Straumann® Anatomic Healing Abutments XC (AHA)

K241575 · Straumann USA, LLC · NHA · Nov 11, 2024 · Dental

Device Facts

• Record ID: K241575
• Device Name: Straumann® Anatomic Healing Abutments XC (AHA)
• Applicant: Straumann USA, LLC
• Product Code: NHA · Dental
• Decision Date: Nov 11, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

Straumann sterile healing components are intended for use with implants of the Straumann Dental Implant System (SDIS) to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process.

Device Story

Straumann Anatomic Healing Abutments (AHA) are two-piece, screw-retained components for use with Straumann Dental Implant System (SDIS) implants. The device consists of a PEEK Classix body and a Titanium-Aluminum-Niobium (TAN) alloy basal screw. Used during implant placement or reopening surgery, the AHA protects the implant's inner configuration and shapes soft tissue during the osseointegration phase. The body is customizable chairside by dental professionals using manual milling instruments, provided a 4.7mm central area remains intact to preserve scanning functionality. The device features dots on the occlusal surface that can be visualized in STL files via intraoral scanners to represent implant position, axis, and orientation. The AHA is placed out of occlusion and removed before final prosthetic restoration. It is intended for temporary use up to 180 days. The device benefits patients by facilitating soft tissue healing and providing digital scan data for subsequent prosthetic planning.

Clinical Evidence

Bench testing only. Testing included torque testing for insertion/removal, sterilization validation (ISO 11137-1/2, ISO 17665-1), biocompatibility (ISO 10993-1, including cytotoxicity and chemical extraction), and software integration testing for intraoral scanning compatibility.

Technological Characteristics

Two-piece screw-retained design. Body: PEEK Classix (ASTM F2026). Basal Screw: Titanium-Aluminum-Niobium (TAN) alloy (ISO 5832-11). Diameters: 3.8mm, 4.5mm, 5.5mm, 6.5mm. Sterilization: Gamma radiation (sterile); steam sterilization (if customized). Connectivity: Intraoral scanning via visual identification dots in STL files. Interface: Straumann TorcFit.

Indications for Use

Indicated for partially edentulous patients after implant placement to protect the inner configuration of the implant and form, maintain, and stabilize soft tissue during the healing process. Maximum duration of use is 180 days.

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 Healing Abutments (K130808)

Reference Devices

• BellaTek Encode Emergence Healing Abutment (K212730)
• Protective caps of the Straumann Magellan Abutment System (K133421)
• Straumann BLX Basal Screws (K173961)
• MRI Compatibility for Existing Straumann Dental Implant Systems (K190662)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 11, 2024

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

Re: K241575

Trade/Device Name: Straumann® Anatomic Healing Abutments XC (AHA) Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: October 24, 2024 Received: October 25, 2024

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Andrew I. Steen -S

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

Submission Number (if known)

K241575

Device Name

Straumann® Anatomic Healing Abutments XC (AHA)

#### Indications for Use (Describe)

Straumann® Anatomic Healing Abutments are indicated to be placed in partially edentulous patients after implant placement. The healing components protect the inner configuration of the implant and form, maintain and stabilize the soft tissue during the healing components have a maximum duration of usage of 180 days.

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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# Straumann Anatomic Healing Abutments XC (AHA)

### K241575

### Submitter's Contact Information

| Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG) |
|-------------------------------------|----------------------------------------------------------------------------------------------|
| | 60 Minuteman Road |
| | Andover, MA 01810 |
| | Registration No.: 1222315Owner/Operator No.: 9005052 |
| | On the behalf of: |
| | Institut Straumann AG |
| | Peter Merian weg 12 |
| | Basel BS CH-4002 Switzerland |
| Contact Person: | Jennifer M. Jackson, MS, RAC |
| | Sr. Director, Regulatory Affairs and Quality |
| | Phone Number: [phone] |
| | Fax Number: [phone] |
| Prepared By &<br>Alternate Contact: | Laura Bleyendaal<br>Sr. RA Specialist<br>Straumann USA, LLC<br>Phone number: [phone] |
| Date of Submission: | November 5, 2024 |
| Name of the Device | |
| Trade Names: | Straumann Anatomic Healing Abutments XC (AHA) |
| Common Name: | Abutment, Implant, Dental, Endosseous |
| Classification Name: | Endosseous dental implant abutment |
| Regulation Number: | §872.3630 |
| Device<br>Classification: | II |

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# Straumann Anatomic Healing Abutments XC (AHA)

K241575

Product Code(s): NHA

Classification Panel: Dental

### Predicate Device(s)

Primary Predicate:

- Straumann Healing Abutments (K130808) .
Reference Devices:

- BellaTek Encode Emergence Healing Abutment (K212730) .
- Protective caps of the Straumann Magellan Abutment System (K133421) .
- Straumann BLX Basal Screws (K173961) .
- . MRI Compatibility for Existing Straumann Dental Implant Systems (K190662)

### Device Description

The Straumann Anatomic Healing Abutments XC (referred to as the AHAs) are intended for use with the Straumann Dental Implant System (SDIS). The healing components protect the inner configuration of the implant and form, maintain, and stabilize the soft tissue during the osseointegration phase of Straumann endosseous dental implants to be rehabilitated using the delayed loading technique. The AHA are to be used during the implant placement surgery or in the reopening surgery (second surgical phase) and are for temporary use up to 180 days. The AHAs are to be placed out of occlusion. The healing abutments do not support a prosthetic restoration.

The AHAs are composed of two united parts: a body that allows for customization and includes a through hole for fixation screw access, and a basal screw that cannot be altered. The Anatomic Healing Abutments are intended to be customized using only hand milling instruments manually controlled by dental professionals. To protect the consistent emergence profile for final abutment, a maximum 3mm height can be modified down to the occlusal surface. To preserve the scanning function of AHA, a

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# Straumann Anatomic Healing Abutments XC (AHA)

### K241575

4.7mm circular area around the central axis of the screw channel cannot be modified. Figure 1 depicts, in green, the customizable areas on an AHA. The body is milled from polyetheretherketone (PEEK Classix). The basal screws are existing basal screws manufactured from Titanium-Aluminum-Niobium (TAN) alloy previously cleared as part of the Straumann BLX system in K173961.

Image /page/6/Picture/4 description: The image shows a dental implant. The implant is made of metal and has a screw-like shape. The implant is inserted into the jawbone to replace a missing tooth. The image also shows the abutment, which is the part of the implant that connects to the crown.

Figure 1. Representative image of an AHA connected to a BLX implant. The green area may be customized whereas the red area is not to be customized.

The AHA are designed for connection to BLC and BLX implants of the Straumann Dental Implant System (K173961, K181703, K191256, K210855, K212533, K230108, and K234049). The AHA are available in diameters of Ø3.8 mm, 4.5mm, 5.5mm, and 6.5mm. They are available in 4 shapes designed according to specific areas of the dentition including S, S1, M, and XL, however, they are not limited to use exclusively in these positions. The AHA are offered in regular base (RB) and wide base (WB) configurations consistent with the Straumann BLX and BLC prosthetic platform offerings.

The AHAs may also be used in intraoral scanning procedures of single-unit restorations to represent the position, axis, and orientation of the dental implant placed in the patient's jaw relative to the surrounding dentition. A scanbody feature extends from the

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# Straumann Anatomic Healing Abutments XC (AHA)

K241575

occlusal surface of the AHA.

#### Intended Use

Straumann sterile healing components are intended for use with implants of the Straumann Dental Implant System (SDIS) to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process.

#### Indications for Use

Straumann Anatomic Healing Abutments are indicated to be placed in partially edentulous patients after implant placement. The healing components protect the inner configuration of the implant and form, maintain and stabilize the soft tissue during the healing process. Healing components have a maximum duration of usage of 180 days.

# Summary of Similarities and Differences in Technological Characteristics and Intended Use

The proposed indications for use for the subject AHA are the consistent with the indications for use for the currently marketed Straumann Healing Abutments. Both devices are intended as healing abutments for use with a Straumann dental implant to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. The duration of usage in both statements is identified as a maximum of 180 days stated in another format as up to six months (6 months times approximately 30 days per month results in 180 days). Table 1 includes the exact indications for use statements.

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# Straumann Anatomic Healing Abutments XC (AHA)

# K241575

Table 1 Comparison of the subject, primary predicate, and reference devices' indications for use

| | Subject Device<br>Straumann<br>Anatomic Healing<br>Abutments (AHA) | Primary Predicate<br>Straumann<br>Healing<br>Abutments<br>Institute<br>Straumann AG<br>K130808 | Reference Device<br>BellaTek Encode<br>Emergence Healing<br>Abutment<br>Biomet 3i LLC<br>K212730 | Reference Device<br>Straumann BLX<br>Basal Screws<br>Institute<br>Straumann AG<br>K173961 | Reference Device<br>Protective caps of<br>Straumann<br>Magellan Abutment<br>System<br>Institute Straumann<br>AG<br>K133421 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use Statement | Intended use<br>Straumann sterile<br>healing components<br>are intended for use<br>with implants of the<br>Straumann Dental<br>Implant System<br>(SDIS) to protect the<br>inner configuration of<br>the implant and<br>maintain, stabilize<br>and form the soft<br>tissue during the<br>healing process.<br>Indications for use<br>Straumann Anatomic<br>Healing Abutments<br>are indicated to be<br>placed in partially<br>edentulous patients<br>after implant | Closure screws,<br>healing caps, and<br>healing abutments,<br>are intended for use<br>with the Straumann<br>Dental Implant<br>System (SDIS) to<br>protect the inner<br>configuration of the<br>implant and<br>maintain, stabilize<br>and form the soft<br>tissue during the<br>healing process.<br>Customizable<br>healing abutments<br>made of PEEK are<br>for use up to six<br>months. | The BellaTek Encode<br>Emergence Healing<br>Abutments are<br>intended for use as<br>an accessory to<br>endosseous dental<br>implants during<br>endosseous and<br>gingival healing to<br>prepare gingival<br>tissue for acceptance<br>of a final abutment<br>and restoration.1 | Straumann BLX<br>Basal Screws and<br>Temporary<br>Abutments<br>Prosthetic<br>components<br>directly or indirectly<br>connected to the<br>endosseous dental<br>implant are<br>intended for use as<br>an aid in prosthetic<br>rehabilitations.<br>Temporary<br>components can be<br>used prior to the<br>insertion of the final<br>components to<br>maintain, stabilize<br>and shape the soft<br>tissue during the<br>healing phase; they | The Straumann<br>Magellan abutments<br>are indicated to be<br>placed into<br>Straumann dental<br>implants to provide<br>support for prosthetic<br>reconstructions such<br>as crowns, bridges<br>and bars.<br>The final processed<br>devices have the<br>purpose of restoring<br>chewing function.<br>Magellan abutments<br>are indicated for<br>screw-retained<br>restorations.<br>The protective caps<br>are placed on<br>abutments to protect |
| | | K241575 | | | |
| | Subject Device<br>Straumann<br>Anatomic Healing<br>Abutments (AHA) | Primary Predicate<br>Straumann<br>Healing<br>Abutments<br>Institute<br>Straumann AG<br>K130808 | Reference Device<br>BellaTek Encode<br>Emergence Healing<br>Abutment<br>Biomet 3i LLC<br>K212730 | Reference Device<br>Straumann BLX<br>Basal Screws<br>Institute<br>Straumann AG<br>K173961 | Reference Device<br>Protective caps of<br>Straumann<br>Magellan Abutment<br>System<br>Institute Straumann<br>AG<br>K133421 |
| | placement. The<br>healing components<br>protect the inner<br>configuration of the<br>implant and form,<br>maintain, and<br>stabilize the soft<br>tissue during the<br>healing process.<br>Healing components<br>have a maximum<br>duration of usage of<br>180 days. | | | may not be placed<br>into occlusion. Final<br>abutments may be<br>placed into<br>occlusion when the<br>implant is fully<br>osseointegrated.<br>BLX Temporary<br>Abutments have a<br>maximum duration<br>of usage of 180<br>days. | the outer<br>configuration of the<br>abutment and<br>maintain, stabilize<br>and contour the soft<br>tissue during the<br>healing process. |
| FDA Product<br>Code | NHA | NHA | NHA | NHA | NHA |

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# Straumann Anatomic Healing Abutments XC (AHA)

The technological characteristics of the subject AHA are consistent with those of the primary predicate and reference devices. Each device features a two-piece screw retained design. Like the previously cleared Straumann healing abutments customizable, the subject AHA may be customized and is composed of a PEEK abutment with a titaniumaluminum niobium (TAN) alloy basal screw that is supplied sterile by gamma radiation for single use. Like the previously

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# Straumann Anatomic Healing Abutments XC (AHA)

K241575

cleared Bellatek Encode Emergence Healing Abutments, the subject AHA can be scanned using an intra oral scanner and features markings that can be visualized in STL files. A detailed comparison of the subject, predicate, and reference devices is included in Table 2.

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### Straumann Anatomic Healing Abutments XC (AHA)

#### K241575

Table 2 Comparison of the design and technological characteristics of the subject, predicate, and reference devices

| | Subject Device<br>Straumann Anatomic<br>Healing Abutments<br>XC (AHA) | Primary Predicate<br>Straumann Healing<br>Abutments<br>Customizable<br>Institute Straumann<br>AG<br>K130808 | Reference<br>Device<br>BellaTek<br>Encode<br>Emergence<br>Healing<br>Abutment<br>K212730<br>Biomet 3i LLC | Reference Device<br>Straumann BLX Basal<br>Screws<br>Institute Straumann<br>AG<br>K173961 | Reference Device<br>Protective caps of Straumann<br>Magellan Abutment System<br>K133421 | Equivalence Discussion |
|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Abutment Design | Screw retained | Screw retained | Screw retained1 | Not applicable | Screw retained | Equivalent |
| Abutment Shape | Various anatomical<br>shapes intended for<br>different tooth<br>locations | Conical | Conical | Not applicable | Cylindrical protective caps | Numerous shapes of healing abutments are<br>available. The physician chooses the appropriately<br>sized healing abutment based on his treatment<br>plan. Many healing abutments can be further<br>modified chairside by the physician to fit the<br>patient's interocclusal space. No new questions of<br>safety or effectiveness are raised with anatomical<br>shaped healing abutments. |
| Body (Ø in mm) | 3.8, 4.5, 5.5, 6.5 | 5,7 | TSV abutments<br>3.5, 4.5, 5.7<br>Eztetic abutments<br>2.9<br>Certain<br>abutments 3.4,<br>4.1, 5.0 and 6.01 | Not applicable | 3.5, 4.6 | Body Ø is driven by the associated implant and<br>prosthetic system. Different implant systems have<br>different prosthetic platforms. No new questions of<br>safety or effectiveness are raised. |
| Abutment Length* | Ø3.8mm, Ø4.5mm:<br>6.2mm and 7.2mm<br>Ø5.5mm, Ø6.5mm:<br>6.4mm and 7.4mm | Ø5mm: 7.6mm<br>Ø7mm: 8mm | Not specified<br>(abutment height<br>3, 5, 7mm1) | Not applicable | Not applicable as placed on the<br>Magellan abutment. Lengths 5, 6,<br>8mm (from abutment) | Equivalent; the lengths of the proposed AHA are<br>within the range of those of the previously cleared<br>Straumann Healing Abutments customizable<br>(K130808). |
| Intraoral scanning<br>identification | Dots can be visualized<br>in STL files | No | Encode coding<br>scheme<br>(machined<br>markings) can be<br>visualized in STL<br>files1 | No | No | Equivalent; the AHA intraoral scanning<br>identification dots are equivalent to the encode<br>coding machined markings on the Bellatek Encode<br>Emergence healing abutments (K212730). |
| Body Material | Polyetheretherketone<br>(PEEK) Classix ASTM<br>F2026 | PEEK ASTM F2026 | Titanium-<br>aluminum-<br>vanadium alloy<br>(TAV) ASTM<br>F136 anodized1 | Not applicable | PEEK Classix<br>ASTM F2026 | Equivalent; The AHA is machined from the same<br>material PEEK Classix, as the protective caps of<br>the Straumann Magellan Abutment System<br>(K133421). The two devices fall in the same<br>contact category. |
| Screw Material | Titanium-aluminum-<br>niobium alloy (TAN) | TAN ISO 5832-11<br>anodized | TAV ASTM F1361 | TAN ISO 5832-11<br>anodized | TAN ISO 5832-11 | Same; the basal screw assembled with the AHA is<br>the same basal screw previously cleared in |
| Subject Device<br>Straumann Anatomic<br>Healing Abutments<br>XC (AHA) | Primary Predicate<br>Straumann Healing<br>Abutments<br>Customizable<br>Institute Straumann<br>AG<br>K130808 | Reference<br>Device<br>BellaTek<br>Encode<br>Emergence<br>Healing<br>Abutment<br>K212730<br>Biomet 3i LLC | Reference Device<br>Straumann BLX Basal<br>Screws<br>Institute Straumann<br>AG<br>K173961 | Reference Device<br>Protective caps of Straumann<br>Magellan Abutment System<br>K133421 | Equivalence Discussion | |
| Implant Interface | ISO 5832-11 anodized<br>Straumann TorcFit<br>(with conical fitting) | Straumann Regular<br>Crossfit (RC) and<br>Narrow Crossfit (NC)<br>(with conical fitting) | TSV abutments:<br>Zimmer Dental<br>TSV<br>Dental Implant<br>System<br>Eztetic<br>Abutments:<br>Zimmer Dental<br>Eztetic Dental<br>Implant System<br>Certain<br>Abutments:<br>Biomet 3i Certain<br>(Internal Hex)<br>Dental Implant<br>System¹ | Straumann TorcFit (with<br>conical fitting) | Interfaces with abutment | K173961.<br>Equivalent; each device is designed to mate with<br>an interface featured in a previously cleared<br>implant or abutment. More specifically, the AHA<br>mates with the Straumann TorcFit connection<br>which is present on the currently marketed<br>Straumann dental implants including the BLX<br>(K17396, K181703, K191256) and BLC (K230108<br>K234049). |
| Customization | Customizable | Customizable | Not specified | Not applicable | Customizable | Equivalent; the AHA is manufactured from PEEK<br>and customizable like the Straumann healing<br>abutments customizable (K130808) and the<br>protective caps of the Straumann Magellan<br>Abutment System (K133421). |
| Sterility/Sterilization | Sterile by gamma<br>radiation<br>End user steam<br>sterilized if customized | Sterile by gamma<br>radiation<br>End user steam<br>sterilized if<br>customized | Sterile by gamma<br>radiation¹ | Non-sterile, end user<br>steam sterilized | Non-sterile, end user steam<br>sterilized | Equivalent; The AHA is supplied sterile and<br>customizable like the previously cleared<br>Straumann healing abutments customizable<br>(K130808). |
| Packaging | Abutment assembled<br>with basal screw<br>Polyethylene<br>terephthalate glycol<br>(PETG) blister and lid<br>with a Tyvek lid | Abutment assembled<br>with basal screw<br>PETG blister and lid<br>with a Tyvek lid | Blister tray with<br>Tyvek Lid¹ | They are provided along<br>with the abutments but<br>they are also provided<br>as standalone screws.<br>Polyethylene<br>terephthalate glycol-<br>modified (PETGAG)<br>blister tray and an<br>Ovantex sealing lid | Four protective caps each<br>assembled with basal screw<br>PETGAG blister tray and an<br>Ovantex sealing lid | Equivalent; The AHA is packaged in the same<br>packaging as the previously cleared Straumann<br>healing abutments (K130808). |
| Usage | Single use, for up to | Single use, for up to 6 | Single use¹ | Single use | Single use, for use up to 6 | Equivalent |
| Subject Device<br>Straumann Anatomic<br>Healing Abutments<br>XC (AHA) | Primary Predicate<br>Straumann Healing<br>Abutments<br>Customizable<br>Institute Straumann<br>AG<br>K130808 | Reference<br>Device<br>BellaTek<br>Encode<br>Emergence<br>Healing<br>Abutment<br>K212730<br>Biomet 3i LLC | Reference Device<br>Straumann BLX Basal<br>Screws<br>Institute Straumann<br>AG<br>K173961 | Reference Device<br>Protective caps of Straumann<br>Magellan Abutment System<br>K133421 | Equivalence Discussion | |
| 180 days | months | | | months | | |

1 BellaTek Encode Emergence Healing Abutments 510(k) Summary K212730 accessed at: K212730.pdf ffda.gov).

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### Straumann Anatomic Healing Abutments XC (AHA)

K241575

Institut Straumann AG

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### Straumann Anatomic Healing Abutments XC (AHA)

K241575

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### Straumann Anatomic Healing Abutments XC (AHA)

K241575

# Performance Testing Sterilization Validation and Shelf Life

The subject devices will be gamma irradiated. like the predicate devices in K130808. The AHA have been assessed for their relative challenge to the sterilization process by comparison to similar devices previously validated to a sterility assurance level (SAL) of 10-9, utilizing VDmax25 in accordance with ISO 11137-1:2006. The standard dose of radiation used for routine irradiation sterilization is 25 kilogray. This dose has been validated in accordance with ISO 11137-1: 2006, utilizing VDmax25 in accordance with ISO 11137-2: 2013, to achieve a sterility assurance level of 10-6.

If the AHA is customized, the device must be steam sterilized prior to intra-oral use. A validation of the labeled steam sterilization cycle using the half cycle validation approach outlined in ANSI/AAMI/ISO 17665-1: 2006/(R)2013, Annex D was performed with a subject device. All test method acceptance criteria were met.

The subject AHAs are labeled with a 5-year shelf-life like the previously cleared Straumann healing abutments (K130808). The packaging materials, configuration, and sterilization method for the AHA are the same as the Straumann healing abutments. Also, the subject AHA do not represent a new worst case in terms of dimension and weight, therefore, the packaging stability study for the Straumann healing abutments is adopted to support the subject AHA.

The subject devices are implants and will not be marketed as non-pyrogenic. The method used to make the determination that the devices meet pyrogen limit specifications is the Limulus amebocyte lysate (LAL) test. The testing limit is 20 endotoxin units (EU)/device. The testing limit is consistent with the recommendation identified in the FDA Guidance Submission and review of sterility information in premarket notification (510(k)) submissions for devices labeled as sterile.

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### Straumann Anatomic Healing Abutments XC (AHA)

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### Biocompatibility Testing

Biological assessment has been performed according to ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process and to the FDA Guidance document Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, (June 16, 2016). The subject AHA devices are manufactured from PEEK Classix conforming to ASTM F2026. The AHA share the same nature of body contact, contact duration, device material and manufacturing process as the reference protective caps of the Straumann Magellan Abutment System (K133421). Unlike the reference protective caps, the subject AHAs will be sterile packaged, and gamma irradiated. Cytotoxicity and chemical extraction tests were performed. No cytotoxic reaction was detected. No extractable substances were detected in the chemical analysis above the analytical evaluation threshold (AET). The basal screws of the subject AHA are manufactured from Titanium-aluminumniobium alloy (TAN) conforming to ISO 5832-11. The basal screws of the subject AHA share the same nature of body contact, contact duration, material formulation, and sterilization methods as the basal screws of the primary predicate Straumann healing

abutments customizable (K130808) and therefore, no new testing has been performed on these devices.

### Electromagnetic Compatibility

No new materials or worst-case constructs were introduced compared to the Straumann portfolio MR tested in accordance with FDA's quidance testing and labeling medical devices for safety in the magnetic resonance (MR) environment and cleared under K190662.

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# Straumann Anatomic Healing Abutments XC (AHA)

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#### Performance Testing - Bench

The physician will insert the AHA during the implant placement surgery or in the reopening surgery (second surgical phase) and remove the AHA upon placement of a final abutment and restoration. Therefore, torque testing was performed to demonstrate the AHA withstands repeated insertion and removal torques without damage.

### Software Testing

A scan verification test and software integration were performed to demonstrate the subject AHAs can be scanned with an intraoral scanner and are suitable to work with CARES Visual software.

### Conclusion

The documentation submitted in this premarket notification demonstrates the subject devices are substantially equivalent to the primary predicate and reference devices.