / indications, principles of operation, instructions for use and packaging as the predicate devices in K103194. The minor differences between the subject Intra-Lock® 15°angled abutment and it's predicate(s) raise no new issues of safety or effectiveness. Therefore, the subject Intra-Lock® 15°angled abutment is substantially equivalent to the predicate abutments.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which includes an abstract representation of a human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem.

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

Intra-Lock International, Incorporated C/O Ms. Angela Blackwell Senior Consultant Biologics Consulting Group 6560 West Rogers Circle Boca Raton, Florida 33487

AUG - 8 2011

Re: K111199

Trade/Device Name: Intra-Lock® 15° Angled Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: July 28, 2011 Received: July 29, 2011

Dear Ms. Blackwell:

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 ffor 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 - Ms. Blackwell

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 /ugm115809.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 CDRFF'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/ResourcesforYou/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

### Enclosure

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# Indications for Use

510(k) Number: K111199

Device Name: Intra-Lock® 15° Angled Abutment

Indications for Use:

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Intra-Lock® 15° Angled Abutments are intended for use with Intra-Lock® dental implants to support a prosthetic device in partially or fully edentulous patients. The abutments may be used in single and/or multiple tooth application in the mandible or maxilla.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: