Provata Implant System
Device Facts
| Record ID | K180465 |
|---|---|
| Device Name | Provata Implant System |
| Applicant | Southern Implants (Pty), Ltd. |
| Product Code | DZE · Dental |
| Decision Date | Sep 6, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Provata Implant System is intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading. The Provata Implant System is intended for immediate function when good primary stability with appropriate occlusal loading is achieved.
Device Story
Provata Implant System consists of threaded root-form dental implants with internal hexagon interface and mating abutments; includes straight and Co-Axis (12º inclined) designs. Implants are surgically placed in upper or lower jaw by dental professionals. System includes cover screws, healing abutments, titanium cylinder abutments, cosmetic abutments, passive abutments, and compact conical abutments. Components are used to support prosthetic restorations (crowns, bridges, overdentures). Device provides means for prosthetic attachment; supports immediate function if primary stability is achieved. Benefits include restoration of dental function and aesthetics. Components are manufactured from unalloyed titanium (ASTM F67) or titanium alloy (ASTM F136).
Clinical Evidence
No clinical data included. Substantial equivalence supported by non-clinical bench testing: biocompatibility, engineering/dimensional analysis, sterilization validation, and static/dynamic compression-bending testing per ISO 14801.
Technological Characteristics
Threaded root-form dental implants with internal hex interface. Materials: Unalloyed titanium (ASTM F67) and titanium alloy (ASTM F136). Surface: Grit-blasted endosseous threads, machined collar. Dimensions: 4.0mm and 4.7mm diameters; 8.5-18mm lengths. Sterilization: Sterile (ISO 11137) or moist heat (Passive Abutments).
Indications for Use
Indicated for surgical placement in the upper or lower jaw for prosthetic attachment of crowns, bridges, or overdentures in patients requiring dental implants, utilizing delayed or immediate loading when good primary stability is achieved.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- External Hex Implants (K163634)
Reference Devices
- MIS Dental Implant System (K040807)
- Endosseous Dental Implant System (K070905)
- Endosseous Dental Implant System (K053478)
- Deep Conical (DC) Implants and Accessories (K163060)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
Southern Implants (Pty) Ltd % Kevin A. Thomas, PhD Vice President and Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K180465
Trade/Device Name: Provata Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: July 24, 2018 Received: July 25, 2018
Dear Kevin A. Thomas, PhD:
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.
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
September 6, 2018
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/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.
forTina 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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# Indications for Use
# K180465
Device Name
Provata Implant System
Indications for Use (Describe)
The Provata Implant System is intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading. The Provata Implant System is intended for immediate function when good primary stability with appropriate occlusal loading is achieved.
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|
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
### K180465
### Provata Implant System
### Southern Implants (Pty) Ltd
September 4, 2018
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Southern Implants (Pty) Ltd<br>1 Albert Road<br>Irene, Gauteng, 0062 South Africa | |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| | Telephone | +27 12 667 1046 |
| | Fax | +27 12 667 1029 |
| Official Contact | Lauranda G. Breytenbach<br>Head of Regulatory Affairs and Quality | |
| Representative/Consultant | Kevin A. Thomas, PhD<br>Floyd G. Larson, MS,<br>MBA PaxMed<br>International, LLC<br>12264 El Camino Real, Suite 400<br>San Diego, CA 92130 | |
| | Telephone: | +1 858-792-1235 |
| | Fax: | +1 858-792-1236 |
| | Email: | kthomas@paxmed.com<br>flarson@paxmed.com |
#### DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | Provata Implant System |
|------------------------|-----------------------------|
| Common Name | Dental implant and abutment |
Classification Name Classification Regulation Device Class Product Code
Endosseous Dental Implant 21 CFR 872.3640 Class II DZE, NHA
Classification Panel Reviewing Branch
Dental Products Panel Dental Devices Branch
#### PREDICATE DEVICE INFORMATION
The primary predicate:
K163634, External Hex Implants, Southern Implants (Pty) Ltd The reference devices are: K040807, MIS Dental Implant System, MIS-Implant Technologies Limited K070905, Endosseous Dental Implant System, Southern Implants, Inc. K053478, Endosseous Dental Implant System, Northern Implants, LLC K163060, Deep Conical (DC) Implants and Accessories, Southern Implants (Pty) Ltd
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### INDICATIONS FOR USE STATEMENT
The Provata Implant System is intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading. The Provata Implant System is intended for immediate function when good primary stability with appropriate occlusal loading is achieved.
### SUBJECT DEVICE DESCRIPTION
This submission includes threaded root-form dental implants with an internal hexagon interface and mating abutments. The implants are provided in two designs: Straight and Co-Axis (prosthetic platform inclined 12º from orthogonal to the implant). The Straight and Co-Axis implants are each provided in two diameters, 4.0 mm (actual major diameter 4.07 mm tapering to 2.6 mm), and 4.7 mm (actual major diameter 4.70 mm tapering to 3.13 mm), in one prosthetic diameter (3.575 mm), and in overall lengths of 8.5, 10, 11.5, 13, 15, 18 mm. The Co-Axis implants are to be used with straight abutments only.
This submission also includes: a Cover Screw (one design/size); Healing Abutments in three diameters (3.7, 4.5, and 5.5 mm) each in three gingival heights (3, 4, and 6 mm); Titanium Cylinder Abutments for temporary restorations in one size and two designs (engaging and non-engaging); Cosmetic Abutments in straight (0°), 12°, and 24° angled engaging designs for single-unit restorations; Passive Abutments with a plastic burn-out component, in one size and two designs (engaging); Compact Conical Abutments in straight (0°), 20°, and 30° angled designs for multi-unit restorations; and abutment screws.
All Provata implants are manufactured from unalloyed titanium conforming to ASTM F67, with a smooth machined collar. The remainder of the implant (the entire endosseous threaded surface) is grit-blasted. The subject device implant material and surface is identical to the implants cleared in K163634. The Cover Screw and all abutments (except Compact Conical) are manufactured from unalloyed titanium conforming to ASTM F67. The Compact Conical Abutments are manufactured from titanium alloy conforming to ASTM F136. The abutment screws are manufactured from titanium alloy conforming to ASTM F136, or gold-platinum alloy. All subject device components are manufactured in the same facilities using the same materials and manufacturing processes as used for the Southern Implants devices previously cleared in K163634 and K163060.
### PERFORMANCE DATA
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility (referenced from K163634 and K163060); engineering analysis; dimensional analysis; sterilization validation according to ISO 11137-1, ISO 11137-2, ISO 17665-1, ISO TS 17665-2; bacterial endotoxin according to USP 39-NF34; sterile barrier shelf life (referenced from K163634); and static and dynamic compression-bending according to ISO 14801. No clinical data were included in this submission.
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# 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 devices, the substantially equivalent in indications and design principles to the following legally marketed devices:
K163634, External Hex Implants, Southern Implants (Pty) Ltd K040807, MIS Dental Implant System, MIS-Implant Technologies Limited K070905, Endosseous Dental Implant System, Southern Implants, Inc. K053478, Endosseous Dental Implant System, Northern Implants, LLC K163060, Deep Conical (DC) Implants and Accessories, Southern Implants (Pty) Ltd
The primary predicate device is K163634. The reference devices are K040807, K070905, K053478, and K163060.
A comparison of the technological characteristics of the subject device and the primary predicate device K163634 is provided in the following table.
| Comparison | Subject Device | Primary Predicate Device |
|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | K180465 | K163634 |
| | Provata Implant System | External Hex Implants |
| | Southern Implants (Pty) Ltd | Southern Implants (Pty) |
| Indications for Use Statement | The Provata Implant System is intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading. The Provata Implant System is intended for immediate function when good primary stability with appropriate occlusal loading is achieved. | Southern Implants' External Hex Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading. Southern Implants' External Hex Implants are intended for immediate function when good primary stability with appropriate occlusal loading is achieved. |
| Implant Design | | |
| Implant Diameter | 4.07 mm, 4.7 mm | 4.07 mm, 4.7 mm |
| Implant Length | 8.5, 10, 11.5, 13, 15, 18 mm | 8.5, 10, 11.5, 13, 15, 18 mm |
| Platform Angle,<br>Relative to orthogonal to implant long axis | 0° and angled 12° (inclined) | 0° and angled 12° (inclined) |
| Implant Platform Diameter | 3.87 mm, 3.75 mm | 3.43 mm, 4.07 mm, 5.0 mm |
| Implant Prosthetic Diameter | 3.575 mm | 3.43 mm, 4.07 mm, 5.0 mm |
| Implant Interface | Internal Hex | External Hex |
| Material | Unalloyed titanium (ASTM F67) | Unalloyed titanium (ASTM F67) |
| Implant endosseous surface | Grit-blasted | Grit-blasted |
| Cover Screw | | |
| Platform diameter | 3.575 mm | 3.5 mm, 5.0 mm |
| Maximum diameter | 3.61 mm | 3.5 mm, 5.35 mm |
| Material | Unalloyed titanium (ASTM F67) | Unalloyed titanium (ASTM F67) |
| Healing Abutment | | |
| Collar height | 3, 4, 6 mm | 2.2, 3, 4, 5, 6, 8 mm |
| Collar diameter | 3.7, 4.5, 5.5 mm | 3.6, 4.5, 5.5, 6.5, 7.5 mm |
| Material | Unalloyed titanium (ASTM F67) | Unalloyed titanium (ASTM F67) |
| Titanium Cylinder Abutment | | |
| Connection configurations | Engaging and non-engaging;<br>Single-unit and multi-unit | Engaging and non-engaging;<br>Single-unit and multi-unit |
| Prosthesis Attachment | Cement-retained | Cement-retained |
| Collar height | 2 mm | 1 mm, 5 mm |
| Collar diameter | 4.0 mm | 4.3 mm, 5 mm, 6 mm |
| Abutment Angle | 0° | 0° |
| Abutment Material | Unalloyed titanium (ASTM F67) | Unalloyed titanium (ASTM F67) |
| Abutment Screw Material | Titanium alloy (ASTM F136) or gold alloy | Titanium alloy (ASTM F136) or gold alloy |
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| Comparison | Subject Device | Primary Predicate Device |
|---------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------------|
| | K180465<br>Provata Implant System<br>Southern Implants (Pty) Ltd | K163634<br>External Hex Implants<br>Southern Implants (Pty) |
| Cosmetic Abutment | | |
| Connection configurations | Engaging; Single-unit | Engaging; Single-unit |
| Prosthesis Attachment | Cement-retained | Cement-retained |
| Collar height | Varying from 1.6 mm to 2.9 mm | Varying from 1.6 mm to 2.9 mm |
| Collar diameter | Varying from 4.68 mm to 5.25 mm | Varying from 5 mm to 7.5 mm |
| Abutment Angle | 0°, 12°, and 24° | 0°, 12°, and 24° |
| Abutment Material | Unalloyed titanium (ASTM F67) | Unalloyed titanium (ASTM F67) |
| Abutment Screw Material | Titanium alloy (ASTM F136) or gold alloy | Titanium alloy (ASTM F136) or gold alloy |
| Passive Abutment | | |
| Connection configurations | Engaging and non-engaging;<br>Single-unit and multi-unit | Engaging and non-engaging;<br>Single-unit and multi-unit |
| Prosthesis Attachment | Screw-retained | Screw-retained |
| Collar height | 0.4 mm | 0.4 mm |
| Collar diameter | 3.61 mm | 3.43, 4.07, 5.0, 6.0 mm |
| Abutment Angle | 0° | 0° |
| Abutment Material | Unalloyed titanium (ASTM F67) | Unalloyed titanium (ASTM F67) |
| Abutment Screw Material | Titanium alloy (ASTM F136) or gold alloy | Titanium alloy (ASTM F136) or gold alloy |
| Compact Conical Abutment | | |
| Connection configurations | 0°: Non-engaging; Multi-unit<br>20° and 30°: Engaging; Multi-unit | 0°: Non-engaging; Multi-unit<br>17° and 30°: Engaging; Multi-unit |
| Prosthesis Attachment | Screw-retained | Screw-retained |
| Collar height | 0°: 1, 3, 5 mm<br>20°: 1.21 mm - 2.85 mm<br>30°: 1.21 mm - 2.85 mm | 0°: 1.5, 2, 3, 4, 5.5 mm<br>17°: 1.5 mm – 2.9 mm<br>30°: 1.3 mm – 3.7 mm |
| Collar diameter | 4.8 mm | 4.8 mm, 6.0 mm |
| Abutment Angle | 0°, 20°, 30° | 0°, 17°, and 30° |
| Abutment Material | Titanium alloy (ASTM F136) | Titanium alloy (ASTM F136) |
| Abutment Screw Material | Titanium alloy (ASTM F136) | Titanium alloy (ASTM F136) |
The Indications for Use Statement for the subject device is the same as that of the primary predicate device K163634, except for the names of the devices.
The primary predicate device K163634 is for substantial equivalence of the subject device implant design. The subject device implants have the identical design as implants in K163634 with the exception of the internal connection interface. The reference device K040807 is for substantial equivalence of the subject device internal connection interface. The implants cleared in K040807 also have the same range of implant diameter, the same range of implant, and the same material as the subject device implants.
The primary predicate device K163634 also is for substantial equivalence of the subject device Cover Screw, Healing Abutment, Titanium Cylinder Abutment, Cosmetic Abutment, Passive Abutment, and Compact Conical Abutment designs.
The reference device K070905 is for substantial equivalence of the subject device Cover Screw material and internal connection; Healing Abutment collar height, collar diameter, and material; Titanium Cylinder connection and material with anodization; and Cosmetic Abutment connection, collar height, and material.
The reference device K053478 is for substantial equivalence of the subject device Passive Abutments internal connection and titanium alloy material.
The subject device Compact Conical Abutment has the identical TiN coating on Ti-6Al-4V alloy as overdenture abutments cleared in the reference device K163060.
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The subject device and the predicate and reference devices all incorporate the same materials and encompass similar ranges of dimensions. The surface treatment applied to the endosseous threads of the subject device implants is identical to that cleared in K163634. All subject device components are for single-patient, single-use, and all are provided sterile except for the subject device Passive Abutments, which are to be moist heat sterilized. Similarly, the components cleared in K163634 are for singlepatient, single-use and are provided sterile except for the Passive Abutments, which are to be moist heat sterilized.
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 primary predicate device K163634 and reference device K163060.
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 predicate device K 163634.
# CONCLUSION
The subject device and the predicate and reference devices have intended use, have similar technological characteristics, and are made of similar materials. The subject device and the predicate and reference 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 and reference devices are packaged in similar materials and sterilized using similar methods.
The data included in this submission demonstrate substantial equivalence to the predicate and reference devices listed above.
