Southern Implants PEEK Abutments

K172160 · Southern Implants (Pty), Ltd. · NHA · Feb 9, 2018 · Dental

Device Facts

• Record ID: K172160
• Device Name: Southern Implants PEEK Abutments
• Applicant: Southern Implants (Pty), Ltd.
• Product Code: NHA · Dental
• Decision Date: Feb 9, 2018
• 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

Southern Implants PEEK Abutments are premanufactured prosthetic components for endosseous dental implants; used as healing or temporary abutments. Healing abutments maintain tissue openings during prosthesis fabrication; temporary abutments aid in manufacturing temporary prosthetic rehabilitations. Devices are screw-retained; available in various engaging/non-engaging connections to suit Southern Implants systems. Used by dental clinicians in clinical settings. Output is a physical interface for prosthetic attachment; facilitates tissue healing and temporary restoration. Benefits include provisional support during rehabilitation period. Manufactured from white PEEK; supplied sterile.

Clinical Evidence

No clinical studies were conducted. Evidence is based on bench testing, including biocompatibility (ISO 10993-1, ISO 10993-5), sterilization validation (ISO 11137, ISO 17665), packaging validation (ISO 11607), and shelf-life testing (ASTM F1980).

Technological Characteristics

Material: Polyetheretherketone (PEEK) per ASTM F2026. Components: Healing and temporary abutments with titanium retaining screws. Connection: Various engaging/non-engaging types for Southern Implants systems. Sterilization: Gamma radiation (device) and steam sterilization (user).

Indications for Use

Indicated for patients requiring provisional prosthetic rehabilitation via endosseous dental implants for 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

• NobelProcera PEEK Abutments (K120954)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized eagle. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" underneath.

Southern Implants (Pty) Ltd % Kevin Walls Consultant Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton, Colorado 80127

February 9, 2018

Re: K172160

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: January 5, 2018 Received: January 8, 2018

Dear Kevin Walls:

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); medical device 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);

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

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}------------------------------------------------

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

### K172160

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 implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation.

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)

#### 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."

PSC Publishing Services [phone] EF

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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

# 510(k) Summary

## Sponsor:

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

| Summary Preparation Date: | February 8, 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:

| Predicate # | Manufacturer | Device Name | K Number |
|----------------------|------------------|-----------------------------|----------|
| Primary<br>Predicate | Nobel Biocare AB | NobelProcera PEEK Abutments | K120954 |

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

### 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 healing abutments or temporary abutments.

The healing abutments are attached onto the implant during phase 2 surgery to maintain the tissue opening while the prosthesis is being fabricated. Temporary abutments are used as an aid in manufacturing a temporary prosthetic rehabilitation. They can either be used for direct connection to an endosseous implant or they can be used for connecting the prosthesis to a compact conical abutments. Temporary abutments are available in a 2 mm collar direct to implant and 1mm collar on abutment level. The temporary abutments for the compact conical abutments are for multi-unit use only.

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

The PEEK abutments are premanufactured and are available in a variety of connections, engaging and non-engaging, 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 subject device is substantially equivalent in indications and design principles to the following legally marketed predicate devices:

K120954, Nobel Procera PEEK Abutments

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

| Device and Manufacturer | New device | Primary Predicate<br>(K120954) |
|-------------------------|----------------------------------------------------------------------------------------------------------------------|--------------------------------|
| | Southern Implants PEEK abutments | NobelProcera PEEK Abutments |
| Product Code | PK-MAX7-9; PK-MAX7-11;<br>PK-MAX8-11; PK-L-MAX7-9;<br>PK-L-MAX7-11; PK-L-MAX8-9;<br>PK-L-MAX8-11; PKA-Z6-9; PKAZ8-11 | 37819; 37820 |

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

| Indications for Use | The Southern Implants PEEK<br>Abutments are premanufactured<br>prosthetic components directly<br>connected to endosseous dental<br>implants and are intended for<br>provisional use up to 180 days as an<br>aid in prosthetic rehabilitation. | The Nobel Biocare PEEK Abutments<br>are premanufactured prosthetic<br>components directly connected to<br>endosseous dental implants and are<br>intended for provisional use up to<br>180 days as an aid in prosthetic<br>rehabilitation. |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Healing Abutment | Healing Abutment |
| Material | Polyetheretherketone (PEEK) | Polyetheretherketone (PEEK) |
| Colour | White | Natural and White |
| Attachment Method | Screw retained | Screw retained |
| Duration of use | 180 days, single use | 180 days, single use |
| Implant/Abutment<br>Connection | Southern Implants MAX<br>● External Hex<br>● Tri-Nex<br>● Internal Hex | Nobel Biocare<br>● Internal Conical |
| Height (mm) | 5 – 6 mm | 5 mm |
| Diameter (mm) | 6 × 9<br>8 × 11 | 6 x 7<br>7 × 8 |
| Abutment Profile | Various anatomical shapes intended<br>for different tooth locations | Various anatomical shapes intended<br>for different tooth locations or<br>individually designed with Procera<br>system |
| Sterility | Sterile | Sterile |

| Device and Manufacturer | New device | Primary Predicate<br>(K120954) |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | Southern Implants PEEK abutments<br>PKPN2H; PKBN2NH;<br>PKB2H; PKB2NH; PKBA2H; PKBA2NH;<br>PKBBB2H; 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. | NobelProcera PEEK Abutments<br>30259, 30260, 30261, 30262, 30256,<br>30257, 30258, 31350, 31351, 31352,<br>31353, 1048-0, 1050-0, 1052-0. |
| Indications for Use | The Southern Implants PEEK<br>Abutments are premanufactured<br>prosthetic components directly<br>connected to endosseous dental<br>implants and are intended for<br>provisional use up to 180 days as an<br>aid in prosthetic rehabilitation. | The Nobel Biocare PEEK Abutments<br>are premanufactured prosthetic<br>components directly connected to<br>endosseous dental implants and are<br>intended for provisional use up to<br>180 days as an aid in prosthetic<br>rehabilitation. |
| Intended Use | Temporary Abutment | Provisional Abutment |
| Material | Polyetheretherketone (PEEK) | Polyetheretherketone (PEEK) |

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

| Colour | White | Natural and White |
|--------------------------------|---------------------------------|---------------------------------|
| Attachment Method | Screw retained | Screw retained |
| | Engaging and Non-Engaging | Engaging and Non-Engaging |
| Duration of use | 180 days, single use | 180 days, single use |
| Implant/Abutment<br>Connection | Southern Implants MAX | Nobel Biocare |
| | • External Hex | • External Hex |
| | • Tri-Nex | • Internal Tri-lobe |
| | • Deep Conical | |
| | • Internal Hex | |
| | • Internal Taper | |
| | • Compact Conical | |
| Height (mm) | 9-14.5 | 12 |
| Collar height | 1-2 | 1-1.5 |
| Diameter (mm) | 3.35 - 7.35 | Not given |
| Abutment Profile | Cylinder with retention feature | Cylinder with retention feature |
| Sterility | Sterile | Non-Sterile |

The Southern Implants PEEK Healing Abutments minimum diameter and height is the same as the Primary Predicate. The Southern Implants range has a slightly higher version and wider version because it is used on wider implant platforms (up to Ø7 compared to the Ø5.5 platform of the predicate).

The Southern Implants PEEK Temporary Abutments have a range of lengths that falls on either side of the Primary Predicate temporary abutment lengths, by up to 3 mm. The difference in length is immaterial since all lengths fall within the range of lengths that a prosthetic can be made to. If the PEEK abutment is shorter it will just need to be built up more, and if it is longer it will just need to be cut down more.

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

- Indications for Use
- Intended Use
- Material
- Colour
- Attachment Method
- Duration of Use
- Abutment Profile

The Southern Implants PEEK Abutments are delivered to the patients sterile and is not intended for user sterilization as the predicate. The Southern Implants PEEK Abutments are also available in more connection systems as the predicate to compliment the Southern Implants' range.

## 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.
- Packaging was validated in accordance with ISO 11607. Accelerated aging per ASTM-F-1980

{7}------------------------------------------------

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.