INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM

K103194 · Intra-Lock International, Inc. · DZE · Apr 21, 2011 · Dental

Device Facts

• Record ID: K103194
• Device Name: INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM
• Applicant: Intra-Lock International, Inc.
• Product Code: DZE · Dental
• Decision Date: Apr 21, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Intra-Lock Dental Implant System has been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either the mandible or maxilla and to support removable or fixed prothesis, from single tooth replacement to full arch reconstruction. They are intended for immediate function on single and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore normal teeth functions.

Device Story

Intra-Lock Dental Implant System with Blossom is a screw-type endosseous dental implant; features cutting surfaces on threads; diameters 3.4mm to 6mm; straight or conic body designs; internal six-spline taperlock connection. Used by dental clinicians in clinical settings for surgical placement in jawbone to support prosthetic teeth. Device provides foundation for fixed or removable dental prostheses; enables restoration of chewing function. Clinician selects appropriate implant size/abutment based on patient anatomy; implants placed surgically; primary stability required for immediate loading. Benefits include restoration of normal dental function and aesthetics for edentulous patients.

Clinical Evidence

Bench testing only. Fatigue testing performed according to ISO 14801 to compare new Blossom thread design and angled abutments against predicate devices. Results demonstrated that fatigue properties of the new design are similar to the predicate.

Technological Characteristics

Material: Ti 6AL4V. Design: Screw-type with Blossom cutting surfaces on threads. Connection: Internal six-spline taperlock. Dimensions: 3.4mm to 6mm diameter. Sterilization: Not specified. Energy source: N/A (mechanical). Connectivity: N/A.

Indications for Use

Indicated for partially or fully edentulous patients requiring restoration in the mandible or maxilla. Supports removable or fixed prostheses, ranging from single tooth replacement to full arch reconstruction. Indicated for immediate function on single or multiple tooth applications when good primary stability and appropriate occlusal loading are achieved.

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

• Intra-Lock Dental Implant System (K021322)
• Certain dental implants (K063341)
• Nanotite dental implants (K072363)

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness

March 7, 2011

APR 2 1 2011

Submitted by: Jeff Sakoff

Address: Intra-Lock International 6560 West Rogers Circle Boca Raton, FL 33487

Telephone: [phone] Fax:

Classification Name: Endosseous Dental Implant 21 CFR 872.3640

Trade Name: Intra-Lock Dental Implant System with Blossom

Legally Marketed Device: K021322 Intra-Lock Dental Implant System, K063341 Certain dental implants and K072363 Nanotite dental implants

Device Description: The Intra-Lock Endosseous Dental Implant System with Blossom is a screw-type implant system with a cutting design that incorpoarates at least one cutting surface on each thread. It ranges in diameter from 3.4 to 6mm. The 3.4, 4, and 6mm have a straight body design and there is also a 4mm with a conic body design. The internal connection is a six-spline taperlock design. Abutments include straight, flat top (a wedge shape), o-ball, and 15° & 25° angled (4mm and 6mm only). Prosthetic interface varies with the width of the implant. The 3.4mm has a narrow interface, the 4mms have a standard interface and the 6mm has a wide interface. The angled abutments do not come in narrow interface because of the small diameter of the narrow interface implant.

Indications for Use: The Intra-Lock Dental Implant System has been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either the mandible or maxilla and to support removable or fixed prothesis, from single tooth replacement to full arch reconstruction. They are intended for immediate function on single and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore normal teeth functions.

Substantial Equivalence:

| | This device. | K021322 intra-<br>Lock | K072363 Certain | K063341 Certain |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | Internal six-<br>spline<br>taperlock<br>connection<br>with smaller | Internal six-<br>spline<br>taperlock<br>connection | Internal 12 point<br>hex connection with<br>smaller threading at<br>the top | Internal 12 point<br>hex connection<br>with smaller<br>threading at the top |
| | threading at the top | | | |
| Sizes | 3.4, 4.0, 4.0<br>conic, 6.0 | 3.5,3.75,4.0 | 3.25,3.75,4.0,5.0,6.0 | 3.25,3.75,4.0,5.0,6.0 |
| Material | Ti 6AL4V | CP Ti | Ti6Al4V | Ti6AL4V |
| Indication | The Intra-Lock<br>Dental Implant<br>System has<br>been designed<br>to restore<br>partially or<br>fully<br>edentulous<br>patients. The<br>implants have<br>been designed<br>to be used in<br>either the<br>mandible or<br>the maxilla<br>and to support<br>removable or<br>fixed<br>prosthesis,<br>from single<br>tooth<br>replacement<br>to full arch<br>reconstruction.<br>They are<br>intended for<br>immediate<br>function on<br>single and/or<br>multiple tooth<br>applications<br>when good<br>primary<br>stability is<br>achieved, with<br>appropriate<br>occlusal<br>loading, in<br>order to<br>restore normal<br>teeth<br>functions. | The Intra-Lock<br>Implant<br>System has<br>been designed<br>to restore<br>partially or<br>fully<br>edentulous<br>patients. The<br>implants have<br>been designed<br>to be used in<br>either the<br>mandible or<br>the maxilla<br>and to supprt<br>removable or<br>fixed<br>prosthesis,<br>from single<br>toothe<br>replacement<br>to full arch<br>reconstruction. | Intended for<br>surgical placement<br>in the upper or<br>lower jaw to<br>provide the means<br>for prosthetic<br>attachment in single<br>tooth restorations<br>and in partially or<br>fully edentulous<br>spans with multiple<br>single teeth utilizing<br>a delayed or<br>immediate loading<br>or as a terminal or<br>intermediary<br>abutment for fixed<br>or removable<br>bridgework, and to<br>retain<br>overdentures.<br>Intended for<br>immediate function<br>on single tooth<br>and/or multiple<br>tooth applications<br>when good primary<br>stabiliy is achieved,<br>with appropriate<br>occlusal labeling, in<br>order to restore<br>chewing function. | Intended for<br>surgical placement<br>in the upper or<br>lower jaw to<br>provide means for a<br>prosthesis<br>attachment in single<br>tooth restorations<br>and in partially or<br>fully edentulous<br>spans with multiple<br>single teeth, or as a<br>terminal or<br>intermediary<br>abutment for fixed<br>or removable<br>bridgework, and to<br>retain<br>overdentures. In<br>addition, when a<br>minimum of 4<br>implants,≥10mm in<br>length, are placed in<br>the mandible and<br>splinted in the<br>anterior region,<br>immediate loading<br>is indicated. |
| Cutting | Blossom | fluted | fluted | fluted |
| Design | | | | |
| Testing<br>Results | ISO 14801<br>fatigue test<br>successful | ISO 14801<br>fatigue test<br>successful | Unknown, not in<br>510k summary | Unknown, not in<br>510k summary |

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Testing: Fatigue testing according to ISO 14801 was done with both angled abutments in order to demonstrate the design changes did not change the fatigue properties. The fatigue properties of the new design are similar to those of the predicate device.

Substantial Equivalence: The Intra-lock dental implants with Blossom are updated versions of the Intralock dental implants. The design, materials, instructions for use and packaging are the same. The indications for use is a combination of the indications for K021322 and K072363. Some of the design changes made to the threading are similar to threading in K063341. Fatigue testing showed this new version of the Intra-lock dental implants with Blossom threads has very similar fatigue properties to the previous version of Intra-lock dental implants.

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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 eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

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

APR 2 1 2011

Re: K103194

Trade/Device Name: Intra-Lock Dental Implant System with Blossom Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: April 15, 2011 Received: April 18, 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 (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- Ms. Blackwell

Please be advised that I'DA'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,

Wh 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 (if known): K | 03194

Device Name: Intra-Lock Dental Implant System with Blossom

Indications for Use:

· The Intra-Lock Dental Implant System has been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either the mandible or maxilla and to support removable or fixed prothesis, from single tooth replacement to full arch reconstruction, They are intended for immediate function on single and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore normal teeth functions.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

RSbetz DDS for Dr. S. Renner

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

510(k) Number: K103194

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