Straumann Dental Implant System

K171784 · Straumann USA, LLC · DZE · Jan 19, 2018 · Dental

Device Facts

• Record ID: K171784
• Device Name: Straumann Dental Implant System
• Applicant: Straumann USA, LLC
• Product Code: DZE · Dental
• Decision Date: Jan 19, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K171784 · Jan 19, 2018	Straumann Dental Implant System	Straumann USA, LLC	Published clinical literature	A literature review was conducted to evaluate implant survival rates in patients with Type II Diabetes Mellitus and patients with a history of head and neck radiation, supporting the removal of these conditions from the Cautions/Precautions section of the Instructions for Use.	Literature Review; Diabetes Mellitus; Head and Neck Radiation; Implant Survival Rate

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Literature review of Straumann implants in patients with Type II Diabetes Mellitus; Literature review	Patients with Type II Diabetes Mellitus (HbA1c levels 6-12%)	Non-diabetic patients	Implant survival rate, adverse events
Literature review of Straumann implants in patients with previously irradiated head and neck bone; Literature review; Follow-up/Duration: Up to 5 years	Patients with previously irradiated bone for oral cancer	Not applicable for this study	Implant survival rate

Indications for Use

Straumann® Dental implants are indicated for oral endosteal implantation in the upper and lower jaw arches and for the functional and aesthetic oral rehabilitation of edentulous and partially dentate patients. Straumann® Dental implants are also indicated 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 through the corresponding components (abutments).

Device Story

System of endosseous dental implants, abutments, and surgical/prosthetic instruments; used by dental clinicians for oral rehabilitation. Implants are surgically placed into the jawbone to support single crowns, bridges, or dentures. Roxolid® (titanium-zirconium alloy) or Grade 4 titanium implants feature a sandblasted, acid-etched surface; SLActive® variants are chemically activated and stored in NaCl solution. Device provides a stable foundation for prosthetic restoration, restoring chewing function and aesthetics. Clinical benefit includes predictable treatment outcomes for patients, including those with Type II Diabetes or history of head/neck radiation.

Clinical Evidence

No new clinical trials conducted. Evidence consists of a literature review of published studies regarding Straumann implant performance in patients with Type II Diabetes Mellitus and patients with prior head/neck radiation. Studies reported survival rates of 96.6%-100% for Type II Diabetes patients and 90%-100% for irradiated patients (up to 5 years post-placement).

Technological Characteristics

Solid screw-type endosseous implants; materials: titanium-zirconium alloy (Roxolid®) or titanium Grade 4. Surface: large-grit sandblasted and acid-etched. SLActive® surface is chemically activated and stored in NaCl solution. Sterilization processes are identical to predicate devices.

Indications for Use

Indicated for edentulous and partially dentate patients requiring oral endosteal implantation in upper or lower jaw arches for functional and aesthetic rehabilitation. Suitable for immediate or early implantation post-extraction/tooth loss. Supports single or multiple-tooth applications with immediate function if primary stability and occlusal loading conditions are met.

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

• Straumann® Dental Implant System (K130222)

Reference Devices

• Straumann® Bone Level Tapered Implants (K140878)
• Straumann® Bone Level Tapered Implants (K153758)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the words "U.S. Food & Drug Administration" on the right. The Department of Health & Human Services logo is a stylized representation of a human figure, while the FDA text is in a blue sans-serif font.

January 19, 2018

Straumann USA, LLC Jennifer Jackson Director, Regulatory Affairs & Quality 60 Minuteman Road Andover, Massachusetts 01810

Re: K171784

Trade/Device Name: Straumann® Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: December 19, 2017 Received: December 20, 2017

Dear Jennifer Jackson:

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.

{1}------------------------------------------------

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 of medical device-related adverse events) (21 CFR 803); 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.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Mary S. Runner -S

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known)

K171784

Device Name

Straumann® Dental Implant System

#### Indications for Use (Describe)

Straumann® Dental implants are indicated for oral endosteal implantation in the upper and for the functional and aesthetic oral rehabilitation of edentulous and partially dentate patients. Straumann® Dental implants are also indicated for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-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 through the corresponding components (abutments).

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

| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> |
|-------------------------------------------------------------------------------------------------|
| <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Straumann® Dental Implant System

510(k) Summary

#### 510(k) Summary K171784 5

#### Submitter 5.1

Straumann USA, LLC (on behalf of Institut Straumann AG)

60 Minuteman Road

Andover, MA 01810

Contact Person: Jennifer M. Jackson, MS

Phone Number: 1-978-747-2509

Fax Number: 1-978-747-0023

Date of Submission: January 19, 2018

### 5.2 Device

| Trade Name: | Straumann® Dental Implant System |
|----------------------|----------------------------------|
| Common Name: | Dental Implants |
| Classification Name: | Implant, Endosseous, Root-form |
| Regulatory Class: | DZE |
| Product Code: | Class II (21 CFR 872.3640) |

### 5.3 Predicate Device

Straumann® Dental Implant System (K130222) Primary Predicate: Reference Predicate: Straumann® Bone Level Tapered Implants (K140878) Straumann® Bone Level Tapered Implants (K153758)

#### Device Description 5.4

The Straumann® Dental Implant System is an integrated system of endosseous dental implants with corresponding abutments, healing abutments, closure screws and surgical and prosthetic parts and instruments.

The Straumann® Dental Implant System includes the following dental implants:

SLActive® and Roxolid®, Standard, Ø3.3 RN, 8, 10, 12, 14, and 16 mm

{4}------------------------------------------------

## Straumann® Dental Implant System

510(k) Summary

SLActive® and Roxolid®, Standard, Ø4.1 RN, 6, 8, 10, 12, 14, and 16 mm SLActive® and Roxolid®, Standard, Ø4.8 RN, 6, 8, 10, 12, and 14 mm SLActive® and Roxolid®, Standard, Ø4.8 WN, 6, 8, 10, and 12 mm SLActive® and Roxolid®, Standard Plus, Ø3.3 RN, 8, 10, 12, and 14 mm SLActive® and Roxolid®, Standard Plus, Ø4.1 RN and Ø4.8 RN, 6, 8, 10, 12, and 14 mm SLActive® and Roxolid®, Standard Plus, Ø4.8 WN, 6, 8, 10, 12, and 14 mm SLActive® and Roxolid®. Tapered Effect. Ø3.3 RN and Ø4.1 RN, 8. 10. 12. and 14 mm SLActive® and Roxolid®, Tapered Effect, Ø4.8 WN, 10, 12, and 14 mm SLActive® and Roxolid®, Bone Level, Ø3.3 NC, Ø4.1 RC, and Ø4.8 RC, 8, 10, 12, and 14 mm SLActive® and Roxolid®, Bone Level Tapered, Ø3.3 NC, Ø4.1 RC, and Ø4.8 RC, 8, 10,

12, 14, and 18 mm

### 5.5 Indications for Use

Straumann® Dental implants are indicated for oral endosteal implantation in the upper and lower jaw arches and for the functional and aesthetic oral rehabilitation of edentulous and partially dentate patients. Straumann® Dental implants are also indicated for immediate or early implantation following extraction or loss of natural teeth. lmplants 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 through the corresponding components (abutments).

There are no changes to the Indication for Use being introduced as a result of this submission. The Indications for Use statement of the subject device is identical to that of the primary predicate.

#### Technological Characteristics 5.6

Straumann® Dental implants are solid screw implants manufactured from titaniumzirconium alloy (Roxolid®) or titanium Grade 4. The implant surface is large-grit

{5}------------------------------------------------

## Straumann® Dental Implant System

510(k) Summary

sandblasted and acid-etched. In addition, SLActive® is in a chemically activated state, which is preserved by storage in a NaCI solution.

The subject devices are identical to the corresponding Straumann predicate devices with respect to design, materials, surface treatments, fundamental operating principles, and sterilization processes and procedures. The change proposed in this premarket notification modifies the Instructions for Use for the Roxolid® SLActive® and Titanium SLActive® dental implants, removing Type II Diabetes and patients previously irradiated in the head and neck from the Cautions/Precautions in the Instructions for Use. There are no changes to or new surgical instruments or secondary components being introduced as a result of the proposed change.

### 5.7 Performance Data

The bench and animal performance testing previously submitted in support of the referenced Straumann predicate devices were conducted according to the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and continue to be representative of the performance of the subject devices.

A review and summarization of published literature regarding dental implant treatment in patients suffering from Diabetes Mellitus (DM) and patients previously irradiated in the head and neck area is being provided in support of the proposed change to the Instructions for Use content (Cautions / Precautions) of the subject device.

In patients with Type II Diabetes Mellitus, most analyzed reviews found no statistically significant difference in the implant failure rate in diabetic and non-diabetic patients. The studies with Straumann implants in general and SLActive implants in particular reported a survival rate between 96.6% and 100% for patients with Type II Diabetes Mellitus (HbA1c levels between 6 and 12%). The most common adverse events were rotational movement of the implant, tenderness or pain at the implant site, pain on rotation of the transgingival healing cap, and peri-implant mucositis.

For patients with previously irradiated bone for oral cancer, studies with Straumann implants in general and SLActive implants in particular reported survival rates of 90% or 100% up to 5 years after implant placement. Radiation doses ranged from 30-40 Gy to

{6}------------------------------------------------

## Straumann® Dental Implant System

510(k) Summary

72 Gy. The time between radio- and implant therapy ranged from 6-12 months. Where included in the studies, restoration was uneventful.

The available data indicate that use of Straumann® SLActive® Implants for dental implant therapy is a predictable treatment option for patients with irradiated bone in the head or neck area and patients suffering from Type II Diabetes Mellitus.

## 5.8 Conclusion

The documentation submitted in this premarket notification supports the proposed modification to the Instructions for Use of the Roxolid® SLActive® and Titanium SLActive® dental implants. The subject devices are substantially equivalent to the predicate devices.