Straumann Sterile Healing Solution

K161677 · Institut Straumann AG · NHA · Oct 7, 2016 · Dental

Device Facts

• Record ID: K161677
• Device Name: Straumann Sterile Healing Solution
• Applicant: Institut Straumann AG
• Product Code: NHA · Dental
• Decision Date: Oct 7, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Healing abutments, healing caps and closure screws are intended for use with the implants of the Straumann Dental Implant System to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Fixation caps are used to stabilize bone grafts in cases where bone augmentation is being performed in conjunction with implant placement.

Device Story

Straumann Sterile Healing Solution consists of healing abutments, healing caps, closure screws, and fixation caps; used with Straumann Dental Implant System. Devices protect implant internal configuration; maintain/form soft tissue during healing; stabilize bone grafts during augmentation. Operated by dental professionals in clinical settings. Devices are commercially pure grade 4 titanium; provided sterile via gamma irradiation. Subject devices include one-piece solid and two-piece assemblies. Not intended for immediate loading protocols; not for use with granular bone substitutes or dental membranes. Clinical benefit involves facilitating successful implant integration and soft tissue healing.

Clinical Evidence

Bench testing only. No animal or human clinical studies conducted. Evidence includes sterilization validation (ISO 11137), biocompatibility assessment (ISO 10993), and shelf-life validation (ASTM F1980).

Technological Characteristics

Commercially pure grade 4 Titanium per ISO 5832-2. One-piece solid and two-piece assemblies. Provided sterile via gamma irradiation (SAL 10^-6) per ISO 11137-2. Packaging: PETG blister tray with Tyvek lid stock. Shelf life validated per ASTM F1980.

Indications for Use

Indicated for patients requiring dental implant healing components to protect implant internal features, manage soft tissue during healing, or stabilize bone grafts during augmentation procedures in conjunction with Straumann Dental Implant System implants.

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

• Straumann Sterile Healing Solution (K130808)

Reference Devices

• Bone Level Implants (K062129)
• SMARTbuilder System (K120951)

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

October 7, 2016

Institut Straumann AG % Jennifer Jackson Director Of Regulatory Affairs And Quality Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810

Re: K161677

Trade/Device Name: Straumann Sterile Healing Solution Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: September 5, 2016 Received: September 9, 2016

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.

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 and Part 809); 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

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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 and Part 809), 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.

# Michael J. Ryan -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

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### Indications for Use

510(k) Number (if known) K161677

Device Name

Straumann® Sterile Healing Solution

Indications for Use (Describe)

Healing abutments, healing caps and closure screws are intended for use with the implants of the Straumann Dental Implant System to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Fixation caps are used to stabilize bone grafts in cases where bone augmentation is being performed in conjunction with implant placement.

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

|X 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 | K161677 |
|----|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG)<br>60 Minuteman Road<br>Andover, MA 01810 |
| | Contact Person: | Jennifer M. Jackson, MS<br>Director of Regulatory Affairs and Quality<br>[phone] |
| | Prepared By: | Christopher Klaczyk<br>Head of North American Regulatory Affairs<br>Institut Straumann AG<br>[phone] |
| | Date Prepared: | October 7, 2016 |
| | Product Code(s): | NHA (21 CFR 872.3630) |
| | Device Class: | II (21 CFR 872.3630) |
| | Classification Panel: | Dental |
| | Classification Name: | Endosseous dental implant abutment (21 CFR 872.3630) |
| | Proprietary Name: | Straumann® Sterile Healing Solution |
| | Predicate Device:: | K130808, Straumann® Sterile Healing Solution (Institut<br>Straumann) |
| | Reference Device(s): | K062129, Bone Level Implants (Institut Straumann)<br>K120951, SMARTbuilder System (Osstem Implant Co.) |
| | Device Description: | The Straumann Healing Abutments, Healing Caps, and Closure<br>Screws are intended for use with the implants of the Straumann<br>Dental Implant System (SDIS) to protect the inner features of<br>the implant and to maintain, stabilize and form the soft tissue<br>during the healing process. The devices are available in various<br>diameters and heights. They are also not intended for use in<br>immediate loading protocols; none of the devices of the<br>Straumann Sterile Healing Solution are indicated for use in<br>immediate loading protocols as they are intended to protect the<br>internal features of the implant during the healing phase.<br>When the implant has sufficient primary stability, the closure |
| | | caps and fixation caps are used as a means to retain a bone graft |

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used to augment the bone in the vicinity of the implant. These devices are not intended to be used with granular bone substitute materials or dental membranes.

The subject devices are identified in the table below.

| Article<br>Number | Description |
|-------------------|-----------------------------------------|
| 024.0000S | RC Healing Abutment, conical, Ø 4.5, H2 |
| 024.0001S | RC Healing Abutment, conical, Ø 4.5, H4 |
| 024.0002S | RC Healing Abutment, conical, Ø 4.5, H6 |
| 024.0003S | RC Healing Abutment, conical, Ø 6.0, H2 |
| 024.0004S | RC Healing Abutment, conical, Ø 6.0, H4 |
| 024.0005S | RC Healing Abutment, conical, Ø 6.0, H6 |
| 024.2100S | NC Closure Screw, H 0 |
| 024.2100S-04 | NC Closure Screw, H 0 (4-Pack) |
| 024.2105S | NC Closure Screw, H 0.5 |
| 024.2105S-04 | NC Closure Screw, H 0.5 (4-Pack) |
| 024.2220S | NC Closure & Fixation Cap, Ø 5.5mm, Ti |
| 024.4100S | RC Closure Screw, H 0 |
| 024.4100S-04 | RC Closure Screw, H 0 (4-Pack) |
| 024.4105S | RC Closure Screw, H 0.5 |
| 024.4105S-04 | RC Closure Screw, H 0.5 (4-Pack) |
| 024.4220S | RC Closure & Fixation Cap, Ø 5.5mm, Ti |
| 048.324S | NNC Closure Screw, H 0 |
| 048.324SV4 | NNC Closure Screw, H 0 (4-Pack) |
| 048.325S | NNC Closure Screw, H 0.5 |
| 048.325SV4 | NNC Closure Screw, H 0.5 (4-Pack) |
| 048.371SV4 | RN Closure Cap, H 0, Ti (4-Pack) |
| 048.373SV4 | RN Closure Cap, H 1.5 mm, Ti (4-Pack) |

Indications For Use: Healing abutments, healing caps and closure screws are intended for use with the implants of the Straumann Dental Implant System to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Fixation caps are used to stabilize bone grafts in cases where bone augmentation is being performed in conjunction with implant placement. Materials: The material for all Healing Abutments, Closure Caps and Closure Screws is commercially pure Titanium (grade 4)

conforming to ISO 5832-2.

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## Technological Characteristics:

A comparison of the relevant technological characteristics between the subject and primary predicate devices is provided in the table that follows.

| Feature | Primary Predicate Device<br>Straumann Sterile Healing Solution | Subject Devices<br>Straumann Sterile Healing Solution |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use<br>K130808 | Closure screws, healing caps, and healing<br>abutments, are intended for use with the<br>straumann dental implant system (sdis) to<br>protect the inner configuration of the<br>implant and maintain, stabilize and form<br>the soft tissue during the healing process.<br>Customizable healing abutments made of<br>peek are for use for up to six months. | Healing abutments, healing caps and<br>closure screws are intended for use with the<br>implants of the Straumann Dental Implant<br>System to protect the inner configuration of<br>the implant and maintain, stabilize and<br>form the soft tissue during the healing<br>process. Fixation caps are used to stabilize<br>bone grafts in cases where bone<br>augmentation is being performed in<br>conjunction with implant placement. |
| Indications For Use<br>K120951 | SMARTbuilder System is a metal (Non-<br>resorbable membrane) device intended for<br>use with a dental implant to stabilize and<br>support of bone graft in dento-alveolar<br>bony defect sites. | The Indications for Use differ with the<br>removal of the PEEK abutments. The<br>subject devices do not include PEEK<br>abutments and only include Titanium<br>abutments; therefore the modification of<br>the Indications for Use is acceptable as the<br>PEEK abutment limitation for 6 months<br>does not apply to the subject device |
| Compatible Implants | Straumann Bone Level implants having the<br>NC and RC implant-to-abutment interface<br>geometries.<br>Straumann Tissue Level implants having<br>the NNC, RN and WN implant-to-abutment<br>interface geometries. | Straumann Bone Level implants having the<br>NC and RC implant-to-abutment interface<br>geometries.<br>Straumann Tissue Level implants having<br>the NNC and RN implant-to-abutment<br>interface geometries. |
| Material | Commercially pure grade 4 Titanium<br>per ISO 5832-2 | Commercially pure grade 4 Titanium<br>per ISO 5832-2 |
| Construction | One-piece solid device. | One-piece solid devices and two-piece<br>device assemblies. Two-piece devices are<br>supported via comparison with components<br>of the Osstem SMARTbuilder System<br>(K120951) |
| Packaging | Primary barrier package consists of a<br>PETG blister tray with a PETG insert and a<br>Tyvek 1073B lid stock. The primary<br>package is contained within a paperboard<br>shelf box. | Primary barrier package consists of a<br>PETG blister tray with a PETG insert and a<br>Tyvek 1073B lid stock. The primary<br>package is contained within a paperboard<br>shelf box. |
| Sterility | Provided sterile via gamma irradiation to a<br>Sterility Assurance Level of 10-6.<br>Cycle validated per ISO 11137-2. | Provided sterile via gamma irradiation to a<br>Sterility Assurance Level of 10-6.<br>Cycle validated per ISO 11137-2. |

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| Performance Data: | Test data to support the evaluation of the subject closure cap<br>and fixation cap devices has been included directly or by<br>reference as follows:<br>Sterilization validation in accordance with ISO 11137 series of standards. Biocompatibility assessment per the ISO 10993 series of standards. Shelf Life validation in accordance ASTM F1980 |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | No animal or human clinical studies were conducted. |
| Conclusions: | Based upon our assessment of the design and applicable<br>performance data, the subject devices have been determined to<br>be substantially equivalent to the identified predicate devices. |