(226 days)
No
The summary describes dental implants and abutments, focusing on materials, dimensions, and mechanical testing. There is no mention of AI or ML.
No
The device is a dental implant system used to provide support for fixed dental prostheses, which is a restorative function rather than a therapeutic one designed to treat a disease or condition.
No
The device description indicates that the implants are intended to be "implanted in the upper jaw arch to provide support for fixed dental prostheses." This describes a therapeutic, rather than a diagnostic, function.
No
The device description clearly details physical dental implants and abutments made of titanium, which are hardware components. There is no mention of software as the primary or sole component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "implanted in the upper jaw arch to provide support for fixed dental prostheses in partially or fully edentulous maxillae." This describes a surgical implant for structural support within the body.
- Device Description: The description details physical components like implants and abutments made of titanium, designed for placement into bone. This is consistent with a medical device, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Southern Implants ZAGA Zygomatic System implants are intended to be implanted in the upper jaw arch to provide support for fixed dental prostheses in patially or fully edentulous maxillae. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
This submission includes partially threaded root-form dental implants and mating abutments designed for placement into the zygomatic bone. All implants are provided with an external hexagon abutment interface angled 55° at the head of the implants are provided in two designs: the ZAGA Regular zygomatic implant, coronally and apically threaded, diameter 4.3 mm (coronal) tapering to 3.4 mm (apical), in overall lengths ranging of 35 mm and 55 mm; and the ZAGA Advanced zygomatic implant, apically threaded, diameter 4.3 mm (coronal) tapering to 3.4 mm (apical), in overall lengths ranging from 30 mm to 52.5 mm, with a flat cut into the buccalfacing side of the implant body.
This submission includes designs of the ZAGA screw-retained abutments in four gingival heights (1.5, 2.5, 3.5, and 4.5 mm) for use with the ZAGA zygomatic implants. The subject device abutments are for support of screwretained overdenture prosthetic restorations.
All subject device implants are manufactured from unalloyed titanium conforming to ASTM F67. The apically threaded portions of the implants have the identical aluminum oxide grit-blasted surface as the implants cleared in K173343. The subject device ZAGA screw-retained abutments are manufactured titanium conforming to ASTM F67, and have the same anodized surface treatment as the healing abutments cleared in K163634. All of the subject device components are manufactured in the same facilities using the same manufacturing processes as used for the Southern Implants previously cleared in K173343 and K163634.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper jaw arch, zygomatic bone
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 data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility (referenced from K173343 and K163634); engineering analysis; dimensional analysis; sterilization validation according to ISO 11137-1, ISO 11137-2; bacterial endotoxin according to USP 39-NF34; sterile barrier shelf life (referenced from K173343); and static an dynamic compression-bending according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants. No clinical data were included in this submission.
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.
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
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
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May 7, 2020
Southern Implants (Pty) Ltd Lauranda Breytenbach Head of Regulatory Affairs and Ouality 1 Albert Road Irene, Gauteng 0062 SOUTH AFRICA
Re: K192651
Trade/Device Name: ZAGA Zygomatic System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: March 23, 2020 Received: April 7, 2020
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
2
Indications for Use
510(k) Number (if known) K192651
Device Name ZAGA Zygomatic System
Indications for Use (Describe)
Southern Implants ZAGA Zygomatic System implants are intended to be implanted in the upper jaw arch to provide support for fixed dental prostheses in patially or fully edentulous maxillae. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
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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3
510(k) Summary
ZAGA Zygomatic System
K192651
May 6, 2020
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Southern Implants (Pty) Ltd | |
|---|---|---|
| 1 Albert Road | ||
| Irene, Gauteng, 0062 South Africa | ||
| Telephone: | +27 12 667 1046 | |
| Fax: | +27 12 667 1029 | |
| Official Contact | Lauranda G. Breytenbach | |
| Head of Regulatory Affairs and Quality | ||
| Email: lauranda.b@southernimplants.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | ZAGA Zygomatic System |
|---|---|
| Common Name | Dental implant |
| Classification Name | Endosseous dental implant |
| Classification Regulation | 21 CFR 872.3640, Class II |
| Product Code | DZE, NHA |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |
PREDICATE DEVICE INFORMATION
The primary predicate device is K173343. The reference devices are K163634 and K181703.
4
INDICATIONS FOR USE STATEMENT
Southern Implants ZAGA Zygomatic System implants are intended to the upper jaw arch to provide support for fixed dental prostheses in patially or fully edentulous maxillae. All implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
SUBJECT DEVICE DESCRIPTION
This submission includes partially threaded root-form dental implants and mating abutments designed for placement into the zygomatic bone. All implants are provided with an external hexagon abutment interface angled 55° at the head of the implants are provided in two designs: the ZAGA Regular zygomatic implant, coronally and apically threaded, diameter 4.3 mm (coronal) tapering to 3.4 mm (apical), in overall lengths ranging of 35 mm and 55 mm; and the ZAGA Advanced zygomatic implant, apically threaded, diameter 4.3 mm (coronal) tapering to 3.4 mm (apical), in overall lengths ranging from 30 mm to 52.5 mm, with a flat cut into the buccalfacing side of the implant body.
This submission includes designs of the ZAGA screw-retained abutments in four gingival heights (1.5, 2.5, 3.5, and 4.5 mm) for use with the ZAGA zygomatic implants. The subject device abutments are for support of screwretained overdenture prosthetic restorations.
All subject device implants are manufactured from unalloyed titanium conforming to ASTM F67. The apically threaded portions of the implants have the identical aluminum oxide grit-blasted surface as the implants cleared in K173343. The subject device ZAGA screw-retained abutments are manufactured titanium conforming to ASTM F67, and have the same anodized surface treatment as the healing abutments cleared in K163634. All of the subject device components are manufactured in the same facilities using the same manufacturing processes as used for the Southern Implants previously cleared in K173343 and K163634.
PERFORMANCE DATA
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility (referenced from K173343 and K163634); engineering analysis; dimensional analysis; sterilization validation according to ISO 11137-1, ISO 11137-2; bacterial endotoxin according to USP 39-NF34; sterile barrier shelf life (referenced from K173343); and static an dynamic compression-bending according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants. No clinical data were included in this submission.
EQUIVALENCE TO MARKETED DEVICE
Southern Implants (Pty) Ltd submits the information in this Premarket Notification to demonstrate that, for the purposes of FDA 's regulation of medical device is substantially equivalent in indications and design principles to the following legally marketed predicate devices:
K173343, Zygomatic Implant System, Southern Implants (Pty) Ltd. K163634, External Hex Implants, Southern Implants (Pty) Ltd. K181703, Straumann® BLX Line Extension - Implants, SRAs and Anatomic Abutments, Straumann USA, LLC (on behalf of Institut Straumann AG)
The primary predicate device is K173343. The reference devices are K163634 and K181703.
A comparison of the technological characteristics of the subject device and the primary predicate device K17343 is provided in the following table.
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| Subject Device | Primary Predicate Device | |
|---|---|---|
| K173343 | ||
| Comparison | ZAGA Zygomatic System | Zygomatic Implant System |
| Southern Implants (Pty) Ltd | Southern Implants (Pty) Ltd | |
| Indications for Use Statement | Southern Implants ZAGA Zygomatic System | |
| implants are intended to be implanted in the | ||
| upper jaw arch to provide support for fixed | ||
| dental prostheses in patients with partially or | ||
| fully edentulous maxillae. All implants are | ||
| appropriate for immediate loading when good | ||
| primary stability is achieved and with | ||
| appropriate occlusal loading. | Southern Implants Zygomatic System Standard | |
| implants, Zygan (narrow apex) implants, and | ||
| Oncology implants are intended to be implanted | ||
| in the upper jaw arch to provide support for | ||
| fixed or removable dental prostheses in patients | ||
| with partially or fully edentulous maxillae. All | ||
| implants are appropriate for immediate loading | ||
| when good primary stability is achieved and | ||
| with appropriate occlusal loading. | ||
| Implant | ||
| Implant Design | Partially threaded root-form implants for | |
| placement into the zygoma. | Zygan and Oncology: Partially threaded root- | |
| form implants for placement into the zygoma. | ||
| Implant Diameter | ZAGA Regular: 4.3 mm (coronal) taper to 3.4 | |
| mm (apical) | ||
| ZAGA Advanced: 4.3 mm (coronal with 3.35 | ||
| mm flat) taper to 3.4 mm (apical) | Zygan: 4.3 mm (coronal) taper to 3.4 mm | |
| (apical) | ||
| Oncology: 4.3 mm (coronal) taper to 3.8 mm | ||
| (apical) | ||
| Implant Length | ZAGA Regular: 35, 37.5, 40, 42.5, 45, 47.5, 50, | |
| 52.5, 55 mm | ||
| ZAGA Advanced: 30, 32.5, 35, 37.5, 40, 42.5, | ||
| 45, 47.5, 50, 52.5 mm | Zygan: 30, 35, 37.5, 40, 42.5, 45, 47.5, 50, | |
| 52.5, 55, 57.5 mm | ||
| Oncology: 27.5, 30, 32.5, 37.5, 42.5, 47.5 mm | ||
| Threaded Lengths | ZAGA Regular: 5 mm coronal + 17 mm apical | |
| ZAGA Advanced: 17 mm (apical only) | Standard implant: Fully threaded | |
| Zygan implant: 6 mm coronal + 15 mm apical | ||
| Oncology implant: 20 mm (apical only) | ||
| Platform Angle, Relative to | ||
| orthogonal to implant long axis | 55° angulation at head of implant | 55° angulation at head of implant |
| Implant Prosthetic Diameter | 4.07 mm | 4.05 mm |
| Implant Interface | External Hex | External Hex |
| Implant Material | Unalloyed titanium (ASTM F67) Grade 4, and | |
| UTS ≥ 900MPa (cold-worked) | Unalloyed titanium (ASTM F67) Grade 4, and | |
| UTS ≥ 900MPa (cold-worked) | ||
| Implant Endosseous Surface | Grit-blasted | Grit-blasted |
| Abutment | ||
| Abutment Design | Non-engaging; Compact conical design | Non-engaging; Compact conical design |
| Prosthetic Attachment | Screw-retained | Screw-retained |
| Collar Height | 1.5, 2.5, 3.5, 4.5 mm | 1.5, 2.0, 3.0, 4.0, 5.5 mm |
| Collar Diameter | 4.6 mm | 4.8 mm |
| Abutment Angle | None (straight only) | None (straight only) |
| Abutment Material | Unalloyed titanium (ASTM F67) Grade 4; with | |
| anodized surface treatment | Titanium alloy (ASTM F136) Grade 5; | |
| Titanium Nitride (TiN) coating | ||
| Restoration | Multi-unit | Multi-unit |
The Indications for Use Statement for the subject device is similar to the primary predicate device K173343, with the difference being the name of the device and the exclusion of removable dental prosthesis support. The limitation in the subject device Indications for Use Statement does not change the risk-based assessment of the subject device, nor does it result in the identification of any new risks or the modification of existing risks for the subject device. The difference limits the restorative options for the subject device implants to fixed prosthetic unit support, forgoing removable prosthetic unit support while maintaining the intended use of the subject device implants as placement of the device into the zygoma for rehabilitation of the edentulous maxilla.
The primary predicate device K173343 is for substantial equivalence of the subject device implant designs. The subject device ZAGA Regular zygomatic implants have a design that is substantially equivalent design to implants in K173343, specifically the Zygan zygomatic implants. Similarly, the subject device ZAGA Advanced zygomatic implants have a design that is substantially equivalent design to implants in K173343, specifically the Oncology and Zygan zygomatic implants, with the only difference being the buccal-face of the implant coronal region. This feature of the ZAGA Advanced zygomatic implant does not negatively impact the mechanical performance of the implant.
6
The primary predicate device K173343 also serves as the primary predicate for substantial equivalence of the subject device screw-retained abutment designs.
The reference device K163634 is for the substantial equivalence of the subject device screw-retained abutment implant prosthetic diameter, material and surface treatment. The reference device K181703 is for the substantial equivalence of the subject device screw-retained abutment collar diameter, and abutment collar height.
The subject device implants incorporate the same materials and encompass similar ranges of dimensions as the predicate device cleared in K173343. The surface treatment applied to the endosseous threads of the subject device implants is identical to that cleared in K173343. The material and surface treatment applied to the subject device abutments is identical to that of the healing abutments cleared in K163634. All subject device components are for single-patient, single-use, and all are provided sterile. Similarly, the components cleared in the primary predicate K173343 are for single-patient, single-use and are provided sterile.
Substantial equivalence of the subject device components in terms of biocompatibility is supported by the fact that materials are identical in formulation, processing, component interactions, and storage conditions to the predicate devices in K173343.
In support of substantial equivalence in terms of mechanical performance, dynamic compression-bending testing was performed according to ISO 14801. The results from the testing demonstrated fatigue performance of the subject device to be substantially equivalent to that of the primary predicate K173343.
CONCLUSION
The subject device and the predicate devices have intended use, have similar technological characteristics, and are made of the same materials. The subject device and the predicate devices encompass the same range of physical dimensions, including diameter and length of the implants, and the diameter and angulation of the abutments. The subject device and the predicate devices are packaged in similar materials and sterilized using similar methods.
The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.