(206 days)
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No
The document describes a physical dental implant abutment made of PEEK material. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies focus on material properties, sterilization, and packaging.
Yes
The device is a premanufactured prosthetic component intended for provisional use as an aid in prosthetic rehabilitation, clearly indicating a role in treating or managing a condition related to dental health.
No
The device description indicates that the Southern Implants PEEK Abutments are "premanufactured prosthetic components directly connected to endosseous dental implants and are intended for provisional use...as an aid in prosthetic rehabilitation." They are used to maintain tissue openings or aid in manufacturing temporary prosthetics. There is no mention of the device being used to identify or analyze a disease or medical condition.
No
The device description clearly states that the device is a physical component made from PEEK material, intended for direct connection to dental implants. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Southern Implants PEEK Abutments are physical components used in dental surgery to connect a prosthesis to a dental implant. They are used in vivo (within the body) and are not involved in testing biological samples.
- Intended Use: The intended use is for "provisional use up to 180 days as an aid in prosthetic rehabilitation," which is a surgical and prosthetic function, not a diagnostic one.
- Device Description: The description details the physical characteristics, materials, and types of abutments, all related to their mechanical function in dental restoration.
- Performance Studies: The performance studies focus on sterilization, packaging, biocompatibility, and cytotoxicity, which are relevant to the safety and efficacy of an implantable device, not a diagnostic test.
Therefore, the Southern Implants PEEK Abutments fall under the category of a medical device used in surgery and prosthetics, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
NHA
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Endosseous dental implants
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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 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.
No clinical studies were conducted.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 872.3630 Endosseous dental implant abutment.
(a)
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.(b)
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.)
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
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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)
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510(k) Summary
Sponsor:
| Company Name: | Southern Implants (Pty) Ltd. |
|---|---|
| Company Address: | 1 Albert Road |
| 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 | |||
| Predicate | Nobel Biocare AB | NobelProcera PEEK Abutments | K120954 |
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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 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
(K120954) |
|-------------------------|----------------------------------------------------------------------------------------------------------------------|--------------------------------|
| | Southern Implants PEEK abutments | NobelProcera PEEK Abutments |
| Product Code | PK-MAX7-9; PK-MAX7-11;
PK-MAX8-11; PK-L-MAX7-9;
PK-L-MAX7-11; PK-L-MAX8-9;
PK-L-MAX8-11; PKA-Z6-9; PKAZ8-11 | 37819; 37820 |
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| 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. | The Nobel Biocare 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. |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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
Connection | Southern Implants MAX
● External Hex
● Tri-Nex
● Internal Hex | Nobel Biocare
● Internal Conical |
| Height (mm) | 5 – 6 mm | 5 mm |
| Diameter (mm) | 6 × 9
8 × 11 | 6 x 7
7 × 8 |
| Abutment Profile | Various anatomical shapes intended
for different tooth locations | Various anatomical shapes intended
for different tooth locations or
individually designed with Procera
system |
| Sterility | Sterile | Sterile |
| Device and Manufacturer | New device | Primary Predicate
(K120954) |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | Southern Implants PEEK abutments
PKPN2H; PKBN2NH;
PKB2H; PKB2NH; PKBA2H; PKBA2NH;
PKBBB2H; PKBBB2NH;
PKMAX9-2H; PKMAX9-2NH;
PKC-EL-35-2; PKC-NL-35-2;
PKC-EL-43-2; PKC-NL-43-2;
PKC-EL-50-2; PKC-NL-50-2;
PKC-EL-60-2; PKC-NL-60-2;
PKC-DC3-2; PKC-NDC3-2;
PKC-DC4-2; PKC-NDC4-2;
PKC-DC5-2; PKC-NDC5-2;
ITS6-PKC1; ITS-PKC1;
PKC-MC; PKC-MCW. | NobelProcera PEEK Abutments
30259, 30260, 30261, 30262, 30256,
30257, 30258, 31350, 31351, 31352,
31353, 1048-0, 1050-0, 1052-0. |
| 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. | The Nobel Biocare 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. |
| Intended Use | Temporary Abutment | Provisional Abutment |
| Material | Polyetheretherketone (PEEK) | Polyetheretherketone (PEEK) |
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| 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 | ||
| 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.