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.

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.

AI/ML Overview

This document is a 510(k) Pre-market Notification for the Implanova® Dental Implant System. It aims to demonstrate substantial equivalence to legally marketed predicate devices. The document does not describe acceptance criteria or a study proving the device meets specific performance criteria with numerical results for the device itself (Implanova®). Instead, it relies on demonstrating substantial equivalence to predicate devices through comparisons of design, materials, intended use, and non-clinical testing for safety and appropriate material and manufacturing characteristics.

Here’s a breakdown of the information that is available within the provided text, and what is not present based on your request:

1. A table of acceptance criteria and the reported device performance:

This information is not explicitly provided in the format requested. The document asserts that "the fatiguetest result of the subject device supports that the subject device is substantially equivalent to the predicate devices" (Pages 11 and 12), and that non-clinical testing "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" (Page 17). However, the specific acceptance criteria for these tests (e.g., minimum fatigue strength in MPa or N) and the numerical results achieved by the Implanova® device are not listed. The document focuses on similarity to predicate devices rather than meeting discrete performance metrics presented in a table.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided. The document lists types of non-clinical tests but does not specify the sample sizes used for these tests, nor the data provenance. These are typically details found in the full test reports, which are not included here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable/provided. The document describes non-clinical, laboratory-based testing (e.g., fatigue, sterilization, cytotoxicity, SEM/EDS) rather than clinical studies requiring expert review of data for ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable/provided. As above, this pertains to clinical study design and human interpretation of results, which is not described here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable/provided. This document describes an endosseous dental implant system, which is a physical medical device, not an AI-assisted diagnostic or decision support system that would involve human readers or AI improvement metrics.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable/provided. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

This information is not applicable/provided in the context of clinical "ground truth." The ground truth for the non-clinical tests would be the established scientific methods and standards (e.g., ISO 14801 for fatigue testing, ISO 11137-1 for sterilization).

8. The sample size for the training set:

This information is not applicable/provided. As this is a physical medical device, there is no "training set" in the context of machine learning or AI models.

9. How the ground truth for the training set was established:

This information is not applicable/provided. As above, there is no "training set."

Summary of available information related to performance and predicate devices:

The document primarily demonstrates substantial equivalence by comparing the Implanova® device to several predicate devices.

Key similarities highlighted for Implanova® Bone Level Implants (compared to BioHorizons Tapered Internal Plus, BioHorizons Internal Implants, U fit Dental Implant System):

Intended Use: Same intended use (endosseous implantation in mandible and maxilla for artificial root structure, single/multiple missing teeth, support prosthesis, immediate loading when primary stability achieved).
Operating Principle: Same.
Basic Design: Incorporates same basic design (self-tapping, bone-level type implant, micro-threaded implant collar, tapered implant body).
Material: Titanium Alloy grade 23 (Ti6Al4V ELI).
Surface Treatment: Resorbable Blast Texture Media (calcium phosphate), partial surface treatment.
Sterile: Yes.
Sterilization Method: Gamma Radiation.
Size Range: Similar (e.g., Diameter: 3.5mm, 4.5mm, 5.5mm; Length: 8mm, 10mm, 12mm, 14mm).

Key differences and justification for substantial equivalence despite differences:

Micro-machined grooves vs. Micro threads: Laser-Lok® micro-machined grooves on predicates vs. micro threads on Implanova®. Justification: "functionally identical" as osteocytes cannot differentiate microscopic differences for osseointegration.
Flute Lengths: Implanova® has longer flute lengths. Justification: "more tapping edges simply ease the tapping processes but functions the same."
Twist Direction of Vertical Flutes: Implanova® has a minor left-hand twist (18mm pitch) vs. straight or slight right-hand twist on predicates. Justification: "only slightly increases the sharpness of the edges... and passively guides the swarf materials to consolidate... should not render the device NSE."
Partial Surface Treatment: Implanova® has partial surface treatment (apical 5mm untreated) vs. modified throughout the implant body on predicates. Justification: Untreated apical area maintains sharpness for cutting bone; surface treatment is not a requirement for osseointegration.
Fatigue Test Result: The document states that "the fatiguetest result of the subject device supports that the subject device is substantially equivalent to the predicate devices." (No numerical results are provided in the excerpt).

Key similarities highlighted for Implanova® All-in-One 3.0mm Implants (compared to Zimmer One-Piece Implant System, NobelDirect 3.0):

Intended Use: Similar indications for support and retention of fixed single tooth and fixed partial dentures in specific mandibular/maxillary incisor regions, with immediate loading when good primary stability is achieved and appropriate occlusal loading.
Design & Size: 3.0mm diameter.
Connection Type: N/A (one-piece design).
Basic Design: Self-tapping, tissue-level type implant, micro-threaded implant collar, tapered implant body.
Material: Titanium Alloy grade 23 (Ti6Al4V ELI) (NobelDirect uses CP Titanium grade 4).
Surface Treatment: Resorbable Blast Texture Media (calcium phosphate), partial surface treatment (Zimmer uses Hydroxyapatite blast media, NobelDirect uses TiUnite).
Sterile: Yes.
Sterilization Method: Gamma Radiation.

Key differences and justification for substantial equivalence despite differences:

Microthreads: Implanova® has microthreads vs. lack of microthreads on predicates. Justification: "only slightly increase the surface area... insignificant deviation... does not render the subject device NSE."
Flute Lengths, Twist Direction, Partial Surface Treatment: Similar justifications to the bone-level implants regarding these differences.
Surface Treatment Material: Implanova® uses calcium phosphate blast media; predicates use Hydroxyapatite or TiUnite. Justification: "chemical analysis data... supports that the blast media used for the subject device does not alter surface chemical compositions."

Non-Clinical Testing Performed (Page 17):

Fatigue Testing (ISO 14801)
3rd Party Compatibility
Sterilization Validation (ISO 11137-1, ISO 11137-2, ISO11737-1, ISO11737-2, ISO 17665-1 and ISO 17665-2)
Shelf-life Validation (ASTM F1980, ISO 11607-1, ISO 11607-2, ASTM F88, and ASTM F 1929)
Cytotoxicity Testing (ISO 10993-5)
SEM/EDS Chemical Surface Analysis

These tests are stated to have "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."

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K150040

Device Name

Implanova®

Indications for Use (Describe)

Implanova® Bone Level to Astra Tech Compatibility List
Component Type	Part #	Device Name	Manufacturer	Compatible Implanova® BoneLevel 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.

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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

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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

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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

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:

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,

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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® BoneLevel 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.

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	Subject Device	Primary Predicate Device	Reference Predicate Device1	Reference Predicate Device2
510(K) Number		K121787	K073268	K132956
Device Name	Implanova® Bone LevelImplant	BioHorizons Tapered Internal PlusImplants	BioHorizons Internal Implants	U fit Dental Implant System
Manufacturer	Dental Evolutions Inc.	BioHorizons Implant Systems, Inc.	BioHorizons Implant Systems,Inc.	T Strong Inc.
ConnectionType	Internal Hexagon	Internal Hexagon	Internal Hexagon	Internal Hexagon
Size Range	Diameter: 3.5mm, 4.5mm,5.5mmLength: 8mm (excluding 3.5mmdiameter), 10mm, 12mm, 14mm(excluding 5.5mm diameter)	Diameter: 3.8mm, 4.6mm, 5.8mmLength: 7.5mm (excluding 3.8mmdiameter), 9mm, 10.5mm, 12mm,15mm	Diameter: 3.5mm, 4.0mm,5.0mm, 6.0mmLength: 9mm, 10.5mm, 12mm,15mm	Diameter: 3.8mm, 3.9mm,4.0mm, 4.2mm, 4.5mm, 5.0mm,5.5mm, 6.0mm, 7.0mmLength: 7mm, 8.5mm, 10mm,11.5mm, 13mm, 14.5mm
Indications forUse	The Implanova® Bone Levelimplants are intended forendosseous implantation in themandible and maxilla for use asan artificial root structure.These root form implants can beused to replace single ormultiple missing teeth and/or tosupport a fixed or removableprosthesis in partially orcompletely edentulous upperand lower dental arches. Alldevices in the Implanova®Bone Level system, includingimplant fixtures, abutments,healing caps, cover screws, andretention screws are intendedfor use by prescription only.Implanova® Bone Levelimplants are intended forimmediate loading when goodprimary stability is achievedand with appropriate occlusalloading.	BioHorizons Tapered Internal PlusImplants are intended for use in themandible or maxilla as an artificialroot structure for single toothreplacement or for fixed bridgework and dental retention.Theimplants may be restoredimmediately (1) withatemporaryprosthesis that is not infunctional occlusion or (2) whensplinted together for multipletoothreplacement or when stabilizedwith an overdenture supported bymultiple implants.	BioHorizons Internal Implants areintended for use in the mandible ormaxilla as an artificial rootstructure for single toothreplacement or for fixedbridgework and dental retention.BioHorizons Internal Implantsmay be restored immediately (1)with a temporary prosthesis that isnot in functional occlusion, or (2)when splinted together formultiple tooth replacement, orwhen stabilized with anoverdenture supported by multipleimplants.	The U fit Dental ImplantSystem is indicated for use inpartially or fully edentulousmandibles and maxillae, insupport of single or multiple-unit restorations including;cemented retained, screwretained, or overdenturerestorations, and terminal orintermediate abutment supportfor fixed bridgework. The U fitDental Implant System is forsingle and two stage surgicalprocedures. It is intended fordelayed loading.

Comparative Table for Bone Level Implant

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	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

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	- Partial surface treatment
Sterile	Yes	Yes	Yes	Yes
SterilizationMethod	Gamma Radiation	Gamma Radiation	Gamma Radiation	Gamma Radiation
Differences inTechnologicalCharacteristics(vs. subjectdevice)	(Subject Device)	A notable difference, whencompared to the subject device, isthe Laser-Lok® micro-machinedgrooves on this predicate deviceand the micro threads on thecervical area of subject device. TheLaser-Lok® feature on thepredicate device and themicrothreads on the subject deviceare functionally identical. They donot render the device NSE becausethe osteocytes cannot differentiatethe microscopic differences intopography in osseointegration.Another notable difference whencompared to the subject device, arethe length of the flutes. Althoughthe subject device exhibit longerflute lengths, flutes on bothBioHorizon Tapered InternalPlus and the Implanova subjectdevices are designed for self-tapping (self-threading) and arefunctionally similar. Thisdifference does not make thesubject device NSE because moretapping edges simply ease thetapping processes but functions thesame.Another notable differencebetween subject device and thepredicate is the twist direction ofthe vertical flutes. The subject	A notable difference, whencompared to the subject device, isthe Laser-Lok® micro-machinedgrooves on this predicate deviceand the micro threads on thecervical area of subject device.They do not render the deviceNSE because the osteocytescannot differentiate themicroscopic differences intopography in osseointegration.Another notable difference whencompared to the subject device,are the length of the flutes.Although the subject deviceexhibit longer flute lengths, fluteson both BioHorizon InternalImplants and the Implanovasubject devices are designed forself-tapping (self-threading) andare functionally similar. Thisdifference does not make thesubject device NSE because moretapping edges simply ease thetapping processes but functionsthe same.Another notable differencebetween subject device and thepredicate is the twist direction ofthe vertical flutes. The subjectdevice's vertical flute is a veryminor left hand twist (18mmpitch). Majority of implants in	A notable difference betweensubject device and the predicateis the twist direction of thevertical flutes. The subjectdevice's vertical flute is a veryminor left hand twist (18mmpitch), while the predicatedevice possesses a slight righthand twist. The function offlutes in subject andpredicatedevice is to provide cuttingedges for the tapping feature ofthe fixture as well as to provideclearances for the consolidationof swarf material (bone debris).The minor left hand helical twistof the subject device onlyslightly increases the sharpnessof the edges of the implant'stapping features and passivelyguides the swarf materials toconsolidate in the provided fluteclearances. Thus, the slighthelical twist of the subjectdevice should not render thedevice NSE.Another notable differencebetween subject device and thepredicate is the partial surfacetreatment of the subject device.While the surfaces ofthe predicate devices aremodified throughout the implantbody, the subject device is

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device's vertical flute is a veryminor left hand twist (18mmpitch). Majority of implants inmarket including the predicatedevice have a straight verticalflute. The function of flutes insubject andpredicate device is toprovide cutting edges for thetapping feature of the fixture. Theminor left hand helical twist of thesubject device only slightlyincreases the sharpness of theedges of the implant's tappingfeatures and passively guides theswarf materials to consolidate inthe provided flute clearances.	market including the predicatedevice have a straight verticalflute. The function of flutes insubject andpredicate device is toprovide cutting edges for thetapping feature of the fixture. Theminor left hand helical twist of thesubject device only slightlyincreases the sharpness of theedges of the implant's tappingfeatures and passively guides theswarf materials to consolidate intheprovided flute clearances. Thus,the slight helical twist of thesubject device should not renderthe device NSE.	modified throughout the bodyexcept the apical 5 mm. Bothtreated areas identicallyfunctions in order to increasesurface area forosseointegration. The subjectfixture's untreated apical areamaintains the sharpness of thetapping edges for cutting(tapping) of the bone. Sincesurface treatment is not arequirement forosseointegration, this differencedoes not make the subjectdevice NSE. (All originalBranemark implants weremachine finished and did nothave any surface treatments)
Thus, the slight helical twist of thesubject device should not renderthe device NSE.	Another notable differencebetween subject device and thepredicate is the partial surfacetreatment of the subject device.While the surfaces ofthe predicate devices are modifiedthroughout the implant body, thesubject device is modifiedthroughout the body except theapical 5 mm. The subject fixture'suntreated apical area maintainsthe sharpness of the tapping edgesfor cutting (tapping) of the bone.Since surface treatment is not arequirement for osseointegration,this difference does not make thesubject device NSE. (All originalBranemark implants weremachine finished and did not haveany surface treatments)	Despite these differences indesign, the fatiguetest result ofthe subject device supports thatthe subject device issubstantially equivalent to thepredicate devices.
Another notable differencebetween subject device and thepredicate is the partial surfacetreatment of the subject device.While the surfaces ofthe BioHorizons Tapered InternalPlus implants are modifiedthroughout the implant body, thesubject device is modifiedthroughout the body except theapical 5 mm. The subject fixture'suntreated apical area maintains thesharpness of the tapping edges forcutting (tapping) of the bone.Since surface treatment is not arequirement for osseointegration,this difference does not make thesubject device NSE. (All originalBranemark implants were machine

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finished and did not have anysurface treatments)Despite these differences in design,the fatiguetest result of the subjectdevice supports that the subjectdevice is substantially equivalentto the predicate devices.	design, the fatiguetest result of thesubject device supports that thesubject device is substantiallyequivalent to the predicatedevices.
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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
ConnectionType	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 implantsare intended for endosseous implantationin the mandible and maxilla for use as anartificial root structure. These root formimplants can be used to replace single ormultiple missing teeth and/or to supporta fixed or removable prosthesis inpartially or completely edentulous upperand lower dental arches. All devices inthe Implanova® Bone Level system,including implant fixtures, abutments,healing caps, cover screws, and retentionscrews are intended for use byprescription only. Implanova® BoneLevel implants are intended forimmediate loading when good primarystability is achieved and with appropriateocclusal loading.Implanova® All-in-One 3.0mm implants	Zimmer® One-Piece 3.7mm implants areindicated for the support and retention of fixedsingle tooth and fixed partial denturerestorations in the premolar, cuspid, and incisorregions of partially edentulous jaws. Zimmer®One-Piece 3.7mm implants may be loadedimmediately in the anterior mandibular arch iffour are splinted together with a bar. TheZimmer® 3.7mm One-Piece implant may beimmediately restored with a temporaryprosthesis that is not in functional occlusion.Zimmer® One-Piece 3.0mm implants areindicated for the support and retention of fixedsingle tooth and fixed partial denturerestorations in the mandibular central andlateral incisor and maxillary lateral incisorregions of partially edentulous jaws. TheZimmer® One-Piece 3.0mm implant must besplinted if two or more are used adjacent to	The Nobel Direct 3.0mm implant is indicatedfor use in the treatment of missing maxillarylateral incisors or the mandibular central andlateral incisors to support prosthetic devicessuch as artificial teeth, in order to restorechewing function in partially edentulouspatients. The Nobel Direct 3.0 Implants maybe put into immediate function provided thatstability requirements detailed in the manualare satisfied. Mandible central and lateralincisors must be splinted if using two or more3.0mm implants adjacent to one another.

	are indicated for the support andretention of fixed single tooth and fixedpartial denture restorations in themandibular central and lateral incisorand maxillary lateral incisor regions ofpartially edentulous jaws. TheImplanova® All-in-One 3.0mm implantmust be splinted if two or more are usedadjacent to each other. Implanova® All-in-One 3.0mm implant are intended forimmediate loading when good primarystability is achieved and with appropriateocclusal loading.All Implanova® Bone Level implantfixtures are compatible with the straighttype restorative components listed in thetable below, including straight typeabutments, straight type abutment screwsand straight type temporary abutmentsthat are intended to be on Astra Tech'sOsseoSpeed™ TX 3.5S andOsseoSpeed™ TX 4.0S implant fixtures.	each other. The Zimmer® One-Piece 3.0mmimplant may be immediately restored with atemporary prosthesis that is not in functionalocclusion.
DesignCharacteristics	- 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
MaterialComposition	Titanium Alloy grade 23 (Ti6Al4V ELI)	Titanium Alloy grade 23 (Ti6Al4V ELI)	CP Titanium grade 4
SurfaceTreatment	- 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
SterilizationMethod	Gamma Radiation	Gamma Radiation	Gamma Radiation
Differences inTechnologicalCharacteristics(vs. subjectdevice)	(Subject Device)	A notable difference, when compared to thesubject device, is the lack of microthreads.Microthreads on the subject device will onlyslightly increase the surface area of the bone-implant contact. The very minute topographic	A notable difference, when compared to thesubject device, is the lack of microthreads.Microthreads on the subject device will onlyslightly increase the surface area of the bone-implant contact. The very minute topographic
	features and small increase in surface area onthe subject device creates an insignificantdeviation from the predicate design, thus doesnot render the subject device NSE.Another notable difference when compared tothe subject device, are the length of the flutes.Although the subject device exhibit longer flutelengths, flutes on both predicate device and theImplanova subject devices are designed forself-tapping (self-threading) and arefunctionally similar. This difference does notmake the subject device NSE because moretapping edges simply ease the tappingprocesses but functions the same.	features and small increase in surface area onthe subject device creates an insignificantdeviation from the predicate design, thus doesnot render the subject device NSE.Another notable difference when compared tothe subject device, are the length of the flutes.Although the subject device exhibit longerflute lengths, flutes on both predicatedevice and the Implanova subject devices aredesigned for self-tapping (self-threading) andare functionally similar. This difference doesnot make the subject device NSE becausemore tapping edges simply ease the tappingprocesses but functions the same.
	Another notable difference between subjectdevice and the predicate is the twist directionof the vertical flutes. The subject device'svertical flute is a very minor left hand twist(18mm pitch). Majority of implants in marketincluding the predicate device have a straightvertical flute. The function of flutes in subjectAnd predicate device is to provide cuttingedges for the tapping feature of the fixture aswell as to provide clearances for theconsolidation of swarf material (bone debris).The minor left hand helical twist of the subjectdevice only slightly increases the sharpness ofthe edges of the implant's tapping features andpassively guides the swarf materials toconsolidate in the provided flute clearances.Thus, the slight helical twist of the subjectdevice should not render the device NSE.	Another notable difference between subjectdevice and the predicate is the twist directionof the vertical flutes. The subject device'svertical flute is a very minor left hand twist(18mm pitch). Majority of implants in marketincluding the predicate device have a straightvertical flute. The function of flutes in subjectAnd predicate device is to provide cuttingedges for the tapping feature of the fixture aswell as to provide clearances for theconsolidation of swarf material (bone debris).The minor left hand helical twist of the subjectdevice only slightly increases the sharpness ofthe edges of the implant's tapping features andpassively guides the swarf materials toconsolidate in the provided flute clearances.Thus, the slight helical twist of the subjectdevice should not render the device NSE.
	Another notable difference between subjectdevice and the predicate is the partial surfacetreatment of the subject device. While thesurfaces of the predicate devices are modifiedthroughout the implant body, the subject device	Another notable difference between subjectdevice and the predicate is the partial surfacetreatment of the subject device. While thesurfaces of the predicate devices are modifiedthroughout the implant body, the subject

	is modified throughout the body except theapical 5 mm. The subject fixture's untreatedapical area maintains the sharpness of thetapping edges for cutting (tapping) of the bone.Since surface treatment is not a requirement forosseointegration, this difference does not makethe subject device NSE. (All originalBranemark implants were machine finished anddid not have any surface treatments)	device is modified throughout the body exceptthe apical 5 mm. The subject fixture'suntreated apical area maintains the sharpnessof the tapping edges for cutting (tapping) ofthe bone. Since surface treatment is not arequirement for osseointegration, thisdifference does not make the subject deviceNSE. (All original Branemark implants weremachine finished and did not have any surfacetreatments).Although the material used in the surfacemodification of the subject device is not thesame with the predicate device, the chemicalanalysis data provided in the section "7.8Surface Treatment Method" of thissubmission" supports that theblast media used for the subject device doesnot alter surface chemical compositions.

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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 mmPost Height: 5.7 mmPlatform Height: 2 mmThread Type: M1.6	Platform Diameter: 4.0mm, 5.0mm, 6.0mmPost Height: 5.0mm, 5.5mmPlatform Height: 0.5mm, 1.0mm, 2.5mm, 4.0mmThread 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

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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 inTechnologicalCharacteristics (vs. subjectdevice)	(Subject Device)	There are no major design difference between this abutment andthe Implanova subject device. Although the material compositionof this device is Grade 4 Titanium while the subject device isGrade 23 Titanium, both materials used in the predicate andsubject device are remarkably similar in performance, and bothgrade 4 and grade 23 titanium are commonly used forimplantation.

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 ComponentsAngled 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 mmPost Angle:15° and 20°Platform Height: 2 mm	Platform Diameter: 4.0 mmPost 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 inTechnologicalCharacteristics (vs.subject device)		There are no major design difference between this abutment andthe Implanova subject device. Although the material compositionof this device is Grade 4 Titanium while the subject device isGrade 23 Titanium, both materials used in the predicate andsubject device are remarkably similar in performance, and bothgrade 4 and grade 23 titanium are commonly used forimplantation.

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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.

Regulation Number and Section

§ 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.