Southern Implants PEEK Abutments

K191250 · Southern Implants (Pty), Ltd. · NHA · Dec 5, 2019 · Dental

Device Facts

• Record ID: K191250
• Device Name: Southern Implants PEEK Abutments
• Applicant: Southern Implants (Pty), Ltd.
• Product Code: NHA · Dental
• Decision Date: Dec 5, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Southern Implants PEEK Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.

Device Story

Premanufactured prosthetic components; connect directly to endosseous dental implants. Used as aid in manufacturing temporary prostheses for prosthetic rehabilitation. Available in various preformed/customized forms; engaging and non-engaging connections; 2 mm collar height. Fabricated from white PEEK; used with titanium retaining screws. Operated by dental professionals in clinical settings. Provides temporary support for prosthetic structures; facilitates patient rehabilitation during healing period. Delivered sterile; supports user steam sterilization.

Clinical Evidence

No clinical studies were conducted. Substantial equivalence is supported by non-clinical bench testing, including biocompatibility (ISO 10993-1, ISO 10993-5), sterilization validation (ISO 11137, ISO 17665), and packaging validation (ISO 11607, ASTM F1980).

Technological Characteristics

Material: Polyetheretherketone (PEEK) per ASTM F2026. Form factor: Cylinder with retention features, various diameters (3.35-4.00 mm) and heights. Connection: Engaging/non-engaging, screw-retained. Sterilization: Gamma radiation (primary), steam sterilization (user).

Indications for Use

Indicated for patients requiring provisional prosthetic rehabilitation via endosseous dental implants for a duration of up to 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

• Southern Implants PEEK abutments (K172160)

Submission Summary (Full Text)

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December 5, 2019

Southern Implants (Pty) Ltd Lauranda Breytenbach Regulatory Affairs and Quality 1 Albert Road Irene, Gauteng 0062 SOUTH AFRICA

Re: K191250

Trade/Device Name: Southern Implants PEEK Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: September 6, 2019 Received: September 10, 2019

Dear Lauranda Breytenbach:

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. 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 located 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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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) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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.

for Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K191250

#### Device Name Southern Implants PEEK Abutments

Indications for Use (Describe)

The Southern Implants PEEK Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary

#### Sponsor:

| Company Name: | Southern Implants (Pty) Ltd |
|------------------|-------------------------------------------------|
| Company Address: | 1 Albert Road<br>Irene,<br>0062<br>South Africa |
| Telephone: | + 27 12 667 1046 |
| Fax: | + 27 72 313 5715 |
| Contact Person: | Lauranda G. Breytenbach |

Summary Preparation Date: May 7, 2018

Device Name:

| Trade Name: | Southern Implants PEEK Abutments |
|----------------------|---------------------------------------|
| Common/Usual Name: | PEEK Abutments |
| Classification Name: | Abutment, Implant, Dental, Endosseous |
| Regulation Number: | 21 CFR 872.3630 |
| Product Codes: | NHA |
| Device Class: | Class II |
| Predicate Devices: | |

Manufacturer Predicate # Device Name K Number Primary Southern Implants Southern Implants PEEK abutments K172160 Predicate (Pty) Ltd

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### Device Description:

The Southern Implants PEEK abutments are endosseous dental implant abutments. The PEEK abutments are available in a variety of preformed and customized forms. The PEEK abutments are available as temporary abutments.

Temporary abutments are used as an aid in manufacturing a temporary prosthesis for prosthetic rehabilitation. They are used for direct connection to an endosseous implant. Temporary abutments are available in a 2 mm collar direct to implant.

These abutments are made from white PEEK (ASTM F2026).

The PEEK abutments are premanufactured and are available in a variety of connections, engaging and nonengaging, to suit the implant systems manufactured by Southern Implants.

Titanium retaining screws are also available to use with the PEEK abutments.

## Indications for Use

The Southern Implants PEEK Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.

## Equivalence to Predicates

Southern Implants (Pty) Ltd submits the information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the substantially equivalent in indications and design principles to the following legally marketed predicate devices:

#### K172160, Southern Implants PEEK Abutments

Tables comparing the subject device and primary predicate devices is provided below.

| Device and Manufacturer | New device | Primary Predicate<br>(K172160) |
|-------------------------|-----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <i>Southern Implants PEEK abutments</i> | <i>Southern Implants PEEK abutments</i> |
| Product Code | PKIP2H; PKIP2NH; PKC-M-2;<br>PKC-NM-2 | PKBN2H; PKBN2NH;<br>PKB2H; PKB2NH; PKBA2H;<br>PKBA2NH; PKBBB2H;<br>PKBBB2NH;<br>PKMAX9-2H; PKMAX9-2NH;<br>PKC-EL-35-2; PKC-NL-35-2;<br>PKC-EL-43-2; PKC-NL-43-2;<br>PKC-EL-50-2; PKC-NL-50-2;<br>PKC-EL-60-2; PKC-NL-60-2;<br>PKC-DC3-2; PKC-NDC3-2;<br>PKC-DC4-2; PKC-NDC4-2;<br>PKC-DC5-2; PKC-NDC5-2;<br>ITS6-PKC1; ITS-PKC1;<br>PKC-MC; PKC-MCW. |
| Indications for Use | The Southern Implants PEEK<br>Abutments are premanufactured<br>prosthetic components directly | The Southern Implants PEEK<br>Abutments are premanufactured<br>prosthetic components directly |

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| | connected to endosseous dental<br>implants and are intended for<br>provisional use up to 180 days as an<br>aid in prosthetic rehabilitation. | connected to endosseous dental<br>implants and are intended for<br>provisional use up to 180 days as an<br>aid in prosthetic rehabilitation. |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Temporary Abutment | Temporary Abutment |
| Material | Polyetheretherketone (PEEK) | Polyetheretherketone (PEEK) |
| Colour | White | White |
| Attachment Method | Screw retained<br>Engaging and Non-Engaging | Screw retained<br>Engaging and Non-Engaging |
| Duration of use | 180 days, single use | 180 days, single use |
| Implant/Abutment<br>Connection | External Hex<br>Internal Hex | Southern Implants MAX<br>External Hex<br>Tri-Nex<br>Deep Conical<br>Internal Hex<br>Internal Taper<br>Compact Conical |
| Height (mm) | 14.5 | 9-14.5 |
| Collar height (mm) | 2 | 1-2 |
| Diameter (mm) | 3.35 - 4.00 | 3.35 - 7.35 |
| Abutment Profile | Cylinder with retention feature | Cylinder with retention feature |
| Sterility | Sterile | Sterile |

The Southern Implants PEEK abutments are substantially equivalent to predicate device in:

- Indications for Use ●
- . Intended Use
- Material
- Colour
- Attachment Method
- . Duration of Use
- . Implant/Abutment Connection
- Height
- Collar height ●
- . Diameter
- Abutment Profile
- . Sterility

The Southern Implants PEEK Abutments are delivered to the patients sterile and can be user sterilized if required.

#### Nonclinical Testing and Performance Testing

Non-clinical testing data provided or referenced to demonstrate substantial equivalence included:

The sterilization method is Gamma radiation and has been validated in accordance with ISO 11137.

The proposed user sterilization method is steam sterilization and is validated in accordance with ISO 17665.

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Packaging was validated in accordance with ISO 11607. Accelerated aging per ASTM-F-1980 has been applied on the final packaging followed by validating durability to peel and dye tests conditions, in order to substantiate 5 years shelf life.

The subject device is manufactured from the same material using the same manufacturing method as the predicate, has the same intended use, and the same patient contact type and duration. The subject devices are biocompatible in accordance with ISO 10993-1.

The subject device shown no cytotoxicity when tested in accordance with ISO 10993-5.

## Clinical Studies

No clinical studies were conducted.

## Final Conclusion

Substantial equivalence has been shown for Southern Implants PEEK Abutments.