Straumann® Dental Implant System ¿ Roxolid® SLA Implants

K150938 · Straumann USA, LLC · DZE · Jul 24, 2015 · Dental

Device Facts

• Record ID: K150938
• Device Name: Straumann® Dental Implant System ¿ Roxolid® SLA Implants
• Applicant: Straumann USA, LLC
• Product Code: DZE · Dental
• Decision Date: Jul 24, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Straumann® dental implants are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. Straumann dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments).

Device Story

Straumann Dental Implant System - Roxolid SLA Implants are endosseous dental implants designed for oral rehabilitation. Implants are surgically placed into the upper or lower jaw by dental professionals. The device serves as an anchor for prosthetic restorations, including single crowns, bridges, and partial or full dentures, which are attached via abutments. The system utilizes Roxolid (Ti-13Zr alloy) and SLA (grit blast and acid etch) surface finish to facilitate osseointegration. The device is intended to restore chewing function and esthetics for patients with missing teeth. Clinical benefit is derived from the restoration of oral function and appearance through stable, long-term integration with jaw bone.

Clinical Evidence

Bench testing only. Evidence includes dynamic fatigue testing consistent with ISO 14801, transfer piece removal force data, and surface finish/chemistry analysis. No clinical data was required or provided.

Technological Characteristics

Implants composed of Ti-13Zr alloy (Roxolid) with SLA surface finish. Transfer pieces composed of Ti-6Al-7Nb alloy (ISO 5832-11). Available in various diameters (3.3mm, 4.1mm, 4.8mm) and lengths (6.0mm-16.0mm). Connections include Bone Level (NC, RC) and Tissue Level (NNC, RN, WN). Sterilization via Gamma Irradiation (min 25 kGy) to SAL 10^-6. Packaging includes styrene-butadiene block copolymer vials and polyamide implant holders.

Indications for Use

Indicated for oral endosteal implantation in edentulous or partially dentate patients requiring functional and esthetic oral rehabilitation. Suitable for immediate or early implantation post-extraction or tooth loss. Applicable for single or multiple tooth applications with immediate function, provided 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

• All in One Two Part Implant (Straumann) (K983742)
• Tapered Implant Modification (Straumann) (K012757)
• Standard Plus Implant (Straumann) (K033922)
• Bone Level Implants (Straumann) (K062129)
• NNC Roxolid Implant System (K111357)
• Bone Level Tapered Implants (K140878)

Reference Devices

• SLActive Surface Finish (K033984)
• Roxolid Tapered Effect Implants (Straumann) (K081419)
• Roxolid 3.3 Implants (Straumann) (K083550)
• Roxolid 4.1/4.8 Bone Level Implants (Straumann) (K121131)
• Roxolid 4.1/4.8 Tissue Level Implants (Straumann) (K122855)

Submission Summary (Full Text)

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

July 24,2015

Straumann USA, LLC Christopher Klaczyk Director of Regulatory and Clinical Affairs 60 Minuteman Road Andover, Massachusetts 01810

Re: K150938

Trade/Device Name: Straumann® Dental Implant System - Roxolid® SLA Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: June 19, 2015 Received: June 22, 2015

Dear Mr. Klaczyk:

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.

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

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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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Russo, DDS, MA

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, 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) K150938

Device Name

Straumann® Dental Implant System - Roxolid® SLA Implants

Indications for Use (Describe)

Straumann® dental implants are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. Straumann dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments).

Type of Use (Select one or both, as applicable)

|× Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 5. 510(k) Summary – K150938

| Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG)<br>60 Minuteman Road<br>Andover, MA 01810<br>Registration No.: 1222315 Owner/Operator No.: 9005052 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Christopher Klaczyk<br>Director of Regulatory and Clinical Affairs |
| Date Prepared: | July 13, 2015 |
| Product Code(s): | DZE (21 CFR 872.3640) |
| Device Class: | II<br>(21 CFR 872.3640) |
| Classification Panel: | Dental |
| Classification Name: | Endosseous dental implant (21 CFR 872.3640) |
| Proprietary Name: | Straumann® Dental Implant System ">– Roxolid® SLA Implants |
| Predicate Device(s) | This is a bundled 510(k) Premarket Notification. Each of the<br>predicates listed below is a primary predicate for a portion of<br>the subject devices of this submission.<br>K983742 - All in One Two Part Implant (Straumann)<br>K012757 - Tapered Implant Modification (Straumann)<br>K033922 - Standard Plus Implant (Straumann)<br>K062129 - Bone Level Implants (Straumann)<br>K111357 – NNC Roxolid Implant System<br>K140878 - Bone Level Tapered Implants |
| Reference Device(s) | K033984 - SLActive Surface Finish<br>K081419 - Roxolid Tapered Effect Implants (Straumann)<br>K083550 - Roxolid 3.3 Implants (Straumann)<br>K121131 – Roxolid 4.1/4.8 Bone Level Implants (Straumann)<br>K122855 - Roxolid 4.1/4.8 Tissue Level Implants (Straumann) |
| Device Description: | The subject devices represent a line extension of the previously<br>cleared implants of the Straumann Dental Implant System. The<br>subject devices represent a full line of Straumann implants<br>having the Ti-13Zr alloy (Roxolid®) and the SLA grit blast and<br>acid etch surface finish in the same diameters, lengths,<br>emergence profiles and implant-to abutment interfaces as<br>previously cleared implants in the Straumann Dental Implant<br>System. |

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Straumann® dental implants are indicated for oral endosteal Intended Use: implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. Straumann dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments).

- Materials: The subject devices will be produced from a titanium-13zirconium alloy, trade named Roxolid®, as previously reviewed and cleared to market per premarket notification submissions K111357 for the predicate devices, as well as K081419, K083550, K121131 and K122855 for the reference devices.
The transfer piece is produced from titanium-6aluminum-7niobium alloy (TAN) conforming to ISO 5832-11. This is the same material and design as for the predicate transfer pieces cleared to market per premarket notification submissions K140878.

- The subject devices have the same Indications For Use and the Technological Characteristics: same technical characteristics as the identified predicate and reference devices, with the exception of the material. Technological characteristics of the subject devices are compared with those of the predicate devices in the table below.

| Feature | Subject Devices<br>Roxolid SLA Implants | Predicate Devices<br>Titanium SLA Implants |
|-----------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Implant-to-Abutment<br>Connections:<br>Bone Level | Narrow CrossFit (NC) | Narrow CrossFit (NC) |
| | Regular CrossFit (RC) | Regular CrossFit (RC) |
| Implant-to-Abutment<br>Connections:<br>Tissue Level | Narrow Neck CrossFit® (NNC) | Narrow Neck CrossFit® (NNC) |
| | Regular Neck (RN) | Regular Neck (RN) |
| | Wide Neck (WN) | Wide Neck (WN) |
| Implant Diameter(s) | Ø3.3mm, Ø4.1mm, Ø4.8mm | Ø3.3mm, Ø4.1mm, Ø4.8mm |
| Implant Length(s) | 6.0, 8.0, 10.0, 12.0, 14.0, 16.0 mm<br>(6.0mm length excluded for Ø3.3mm) | 6.0, 8.0, 10.0, 12.0, 14.0, 16.0 mm<br>(6.0mm length excluded for Ø3.3mm) |
| Surface Finish | SLA | SLA |
| Material | Commercially pure Grade 4<br>Titanium | Titanium-13Zirconium alloy<br>(Roxolid®) |

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| Primary Package | Vial of styrene-butadiene block copolymer (Styrolux), vial cap of LDPE and an implant holder of Grilamid TR70 polyamide. | Vial of styrene-butadiene block copolymer (Styrolux), vial cap of LDPE and an implant holder of Grilamid TR70 polyamide. |
|-----------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Sterilization | Gamma Irradiation, 25 kGy min.<br>Validated per ISO 11137-1 and ISO 11137-2 to an SAL of $1 x 10^{-6}$ | Gamma Irradiation, 25 kGy min.<br>Validated per ISO 11137-1 and ISO 11137-2 to an SAL of $1 x 10^{-6}$ |

Performance Data: Per Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments dated May 12, 2004, the substantial equivalence of the subject device(s) are satisfactorily addressed via bench studies. Dynamic fatigue test data consistent with FDA guidance and ISO 14801 have been referenced in support of this submission. Transfer Piece removal force data has been provided. Surface finish characteristics and surface chemistry analysis data have also been provided.

- Conclusions: Based upon our assessment of the design and applicable performance data, the subject devices have been determined to be substantially equivalent to the identified predicate devices.