(210 days)
Not Found
No
The document describes a physical dental implant abutment made of PEEK material. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is a premanufactured prosthetic component intended for provisional use as an aid in prosthetic rehabilitation, not for treating a disease or condition itself.
No
The device is a premanufactured prosthetic component (abutment) used to aid in prosthetic rehabilitation, not for diagnosing a condition.
No
The device description clearly states it is a physical component (abutment) made of PEEK material, intended for direct connection to dental implants. It also mentions titanium retaining screws. This indicates a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Southern Implants PEEK Abutments are physical components that are directly connected to dental implants within the patient's mouth. They are used for prosthetic rehabilitation.
- Intended Use: The intended use is for provisional use as an aid in prosthetic rehabilitation, which is a clinical procedure performed on the patient.
The device is a medical device used in vivo (within the body), not an in vitro diagnostic device used to test samples outside the body.
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 (comma separated list FDA assigned to the subject device)
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.)
0
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.
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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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3
510(k) Summary
Sponsor:
| Company Name: | Southern Implants (Pty) Ltd |
|---|---|
| Company Address: | 1 Albert Road |
| Irene, | |
| 0062 | |
| 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
(K172160) |
|-------------------------|-----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Southern Implants PEEK abutments | Southern Implants PEEK abutments |
| Product Code | PKIP2H; PKIP2NH; PKC-M-2;
PKC-NM-2 | PKBN2H; 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. |
| Indications for Use | The Southern Implants PEEK
Abutments are premanufactured
prosthetic components directly | The Southern Implants PEEK
Abutments are premanufactured
prosthetic components directly |
5
| | connected to endosseous dental
implants and are intended for
provisional use up to 180 days as an
aid in prosthetic rehabilitation. | 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 | Temporary Abutment |
| Material | Polyetheretherketone (PEEK) | Polyetheretherketone (PEEK) |
| Colour | White | White |
| Attachment Method | Screw retained
Engaging and Non-Engaging | Screw retained
Engaging and Non-Engaging |
| Duration of use | 180 days, single use | 180 days, single use |
| Implant/Abutment
Connection | External Hex
Internal Hex | Southern Implants MAX
External Hex
Tri-Nex
Deep Conical
Internal Hex
Internal Taper
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.
6
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.