STRAUMANN DENTAL IMPLANT SYSTEM

K130222 · Straumann USA, LLC · DZE · Apr 29, 2013 · Dental

Device Facts

• Record ID: K130222
• Device Name: STRAUMANN DENTAL IMPLANT SYSTEM
• Applicant: Straumann USA, LLC
• Product Code: DZE · Dental
• Decision Date: Apr 29, 2013
• 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 arches 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

Straumann Dental Implant System (SLActive and Roxolid families) consists of endosseous root-form implants placed in upper/lower jaw arches; used by dental professionals for functional/aesthetic rehabilitation of edentulous/partially dentate patients. Implants support single crowns, bridges, or dentures via abutments. Device allows immediate/early implantation post-extraction and immediate function if primary stability is achieved. Clinical benefit includes restored chewing function and aesthetics. This submission specifically modifies indications to remove the requirement for at least four implants when treating fully edentulous patients with immediate loading, supported by consensus statements (McGill/York) favoring two-implant restoration.

Clinical Evidence

No new clinical trials were conducted. Evidence consists of a review of clinical literature and consensus statements (American Dental Association, McGill Consensus, York Consensus) supporting the use of two immediately loaded dental implants for fully edentulous patients. Literature indicates that two-implant restoration is a common, effective treatment and is equivalent to using a greater number of implants for this indication.

Technological Characteristics

Endosseous root-form dental implants. Materials, surface treatments (SLActive/Roxolid), and fundamental operating principles are identical to predicate devices. No changes to surgical instruments or secondary components. Sterilization procedures remain unchanged.

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 or tooth loss. Supports immediate function for single or multiple tooth applications provided 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

• K033922, Modification to ITI Dental Implant System
• K033984, ITI Dental Implant System
• K053088, SLActive Implants
• K062129, P.004 Implants
• K081419, Modified Dental Implant
• K083550, Modified Dental Implant
• K111357, Narrow Neck CrossFit (NNC) Ø3.3 mm Dental Implant System
• K121131, Straumann Bone Level Ø4.1 mm and Ø4.8 mm Regular Connection (RC) Roxolid Dental Implants
• K122855, Straumann Tissue Level Ø4.1 mm and Ø4.8 mm Roxolid Dental Implants
• K123784, Straumann Dental Implant System - SLA, SLActive and Roxolid Product Families

Submission Summary (Full Text)

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# K1302222

# Traditional 510(k) Submission.

Change in Straumann Dental Implant Indications for Use

APR 2 9 2013

#### 5. 510(k) Summary

#### Submitter's Contact Information 5.1

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

60 Minuteman Road

Andover, MA 01810

| Contact Person: | Jennifer M. Jackson, MS or | Christopher Klaczyk |
|-----------------|----------------------------|---------------------|
| Phone Number: | 1-978-747-2509 | 1-978-747-2575 |
| Fax Number: | 1-978-747-0023 | 1-978-747-0023 |

Date of Submission: 28-Jan-2013

#### 5.1 Name of the Device

| Trade Name: | Straumann® Dental Implant System |
|-------------|---------------------------------------|
| | SLActive and Roxolid Product Families |

Common Name: Dental Implants

Classification Name: Implant, Endosseous, Root-form

Regulation Number: §872.3640

#### 5.2 Predicate Device(s)

K033922, Modification to ITI Dental Implant System

K033984, ITI Dental Implant System

K053088, SLActive Implants

K062129, P.004 Implants

K081419, Modified Dental Implant

K083550, Modified Dental Implant

K111357, Narrow Neck CrossFit (NNC) Ø3.3 mm Dental Implant System

K121131, Straumann Bone Level Ø4.1 mm and Ø4.8 mm Regular Connection (RC) Roxolid Dental Implants

K122855, Straumann Tissue Level Ø4.1 mm and Ø4.8 mm Roxolid Dental Implants

K123784, Straumann Dental Implant System - SLA, SLActive and Roxolid Product Families

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# Traditional 510(k) Submission

Change in Straumann Dental Implant Indications for Use

#### Device Description 5.3

The subject devices of the Straumann® Dental Implant System includes the following: SLActive® and Roxolid®, Standard, Ø3.3 RN, 8, 10, 12, 14 & 16 mm SLActive® and Roxolid®, Standard, Ø4.1 RN, 6, 8, 10, 12, 14 & 16 mm SLActive® and Roxolid®, Standard, Ø4.8 RN, 6, 8, 10, 12 & 14 mm SLActive® and Roxolid®, Standard, Ø4.8 WN, 6, 8, 10 & 12 mm SLActive® and Roxolid®, Standard Plus, Ø3.3 RN, 8, 10, 12 & 14 mm SLActive® and Roxolid® Standard Plus, Ø4.1 RN and Ø4.8 RN, 6. 8. 10. 12 & 14 mm SLActive® and Roxolid®, Standard Plus, Ø4.8 WN, 6, 8, 10, & 12 mm Roxolid®, Standard Plus, Ø4.8 WN, 14 mm SLActive® and Roxolid®, Tapered Effect, Ø3.3 RN and Ø4.1 RN, 8, 10, 12 & 14 mm SLActive® and Roxolid®, Tapered Effect, Ø4.8 WN, 10, 12 & 14 mm SLActive® and Roxolid®, Bone Level, Ø3.3 NC, Ø4.1 RC, and Ø4.8 RC, 8, 10, 12 & 14 mm

#### 5.4 Indications For Use / Intended Use

Straumann® Dental implants are indicated for oral endosteal implantation in the upper and lower jaw arches 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).

#### 5.5 Technological Characteristics

The subject devices are identical to the corresponding Straumann predicate devices as far as design, materials, surface treatments, fundamental operating principles, and sterilization processes and procedures. The change proposed in this premarket notification modifies the Indications for Use for the SLActive® and Roxolid® dental implants.

There are no changes to or new surgical instruments or secondary components being introduced as a result of the proposed change.

#### 5.6 Performance Testing

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: Rootform Endosseous Dental Implants and Endosseous Dental Abutments" and continues to be representative of the performance of the subject devices.

A review and summarization of the clinical literature associated with the use of two immediately loaded dental implants in the treatment of fully edentulous patients. The available data indicate that the use of two dental implants to treat fully edentulous patients is common; the evidence supports that performance of two immediately loaded dental implants is equivalent to the use of a greater number of implants for this indication. We also provide

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## Change in Straumann Dental Implant Indications for Use

consensus statements from the American Dental Association, the McGill Consensus and the York Consensus indicating that two implant restoration of fully edentulous mandibles should be the treatment of choice. This literature strongly supports the elimination of the limitation requiring the use of at least four dental implants for the treatment of the fully edentulous patient when the implants are to be immediately loaded.

#### 5.7 Conclusion

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

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the eagle.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

## April 29, 2013

Ms. Jennifer M. Jackson, MS Senior Regulatory Affairs Project Manager Straumann USA, Limited Liability Company 60 Minuteman Road ANDOVER MA 01810

Re: K130222

Trade/Device Name: Straumann® Dental Implant System SLActive and Roxolid Product Families Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: January 28, 2013 Received: January 29, 2013

Dear Ms. 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.

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21-GFR-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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/Medica!Devices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kwame O. Ulmer -S for

Anthony D. Watson, B.S., M.S., M.B.A. 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); K130222

Device Name:

Straumann® Dental Impiant System SLActive and Roxolid Product Families

### Indications for Use:

Straumann® Dental implants are indicated for oral endosteal implantation in the upper and lower jaw arches 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).

Prescription Use X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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) |
|--------------------------------------------------------|
|--------------------------------------------------------|

| | Digitally signed by Mary S. Runner - S |
|--|----------------------------------------|
| | ON: c=US, o=U.S. Government, |
| | ou=HHS, ou=FDA, ou=People, |
| | cn=Mary S. Runner - S, |
| | 0.9.2342.19200300.100.1.1=13000879 |
| | Date: 2013.04.29 09:55:02 -04'00' |

Susan Runner, DDS, DA

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

510(k) Number:

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