(230 days)
No
The summary describes physical dental implants and related components, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as an artificial root structure to replace missing teeth and/or support prostheses, which directly addresses a health condition (tooth loss) and restores function.
No
Explanation: The device is described as an endosseous dental implant intended to replace missing teeth and/or support prostheses. There is no mention of it being used to diagnose conditions.
No
The device description clearly details physical components made of titanium alloy, such as implant fixtures, abutments, healing caps, and cover screws. This indicates it is a hardware medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Implanova® Bone Level implants are for "endosseous implantation in the mandible and maxilla for use as an artificial root structure." This describes a surgical implant, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Device Description: The device description details the physical characteristics, materials, and components of dental implants, abutments, healing caps, and cover screws. These are all physical devices intended for surgical placement and support of dental prostheses.
- Lack of IVD Characteristics: The text does not mention any components, processes, or intended uses related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing diagnostic information based on laboratory testing
- Compatibility testing (like blood typing)
The device is a medical device, specifically a dental implant system, intended for surgical use.
N/A
Intended Use / Indications for Use
The Implanova® Bone Level implants are intended for endosseous implantation in the mandible and maxilla for use as an artificial root structure. These root form implants can be used to replace single or multiple missing teeth and/or to support a fixed or removable prosthesis in partially or completely edentulous upper and lower dental arches. All devices in the Implanova® Bone Level system, including implant fixtures, abutments, healing caps, cover screws, and retention screws are intended for use by prescription only. Implanova® Bone Level implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Implanova® All-in-One3.0mm implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the mandibular central and lateral incisor and maxillary lateral incisor regions of partially edentulous jaws. The Implanova® All-in-One 3.0mm implant must be splinted if two or more are used adjacent to each other. Implanova® All-in-One 3.0mm implant are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
All Implanova® Bone Level implant fixtures are compatible with the straight type restorative components listed in the table below, including straight type abutments, straight type abutment screws and straight type temporary abutments that are intended to be on Astra Tech's OsseoSpeedTM TX 3.5S and OsseoSpeedTM TX 4.0S implant fixtures.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
All bone fixtures within Inplanova® system are endosseous dental implants and are available in Bone Level and All-In-One implants types. Fixtures are available in the following sizes.
· IMPLANOVA® BONE LEVEL IMPLANTS
Narrow Medium: 3.5mm Diameter x 10mm Length
Narrow Long: 3.5mm Diameter x 12mm Length
Narrow XLong (Extra Long): 3.5mm Diameter x 14mm Length
Standard Short: 4.5mm Diameter x 8mm Length
Standard Medium: 4.5mm Diameter x 10mm Length
Standard Long: 4.5mm Diameter x 12mm Length
Standard XLong: 4.5mm Diameter x 14mm Length
Wide Short: 5.5mm Diameter x 8mm Length
Wide Medium: 5.5mm Diameter x 10mm Length
Wide Long: 5.5mm Diameter x 12mm Length
· IMPLANOVA® ALL-IN-ONE IMPLANTS
Slender Medium: 3.0mm Diameter x 10mm Length
Slender Long: 3.0mm Diameter x 12mm Length
Slender XLong (Extra Long): 3.0mm Diameter x 14mm Length
The material constituents of the all implant fixtures within the Implanova® system is Grade 23 Titanium Alloy per ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vnadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). In order to promote osseointegration, a variable portion of the implant surface, depending on the implant's overall length, is surface treated and passivated per ASTM F86 standard.
Abutments for bone level implants are utilized for cement retained restoration. Bone level abutments are available in straight and angled types as well as platform sizes ranging from 4.2mm to 6.5mm. All bone level angled abutments will utilize their respective abutment screw for installation. The material constituents of all Implanova® abutments is grade 23titanium alloy per ASTM F136 Standard Specification for Wrought Titanium
6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).
Implanova® Bone Level Abutments offer the following models.
IMPLANOVA® BONE LEVEL ABUTMENTS
Narrow Platform - Straight: 4.2 mm Platform Diameter x 5.7 mm Post Height
Narrow Platform – 15 Degrees: 4.2 mm Platform Diameter x 7.3 mm Post Height
Narrow Platform – 20 Degrees: 4.2 mm Platform Diameter x 7.3 mm Post Height
Standard Platform - Straight: 4.8 mm Platform Diameter x 5.7 mm Post Height
StandardPlatform – 15 Degrees: 4.8 mm Platform Diameter x 7.3 mm Post Height
StandardPlatform – 20 Degrees: 4.8 mm Platform Diameter x 7.3 mm Post Height
Wide Platform - Straight: 6.5 mm Platform Diameter x 5.7 mm Post Height
WidePlatform - 15 Degrees: 6.5 mm Platform Diameter x 7.3 mm Post Height
WidePlatform - 20 Degrees: 6.5 mm Platform Diameter x 7.3 mm Post Height
The system also offers Healing Caps and Cover Screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible and maxilla
Indicated Patient Age Range
Not Found
Intended User / Care Setting
prescription only.
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)
The following testing was performed and the test results supported that the subject device is substantially equivalent to the predicate devices and it is in conformance with the FDA guidance document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments.
- · Fatigue Testing according to ISO 14801
- 3"d Party Compatibility
- · Sterilization Validationaccording to ISO 11137-1, ISO 11137-2, ISO11737-1, ISO11737-2, ISO 17665-1 and ISO 17665-2
- · Shelf-life Validation according to ASTM F1980, ISO 11607-1, ISO 11607-2, ASTM F88, and ASTM F 1929
- · Cytotoxicity Testing according to ISO 10993-5
- SEM/EDS Chemical Surface Analysis
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.
K073268, K132956, K052997, K070857, K101005, K072624, K130808, K071585, K062129, K130808, K070478, K960634, K080156
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 27, 2015
Dental Evolutions Inc. c/o Ms. Priscilla Chung LK Consulting Group USA, Inc. 2651 East Chapman Avenue Suite 110 Fullerton, California 92831
Re: K150040
Trade/Device Name: Implanova® Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: July 23, 2015 Received: July 28, 2015
Dear Ms. Chung:
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.
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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150040
Device Name
Implanova®
Indications for Use (Describe)
The Implanova® Bone Level implants are intended for endosseous implantation in the mandible and maxilla for use as an artificial root structure. These root form implants can be used to replace single or multiple missing teeth and/or to support a fixed or removable prosthesis in partially or completely edentulous upper and lower dental arches. All devices in the Implanova® Bone Level system, including implant fixtures, abutments, healing caps, cover screws, and retention screws are intended for use by prescription only. Implanova® Bone Level implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Implanova® All-in-One3.0mm implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the mandibular central incisor and maxillary lateral incisor regions of partially edentulous jaws. The Implanova® All-in-One 3.0mm implant must be splinted if two or more are used adjacent to each other. Implanova® All-in-One 3.0mm implant are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
All Implanova® Bone Level implant fixtures are compatible with the straight type restorative components listed in the table below, including straight type abutments, straight type abutment screws and straight type temporary abutments that are intended to be on Astra Tech's OsseoSpeed 11 TX 3.5S and OsseoSpeed "M TX 4.0S implant fixtures.
| Implanova® Bone Level to Astra Tech Compatibility List | ||||
|---|---|---|---|---|
| Component Type | Part # | Device Name | Manufacturer | Compatible Implanova® Bone |
| Level Fixtures | ||||
| Healing Abutment | 22851 | TempDesignTM3.5/4.0 | Astra Tech | All Bone Level Implants |
| Healing Abutment | 22853 | TempDesignTM3.5/4.0 NI | Astra Tech | All Bone Level Implants |
| Healing Abutment | 24281 | Temporary Abutment 3.5/4.0 | Astra Tech | AllBone Level Implants |
| Healing Abutment | 24280 | Temporary Abutment 3.5/4.0 NI | Astra Tech | AllBone Level Implants |
| Abutment Screw | 24449 | Abutment Screw Design 3.5/4.0 | Astra Tech | AllBone Level Implants |
| Abutment | 24910 - 24916 | Direct AbutmentTM3.5/4.0 | Astra Tech | AllBone Level Implants |
| Abutment | 24917 - 24923 | Direct Abutment APITM3.5/4.0 | Astra Tech | AllBone Level Implants |
| Abutment | 24893 - 24898 | 20° UniAbutment 3.5/4.0 | Astra Tech | AllBone Level Implants |
| Abutment | 24899 - 24904 | 45° UniAbutment 3.5/4.0 | Astra Tech | AllBone Level Implants |
| Abutment | 24905 - 24909 | Ball Abutment 3.5/4.0 | Astra Tech | AllBone Level Implants |
| Abutment | 24268 - 24272 | LocatorTM Abutment 3.5/4.0 | Astra Tech | AllBone Level Implants |
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.
3
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4
510(k) Summary
This summary of 510(K) is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: 08/24/2015
1. Applicant / Submitter
Dental Evolutions Inc. 9100 Wilshire Blvd. Suite W448 Beverly Hills, CA 90212
Phone. 310.273.2819 Fax. 310. 273.3319
2. Submission Correspondent
Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave. Ste 110, Fullerton CA 92831 Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device
- Trade Name: Implanova® י
- . Common Name: Dental Implant System
- Classification Name: Endosseous Dental Implant ■
- Product Code: DZE, NHA '
- י Classification regulation: 21CFR872.3640 Class II
4. Predicate Device:
-
Primary Predicate Device
-
. BioHorizons Tapered Internal Plus Implants by BioHorizons Implant Systems, Inc. (K121787)
-
Reference Predicate Devices
-
BioHorizons Internal Implants by BioHorizons Implant Systems, Inc. (K073268) l
-
U fit Dental Implant System by T Strong Inc. (K132956) י
-
Zimmer One-Piece Implant System by Zimmer Dental Inc. (K052997) י
-
NobelDirect 3.0 by Nobel Biocare USA LLC (K070857) י
5
- י Astra Tech Implant System, New Components , Angled TiDesign Abutment by Astra Tech AB (K101005, K072624)
- י NC Closure Screws, Straumann Closure Screws by Straumann USA (K130808. K071585)
- י Straumann Healing Abutments, RC Closure Screws, RC Healing Abutments by Straumann USA(K062129, K130808, K070478, K960634)
- י OsseoSpeed™ Profile System by Astra Tech AB (K080156)
5. Description:
All bone fixtures within Inplanova® system are endosseous dental implants and are available in Bone Level and All-In-One implants types. Fixtures are available in the following sizes.
· IMPLANOVA® BONE LEVEL IMPLANTS Narrow Medium: 3.5mm Diameter x 10mm Length Narrow Long: 3.5mm Diameter x 12mm Length Narrow XLong (Extra Long): 3.5mm Diameter x 14mm Length
Standard Short: 4.5mm Diameter x 8mm Length Standard Medium: 4.5mm Diameter x 10mm Length Standard Long: 4.5mm Diameter x 12mm Length Standard XLong: 4.5mm Diameter x 14mm Length
Wide Short: 5.5mm Diameter x 8mm Length Wide Medium: 5.5mm Diameter x 10mm Length Wide Long: 5.5mm Diameter x 12mm Length
· IMPLANOVA® ALL-IN-ONE IMPLANTS Slender Medium: 3.0mm Diameter x 10mm Length Slender Long: 3.0mm Diameter x 12mm Length Slender XLong (Extra Long): 3.0mm Diameter x 14mm Length
The material constituents of the all implant fixtures within the Implanova® system is Grade 23 Titanium Alloy per ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vnadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). In order to promote osseointegration, a variable portion of the implant surface, depending on the implant's overall length, is surface treated and passivated per ASTM F86 standard.
Abutments for bone level implants are utilized for cement retained restoration. Bone level abutments are available in straight and angled types as well as platform sizes ranging from 4.2mm to 6.5mm. All bone level angled abutments will utilize their respective abutment screw for installation. The material constituents of all Implanova® abutments is grade 23titanium alloy per ASTM F136 Standard Specification for Wrought Titanium
6
6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).
Implanova® Bone Level Abutments offer the following models.
· IMPLANOVA® BONE LEVEL ABUTMENTS
Narrow Platform - Straight: 4.2 mm Platform Diameter x 5.7 mm Post Height Narrow Platform – 15 Degrees: 4.2 mm Platform Diameter x 7.3 mm Post Height Narrow Platform – 20 Degrees: 4.2 mm Platform Diameter x 7.3 mm Post Height
Standard Platform - Straight: 4.8 mm Platform Diameter x 5.7 mm Post Height StandardPlatform – 15 Degrees: 4.8 mm Platform Diameter x 7.3 mm Post Height StandardPlatform – 20 Degrees: 4.8 mm Platform Diameter x 7.3 mm Post Height
Wide Platform - Straight: 6.5 mm Platform Diameter x 5.7 mm Post Height WidePlatform - 15 Degrees: 6.5 mm Platform Diameter x 7.3 mm Post Height WidePlatform - 20 Degrees: 6.5 mm Platform Diameter x 7.3 mm Post Height
The system also offers Healing Caps and Cover Screws.
OsseoSpeed™ Profile System (K080156) is identified as a referenced predicated as the Implanova Bone Level Implant are compatible with the 3t party straight abutment listed in the Indications for Use and cleared in K080156.
6. Indications for use:
The Implanova® Bone Level implants are intended for endosseous implantation in the mandible and maxilla for use as an artificial root structure. These root form implants can be used to replace single or multiple missing teeth and/or to support a fixed or removable prosthesis in partially or completely edentulous upper and lower dental arches. All devices in the Implanova® Bone Level system, including implant fixtures, abutments, healing caps, cover screws, and retention screws are intended for use by prescription only. Implanova® Bone Level implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Implanova® All-in-One3.0mm implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the mandibular central and lateral incisor and maxillary lateral incisor regions of partially edentulous jaws. The Implanova® All-in-One 3.0mm implant must be splinted if two or more are used adjacent to each other. Implanova® All-in-One 3.0mm implant are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
All Implanova® Bone Level implant fixtures are compatible with the straight type restorative components listed in the table below, including straight type abutments,
7
straight type abutment screws and straight type temporary abutments that are intended to be on Astra Tech's OsseoSpeed™ TX 3.5S and OsseoSpeed™ TX 4.0S implant fixtures.
| Implanova®Bone Level to Astra Tech Compatibility List | |||||
|---|---|---|---|---|---|
| Component Type | Part # | Device Name | Manufacturer | Compatible Implanova® Bone | |
| Level Fixtures | |||||
| Healing Abutment | 22851 | TempDesign™3.5/4.0 | Astra Tech | All Bone Level Implants | |
| Healing Abutment | 22853 | TempDesign "3.5/4.0 NI | Astra Tech | All Bone Level Implants | |
| Healing Abutment | 24281 | Temporary Abutment 3.5/4.0 | Astra Tech | AllBone Level Implants | |
| Healing Abutment | 24280 | Temporary Abutment 3.5/4.0 NI | Astra Tech | AllBone Level Implants | |
| Abutment Screw | 24449 | Abutment Screw Design 3.5/4.0 | Astra Tech | AllBone Level Implants | |
| Abutment | 24910 - 24916 | Direct Abutment'10"3.5/4.0 | Astra Tech | AllBone Level Implants | |
| Abutment | 24917 - 24923 | Direct Abutment API"3.5/4.0 | Astra Tech | AllBone Level Implants | |
| Abutment | 24893 - 24898 | 20° UniAbutment 3.5/4.0 | Astra Tech | AllBone Level Implants | |
| Abutment | 24899 - 24904 | 45° UniAbutment 3.5/4.0 | Astra Tech | AllBone Level Implants | |
| Abutment | 24905 - 24909 | Ball Abutment 3.5/4.0 | Astra Tech | AllBone Level Implants | |
| Abutment | 24268 - 24272 | Locator™ Abutment 3.5/4.0 | Astra Tech | AllBone Level Implants |
7. Basis for Substantial Equivalence
Implanova® is substantially equivalent to previously marketed devices. Overall, the Implanova® has the following similarities to the predicate devices:
- has the same intended use,
- uses the same operating principle,
- I incorporates the same basic design,
- incorporates the same material and the surface treatment.
- I has similar size range
The subject device is similar to the predicate devices based on the intended use, the principle of operations, the materials, the surface treatment, the size range and the technological characteristics. The external design of the subject device is slightly different from the predicate devices; however, the performance testing provided in this 510K submission supports that the subject device is substantially equivalent to the predicate devices.
The detailed comparison chart is provided on the following pages.
8
| Subject Device | Primary Predicate Device | Reference Predicate Device1 | Reference Predicate Device2 | |
|---|---|---|---|---|
| 510(K) Number | K121787 | K073268 | K132956 | |
| Device Name | Implanova® Bone Level | |||
| Implant | BioHorizons Tapered Internal Plus | |||
| Implants | BioHorizons Internal Implants | U fit Dental Implant System | ||
| Manufacturer | Dental Evolutions Inc. | BioHorizons Implant Systems, Inc. | BioHorizons Implant Systems, | |
| Inc. | T Strong Inc. | |||
| Connection | ||||
| Type | Internal Hexagon | Internal Hexagon | Internal Hexagon | Internal Hexagon |
| Size Range | Diameter: 3.5mm, 4.5mm, | |||
| 5.5mm | ||||
| Length: 8mm (excluding 3.5mm | ||||
| diameter), 10mm, 12mm, 14mm | ||||
| (excluding 5.5mm diameter) | Diameter: 3.8mm, 4.6mm, 5.8mm | |||
| Length: 7.5mm (excluding 3.8mm | ||||
| diameter), 9mm, 10.5mm, 12mm, | ||||
| 15mm | Diameter: 3.5mm, 4.0mm, | |||
| 5.0mm, 6.0mm | ||||
| Length: 9mm, 10.5mm, 12mm, | ||||
| 15mm | Diameter: 3.8mm, 3.9mm, | |||
| 4.0mm, 4.2mm, 4.5mm, 5.0mm, | ||||
| 5.5mm, 6.0mm, 7.0mm | ||||
| Length: 7mm, 8.5mm, 10mm, | ||||
| 11.5mm, 13mm, 14.5mm | ||||
| Indications for | ||||
| Use | The Implanova® Bone Level | |||
| implants are intended for | ||||
| endosseous implantation in the | ||||
| mandible and maxilla for use as | ||||
| an artificial root structure. | ||||
| These root form implants can be | ||||
| used to replace single or | ||||
| multiple missing teeth and/or to | ||||
| support a fixed or removable | ||||
| prosthesis in partially or | ||||
| completely edentulous upper | ||||
| and lower dental arches. All | ||||
| devices in the Implanova® | ||||
| Bone Level system, including | ||||
| implant fixtures, abutments, | ||||
| healing caps, cover screws, and | ||||
| retention screws are intended | ||||
| for use by prescription only. | ||||
| Implanova® Bone Level | ||||
| implants are intended for | ||||
| immediate loading when good | ||||
| primary stability is achieved | ||||
| and with appropriate occlusal | ||||
| loading. | BioHorizons Tapered Internal Plus | |||
| Implants are intended for use in the | ||||
| mandible or maxilla as an artificial | ||||
| root structure for single tooth | ||||
| replacement or for fixed bridge | ||||
| work and dental retention. | ||||
| Theimplants may be restored | ||||
| immediately (1) with | ||||
| atemporaryprosthesis that is not in | ||||
| functional occlusion or (2) when | ||||
| splinted together for multipletooth | ||||
| replacement or when stabilized | ||||
| with an overdenture supported by | ||||
| multiple implants. | BioHorizons Internal Implants are | |||
| intended for use in the mandible or | ||||
| maxilla as an artificial root | ||||
| structure for single tooth | ||||
| replacement or for fixed | ||||
| bridgework and dental retention. | ||||
| BioHorizons Internal Implants | ||||
| may be restored immediately (1) | ||||
| with a temporary prosthesis that is | ||||
| not in functional occlusion, or (2) | ||||
| when splinted together for | ||||
| multiple tooth replacement, or | ||||
| when stabilized with an | ||||
| overdenture supported by multiple | ||||
| implants. | The U fit Dental Implant | |||
| System is indicated for use in | ||||
| partially or fully edentulous | ||||
| mandibles and maxillae, in | ||||
| support of single or multiple- | ||||
| unit restorations including; | ||||
| cemented retained, screw | ||||
| retained, or overdenture | ||||
| restorations, and terminal or | ||||
| intermediate abutment support | ||||
| for fixed bridgework. The U fit | ||||
| Dental Implant System is for | ||||
| single and two stage surgical | ||||
| procedures. It is intended for | ||||
| delayed loading. |
Comparative Table for Bone Level Implant
9
| | Implanova® All-in-One 3.0mm implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the mandibular central and lateral incisor and maxillary lateral incisor regions of partially edentulous jaws. The Implanova® All-in-One 3.0mm implant must be splinted if two or more are used adjacent to each other. Implanova® All-in-One 3.0mm implant are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
All Implanova® Bone Level implant fixtures are compatible with the straight type restorative components listed in the table below, including straight type abutments, straight type abutment screws and straight type temporary abutments that are intended to be on Astra Tech's OsseoSpeed™ TX 3.5S and OsseoSpeed™ TX 4.0S implant fixtures. | | | |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Design Characteristics | - Self-tapping
- Bone-level type implant
- Micro-threaded implant collar
- Tapered implant body | - Self-tapping
- Bone-level type implant
- Laser-Lok® microchannels implant collar
- Tapered implant body | - Self-tapping
- Bone-level type implant
- Laser-Lok® microchannels implant collar
- Tapered implant body | - Self-tapping
- Bone-level type implant
- Micro-threaded implant collar
- Tapered implant body |
| Material Composition | Titanium Alloy grade 23 (Ti6Al4V ELI) | Titanium Alloy grade 23 (Ti6Al4V ELI) | Titanium Alloy grade 23 (Ti6Al4V ELI) | Titanium Alloy grade 23 (Ti6Al4V ELI) |
| Surface Treatment | - Resorbable Blast Texture Media (calcium phosphate) | - Resorbable Blast Texture Media (calcium phosphate) | - Resorbable Blast Texture Media (calcium phosphate) | - Resorbable Blast Texture Media |
10
| - Partial surface treatment | ||||
|---|---|---|---|---|
| Sterile | Yes | Yes | Yes | Yes |
| Sterilization | ||||
| Method | Gamma Radiation | Gamma Radiation | Gamma Radiation | Gamma Radiation |
| Differences in | ||||
| Technological | ||||
| Characteristics | ||||
| (vs. subject | ||||
| device) | (Subject Device) | A notable difference, when | ||
| compared to the subject device, is | ||||
| the Laser-Lok® micro-machined | ||||
| grooves on this predicate device | ||||
| and the micro threads on the | ||||
| cervical area of subject device. The | ||||
| Laser-Lok® feature on the | ||||
| predicate device and the | ||||
| microthreads on the subject device | ||||
| are functionally identical. They do | ||||
| not render the device NSE because | ||||
| the osteocytes cannot differentiate | ||||
| the microscopic differences in | ||||
| topography in osseointegration. | ||||
| Another notable difference when | ||||
| compared to the subject device, are | ||||
| the length of the flutes. Although | ||||
| the subject device exhibit longer | ||||
| flute lengths, flutes on both | ||||
| BioHorizon Tapered Internal | ||||
| Plus and the Implanova subject | ||||
| devices are designed for self- | ||||
| tapping (self-threading) and are | ||||
| functionally similar. This | ||||
| difference does not make the | ||||
| subject device NSE because more | ||||
| tapping edges simply ease the | ||||
| tapping processes but functions the | ||||
| same. | ||||
| Another notable difference | ||||
| between subject device and the | ||||
| predicate is the twist direction of | ||||
| the vertical flutes. The subject | A notable difference, when | |||
| compared to the subject device, is | ||||
| the Laser-Lok® micro-machined | ||||
| grooves on this predicate device | ||||
| and the micro threads on the | ||||
| cervical area of subject device. | ||||
| They do not render the device | ||||
| NSE because the osteocytes | ||||
| cannot differentiate the | ||||
| microscopic differences in | ||||
| topography in osseointegration. | ||||
| Another notable difference when | ||||
| compared to the subject device, | ||||
| are the length of the flutes. | ||||
| Although the subject device | ||||
| exhibit longer flute lengths, flutes | ||||
| on both BioHorizon Internal | ||||
| Implants and the Implanova | ||||
| subject devices are designed for | ||||
| self-tapping (self-threading) and | ||||
| are functionally similar. This | ||||
| difference does not make the | ||||
| subject device NSE because more | ||||
| tapping edges simply ease the | ||||
| tapping processes but functions | ||||
| the same. | ||||
| Another notable difference | ||||
| between subject device and the | ||||
| predicate is the twist direction of | ||||
| the vertical flutes. The subject | ||||
| device's vertical flute is a very | ||||
| minor left hand twist (18mm | ||||
| pitch). Majority of implants in | A notable difference between | |||
| subject device and the predicate | ||||
| is the twist direction of the | ||||
| vertical flutes. The subject | ||||
| device's vertical flute is a very | ||||
| minor left hand twist (18mm | ||||
| pitch), while the predicate | ||||
| device possesses a slight right | ||||
| hand twist. The function of | ||||
| flutes in subject andpredicate | ||||
| device is to provide cutting | ||||
| edges for the tapping feature of | ||||
| the fixture as well as to provide | ||||
| clearances for the consolidation | ||||
| of swarf material (bone debris). | ||||
| The minor left hand helical twist | ||||
| of the subject device only | ||||
| slightly increases the sharpness | ||||
| of the edges of the implant's | ||||
| tapping features and passively | ||||
| guides the swarf materials to | ||||
| consolidate in the provided flute | ||||
| clearances. Thus, the slight | ||||
| helical twist of the subject | ||||
| device should not render the | ||||
| device NSE. | ||||
| Another notable difference | ||||
| between subject device and the | ||||
| predicate is the partial surface | ||||
| treatment of the subject device. | ||||
| While the surfaces of | ||||
| the predicate devices are | ||||
| modified throughout the implant | ||||
| body, the subject device is |
11
| device's vertical flute is a very
minor left hand twist (18mm
pitch). Majority of implants in
market including the predicate
device have a straight vertical
flute. The function of flutes in
subject andpredicate device is to
provide cutting edges for the
tapping feature of the fixture. The
minor left hand helical twist of the
subject device only slightly
increases the sharpness of the
edges of the implant's tapping
features and passively guides the
swarf materials to consolidate in
the provided flute clearances. | market including the predicate
device have a straight vertical
flute. The function of flutes in
subject andpredicate device is to
provide cutting edges for the
tapping feature of the fixture. The
minor left hand helical twist of the
subject device only slightly
increases the sharpness of the
edges of the implant's tapping
features and passively guides the
swarf materials to consolidate in
the
provided flute clearances. Thus,
the slight helical twist of the
subject device should not render
the device NSE. | modified throughout the body
except the apical 5 mm. Both
treated areas identically
functions in order to increase
surface area for
osseointegration. The subject
fixture's untreated apical area
maintains the sharpness of the
tapping edges for cutting
(tapping) of the bone. Since
surface treatment is not a
requirement for
osseointegration, this difference
does not make the subject
device NSE. (All original
Branemark implants were
machine finished and did not
have any surface treatments) |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Thus, the slight helical twist of the
subject device should not render
the device NSE. | Another notable difference
between subject device and the
predicate is the partial surface
treatment of the subject device.
While the surfaces of
the predicate devices are modified
throughout the implant body, the
subject device is modified
throughout the body except the
apical 5 mm. The subject fixture's
untreated apical area maintains
the sharpness of the tapping edges
for cutting (tapping) of the bone.
Since surface treatment is not a
requirement for osseointegration,
this difference does not make the
subject device NSE. (All original
Branemark implants were
machine finished and did not have
any surface treatments) | Despite these differences in
design, the fatiguetest result of
the subject device supports that
the subject device is
substantially equivalent to the
predicate devices. |
| Another notable difference
between subject device and the
predicate is the partial surface
treatment of the subject device.
While the surfaces of
the BioHorizons Tapered Internal
Plus implants are modified
throughout the implant body, the
subject device is modified
throughout the body except the
apical 5 mm. The subject fixture's
untreated apical area maintains the
sharpness of the tapping edges for
cutting (tapping) of the bone.
Since surface treatment is not a
requirement for osseointegration,
this difference does not make the
subject device NSE. (All original
Branemark implants were machine | | |
12
| finished and did not have any
surface treatments)
Despite these differences in design,
the fatiguetest result of the subject
device supports that the subject
device is substantially equivalent
to the predicate devices. | design, the fatiguetest result of the
subject device supports that the
subject device is substantially
equivalent to the predicate
devices. | |
| ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------- | -- |
|---|
Comparative Table for All-in-One Implant
| Subject Device | Reference Predicate Device | Reference Predicate Device | |
|---|---|---|---|
| 510(K) Number | K052997 | K070857 | |
| Device Name | Implanova® All-In-One Implant | Zimmer One-Piece Implant System | NobelDirect 3.0 |
| Manufacturer | Dental Evolutions Inc. | Zimmer Dental Inc. | Nobel Biocare USA LLC |
| Connection | |||
| Type | N/A | N/A | N/A |
| Design & Size | Diameter: 3.0mm | Diameter: 3.0mm | Diameter: 3.0mm |
| Range | Length: 10mm, 12mm, 14mm | Length: 10.0mm, 11.5mm, 13.0mm, 16.0mm | Length: 13.0mm, 15.0mm |
| Intended Use | The Implanova® Bone Level implants | ||
| are intended for endosseous implantation | |||
| in the mandible and maxilla for use as an | |||
| artificial root structure. These root form | |||
| implants can be used to replace single or | |||
| multiple missing teeth and/or to support | |||
| a fixed or removable prosthesis in | |||
| partially or completely edentulous upper | |||
| and lower dental arches. All devices in | |||
| the Implanova® Bone Level system, | |||
| including implant fixtures, abutments, | |||
| healing caps, cover screws, and retention | |||
| screws are intended for use by | |||
| prescription only. Implanova® Bone | |||
| Level implants are intended for | |||
| immediate loading when good primary | |||
| stability is achieved and with appropriate | |||
| occlusal loading. |
Implanova® All-in-One 3.0mm implants | Zimmer® One-Piece 3.7mm implants are
indicated for the support and retention of fixed
single tooth and fixed partial denture
restorations in the premolar, cuspid, and incisor
regions of partially edentulous jaws. Zimmer®
One-Piece 3.7mm implants may be loaded
immediately in the anterior mandibular arch if
four are splinted together with a bar. The
Zimmer® 3.7mm One-Piece implant may be
immediately restored with a temporary
prosthesis that is not in functional occlusion.
Zimmer® One-Piece 3.0mm implants are
indicated for the support and retention of fixed
single tooth and fixed partial denture
restorations in the mandibular central and
lateral incisor and maxillary lateral incisor
regions of partially edentulous jaws. The
Zimmer® One-Piece 3.0mm implant must be
splinted if two or more are used adjacent to | The Nobel Direct 3.0mm implant is indicated
for use in the treatment of missing maxillary
lateral incisors or the mandibular central and
lateral incisors to support prosthetic devices
such as artificial teeth, in order to restore
chewing function in partially edentulous
patients. The Nobel Direct 3.0 Implants may
be put into immediate function provided that
stability requirements detailed in the manual
are satisfied. Mandible central and lateral
incisors must be splinted if using two or more
3.0mm implants adjacent to one another. |
| | | | |
| | are indicated for the support and
retention of fixed single tooth and fixed
partial denture restorations in the
mandibular central and lateral incisor
and maxillary lateral incisor regions of
partially edentulous jaws. The
Implanova® All-in-One 3.0mm implant
must be splinted if two or more are used
adjacent to each other. Implanova® All-in-One 3.0mm implant are intended for
immediate loading when good primary
stability is achieved and with appropriate
occlusal loading.
All Implanova® Bone Level implant
fixtures are compatible with the straight
type restorative components listed in the
table below, including straight type
abutments, straight type abutment screws
and straight type temporary abutments
that are intended to be on Astra Tech's
OsseoSpeed™ TX 3.5S and
OsseoSpeed™ TX 4.0S implant fixtures. | each other. The Zimmer® One-Piece 3.0mm
implant may be immediately restored with a
temporary prosthesis that is not in functional
occlusion. | |
| Design
Characteristics | - Self-tapping
- Tissue-level type implant
- Micro-threaded implant collar
- Tapered implant body | - Self-tapping
- Tissue-level type implant | - Self-tapping
- Tissue-level type implant
- Full length tapping |
| Material
Composition | Titanium Alloy grade 23 (Ti6Al4V ELI) | Titanium Alloy grade 23 (Ti6Al4V ELI) | CP Titanium grade 4 |
| Surface
Treatment | - Resorbable Blast Texture Media
(calcium phosphate) - Partial surface treatment | - Hydroxyapatite (calcium phosphate group)
blast media | - TiUnite (phosphate enriched titanium oxide)
surface treatment |
| Sterile | Yes | Yes | Yes |
| Sterilization
Method | Gamma Radiation | Gamma Radiation | Gamma Radiation |
| Differences in
Technological
Characteristics
(vs. subject
device) | (Subject Device) | A notable difference, when compared to the
subject device, is the lack of microthreads.
Microthreads on the subject device will only
slightly increase the surface area of the bone-
implant contact. The very minute topographic | A notable difference, when compared to the
subject device, is the lack of microthreads.
Microthreads on the subject device will only
slightly increase the surface area of the bone-
implant contact. The very minute topographic |
| | features and small increase in surface area on
the subject device creates an insignificant
deviation from the predicate design, thus does
not render the subject device NSE.
Another notable difference when compared to
the subject device, are the length of the flutes.
Although the subject device exhibit longer flute
lengths, flutes on both predicate device and the
Implanova subject devices are designed for
self-tapping (self-threading) and are
functionally similar. This difference does not
make the subject device NSE because more
tapping edges simply ease the tapping
processes but functions the same. | features and small increase in surface area on
the subject device creates an insignificant
deviation from the predicate design, thus does
not render the subject device NSE.
Another notable difference when compared to
the subject device, are the length of the flutes.
Although the subject device exhibit longer
flute lengths, flutes on both predicate
device and the Implanova subject devices are
designed for self-tapping (self-threading) and
are functionally similar. This difference does
not make the subject device NSE because
more tapping edges simply ease the tapping
processes but functions the same. | |
| | Another notable difference between subject
device and the predicate is the twist direction
of the vertical flutes. The subject device's
vertical flute is a very minor left hand twist
(18mm pitch). Majority of implants in market
including the predicate device have a straight
vertical flute. The function of flutes in subject
And predicate device is to provide cutting
edges for the tapping feature of the fixture as
well as to provide clearances for the
consolidation of swarf material (bone debris).
The minor left hand helical twist of the subject
device only slightly increases the sharpness of
the edges of the implant's tapping features and
passively guides the swarf materials to
consolidate in the provided flute clearances.
Thus, the slight helical twist of the subject
device should not render the device NSE. | Another notable difference between subject
device and the predicate is the twist direction
of the vertical flutes. The subject device's
vertical flute is a very minor left hand twist
(18mm pitch). Majority of implants in market
including the predicate device have a straight
vertical flute. The function of flutes in subject
And predicate device is to provide cutting
edges for the tapping feature of the fixture as
well as to provide clearances for the
consolidation of swarf material (bone debris).
The minor left hand helical twist of the subject
device only slightly increases the sharpness of
the edges of the implant's tapping features and
passively guides the swarf materials to
consolidate in the provided flute clearances.
Thus, the slight helical twist of the subject
device should not render the device NSE. | |
| | Another notable difference between subject
device and the predicate is the partial surface
treatment of the subject device. While the
surfaces of the predicate devices are modified
throughout the implant body, the subject device | Another notable difference between subject
device and the predicate is the partial surface
treatment of the subject device. While the
surfaces of the predicate devices are modified
throughout the implant body, the subject | |
| | | | |
| | is modified throughout the body except the
apical 5 mm. The subject fixture's untreated
apical area maintains the sharpness of the
tapping edges for cutting (tapping) of the bone.
Since surface treatment is not a requirement for
osseointegration, this difference does not make
the subject device NSE. (All original
Branemark implants were machine finished and
did not have any surface treatments) | device is modified throughout the body except
the apical 5 mm. The subject fixture's
untreated apical area maintains the sharpness
of the tapping edges for cutting (tapping) of
the bone. Since surface treatment is not a
requirement for osseointegration, this
difference does not make the subject device
NSE. (All original Branemark implants were
machine finished and did not have any surface
treatments).
Although the material used in the surface
modification of the subject device is not the
same with the predicate device, the chemical
analysis data provided in the section "7.8
Surface Treatment Method" of this
submission" supports that the
blast media used for the subject device does
not alter surface chemical compositions. | |
13
14
15
Comparative Table for Bone Level Straight Abutment
| Subject Device | Predicate Device | |
|---|---|---|
| 510(K) Number | - | K101005, K072624 |
| Device Name | Implanova® Bone Level Straight Abutments | Astra Tech Implant System, New Components |
| Manufacturer | Dental Evolutions Inc. | Astra Tech AB |
| Connection type | Screw Retained | Screw Retained |
| Design & Size Range | Platform Diameter: 4.2mm, 4.8mm, 6.5 mm | |
| Post Height: 5.7 mm | ||
| Platform Height: 2 mm | ||
| Thread Type: M1.6 | Platform Diameter: 4.0mm, 5.0mm, 6.0mm | |
| Post Height: 5.0mm, 5.5mm | ||
| Platform Height: 0.5mm, 1.0mm, 2.5mm, 4.0mm | ||
| Thread Type: M1.6 | ||
| Intended Use | Intended use is identical to the predicate device | Cement retained restoration |
| Design Characteristics | - Straight abutment |
- Non-indexed seating
- Screws directly into implant assembly
- Tapered abutment-to-crown cementing areas
- .05" Hexagonal socket for carrying, seating and retrieval | - Straight abutment
- Non-indexed seating
- Screws directly into implant assembly
- Tapered base for hermetic/bacterial seal with implant during assembly
- Tapered abutment-to-crown cementing areas
- .05" Hexagonal socket for carrying, seating and retrieval |
16
| Material Composition | Titanium Alloy grade 23 (Ti6Al4V ELI) | CP Titanium grade 4 |
|---|---|---|
| Surface Treatment | No | No |
| Sterile | No | No |
| Sterilization Method | N/A | N/A |
| Differences in | ||
| Technological | ||
| Characteristics (vs. subject | ||
| device) | (Subject Device) | There are no major design difference between this abutment and |
| the Implanova subject device. Although the material composition | ||
| of this device is Grade 4 Titanium while the subject device is | ||
| Grade 23 Titanium, both materials used in the predicate and | ||
| subject device are remarkably similar in performance, and both | ||
| grade 4 and grade 23 titanium are commonly used for | ||
| implantation. |
Comparative Table for Bone Level Angled Abutment
| Subject Device | Predicate Device | |
|---|---|---|
| 510(K) Number | - | K101005, K072624 |
| Device Name | Implanova® Angled Bone Level Abutment | Astra Tech Implant System, New Components |
| Angled TiDesign Abutment | ||
| Manufacturer | Dental Evolutions Inc. | Astra Tech AB |
| Connection type | Screw Retained/ Hexagonal seating index | Screw Retained/ Hexagonal seating index |
| Design & Size Range | Platform Diameter: 4.2mm, 4.8mm, 6.5 mm | |
| Post Angle:15° and 20° | ||
| Platform Height: 2 mm | Platform Diameter: 4.0 mm | |
| Post Angle:15° and 20° | ||
| Platform Height: 2.4 mm | ||
| Intended Use | Intended use is identical to the predicate device | Cement retained restoration |
| Design Characteristics | - Angled abutment |
- Hexagonal seating index
- Tapered base for hermetic/bacterial seal with implant during assembly
- Tapered abutment-to-crown cementing areas | - Angled abutment
- Hexagonal seating index
- Tapered base for hermetic/bacterial seal with implant during assembly
- Tapered abutment-to-crown cementing areas |
| Material Composition | Titanium Alloy grade 23 (Ti6Al4V ELI) | CP Titanium grade 4 |
| Surface Treatment | No | No |
| Sterile | No | No |
| Sterilization Method | N/A
(Subject Device) | N/A |
| Differences in
Technological
Characteristics (vs.
subject device) | | There are no major design difference between this abutment and
the Implanova subject device. Although the material composition
of this device is Grade 4 Titanium while the subject device is
Grade 23 Titanium, both materials used in the predicate and
subject device are remarkably similar in performance, and both
grade 4 and grade 23 titanium are commonly used for
implantation. |
17
8. Non-Clinical Testing
The following testing was performed and the test results supported that the subject device is substantially equivalent to the predicate devices and it is in conformance with the FDA guidance document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments.
- · Fatigue Testing according to ISO 14801
- 3"d Party Compatibility
- · Sterilization Validationaccording to ISO 11137-1, ISO 11137-2, ISO11737-1, ISO11737-2, ISO 17665-1 and ISO 17665-2
- · Shelf-life Validation according to ASTM F1980, ISO 11607-1, ISO 11607-2, ASTM F88, and ASTM F 1929
- · Cytotoxicity Testing according to ISO 10993-5
- SEM/EDS Chemical Surface Analysis
9. Conclusion
Based on the similarities, we conclude that the Implanova® system is substantially equivalent to its predicate devices.