OsseOne Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patients and chewing function. Osse one implants are intended for single or multiple unit restorations on splinted applications. OsseoPlus and OsseoLock are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period. OsseoLock 3.3 implants are intended to replace a lateral incisor in the maxilla and/or a central incisor in the mandible. Mandibular central and lateral incisors must be splinted if using two or more 3.3 implants adjacent to one another.

Device Description

OsseOne Dental Implant System is an internal hex implant system with two models of implant, OsseoLock which is a cylindrical implant and OsseoPlus which is a spiral implant. OsseoLock comes in 3.3, 3.7, 4.2, 5.0, and 6.0 diameter. OsseoPlus comes in diameters of 3.5, 3.75, 4.2, 5.0 and 6.0. The implants come in lengths of 8, 10, 11.5, 13 and 16. OsseoLock 5.0 and 6.0 diameter implants do not come in 16mm length. Both straight and angled abutments are available. The implants have a grit blasted and acid etched surface. Standard abutments, standard narrow abutments, standard shoulder abutments, standard wide shoulder abutments, multi-unit abutments, denture lock abutments, overdenture abutments, angled overdenture abutments, ball attachments, healing caps (3.8, 4.6, 5.5, and 6.3 mm diameter), UCLA in 4.5mm diameter and standard 15° and 25° abutments are included in the system.

AI/ML Overview

The provided text describes the OsseOne Dental Implant System and its equivalence to a predicate device, the SpiralTech Dental Implant System. It does not contain information about an AI/ML-driven device or study parameters related to AI/ML device performance. Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI/ML device.

The document discusses the following types of testing for the OsseOne Dental Implant System:

Dynamic fatigue testing (ISO 14801): To determine abutment strength.
Surface analysis: According to FDA guidance.
Sterilization validation: For implants (ISO 11137-1 and ISO 11137-2) and abutments (ISO 17665-1 and ISO 17665-2).
Package integrity testing and accelerated aging: According to ASTM F1929-12, ASTM F 1980-07(2011), ASTM D 4332-13, ASTM D 999-08, ASTM D4169-09, ASTM D5276-98(2009), and ASTM F 3039-13.
Materials testing: ASTM F136.
Endotoxin testing: USP 161.
Cytotoxicity testing: ISO 10993-5.

The study presented is a substantial equivalence comparison study where the OsseOne Dental Implant System is compared to the SpiralTech Dental Implant System.

Acceptance Criteria and Reported Device Performance (Table):

Acceptance Criterion (Implicit from comparison)	Reported Device Performance (OsseOne Dental Implant System)
Indications for Use: Identical to predicate device.	Identical to SpiralTech Dental Implant System.
Materials: Same as predicate device.	Same materials as SpiralTech Dental Implant System. Meets ASTM F136.
Design: Similar to predicate device (minor dimensional differences acceptable).	Abutment designs are very similar, some practically identical. Minor dimensional changes do not change substantial equivalence.
Fatigue Performance (ISO 14801): Run out limits comparable/higher than other implant systems.	Run out limits for both designs (OsseoLock and OsseoPlus) are the same or higher than other implant systems.
Cytotoxicity (ISO 10993-5): Non-cytotoxic.	Cytotoxicity testing conducted; surfaces are not cytotoxic.
Sterilization Efficacy (ISO 11137, ISO 17665): Validated.	Implants validated by gamma irradiation. Abutment steam sterilization validated.
Package Integrity & Shelf Life (ASTM standards): Validated.	Package integrity testing and accelerated aging conducted.
Endotoxins (USP 161): Complies.	Endotoxin testing conducted.

Missing Information (as per your request for AI/ML devices):

The provided text does not contain any of the following details, as the device is not an AI/ML device:

Sample size used for the test set and data provenance (e.g. country of origin of the data, retrospective or prospective)
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Adjudication method (e.g. 2+1, 3+1, none) for the test set
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The sample size for the training set
How the ground truth for the training set was established

Summary

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February 15, 2019

Synoross DBA OsseOne % Angela Blackwell Senior Consultant Blackwell Device Consulting P.O. Box 718 Gresham, Oregon 97030-0172

Re: K182293

Trade/Device Name: OsseOne Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: January 8, 2019 Received: January 16, 2019

Dear Angela Blackwell:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Andrew I. Steen -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182293

Device Name

OsseOne Dental Implant System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510k Summary February 15, 2019 OsseOne Dental Implant System K182293

Name and address: OsseOne 330 N Central Avenue Glendale, CA 91203 Contact Person: Gene Shapiro Phone Number: 818-242-3763 Name of device: OsseOne Dental Implant System Classification Name: Endosseous dental implants CFR: 21 CFR 872.3640 Primary Product Code: DZE Secondary Product Code: NHA

Device Description: OsseOne Dental Implant System is an internal hex implant system with two models of implant, OsseoLock which is a cylindrical implant and OsseoPlus which is a spiral implant. OsseoLock comes in 3.3, 3.7, 4.2, 5.0, and 6.0 diameter. OsseoPlus comes in diameters of 3.5, 3.75, 4.2, 5.0 and 6.0. The implants come in lengths of 8, 10, 11.5, 13 and 16. OsseoLock 5.0 and 6.0 diameter implants do not come in 16mm length. Both straight and angled abutments are available.

The implants have a grit blasted and acid etched surface. Standard abutments, standard narrow abutments, standard shoulder abutments, standard wide shoulder abutments, multi-unit abutments, denture lock abutments, overdenture abutments, angled overdenture abutments, ball attachments, healing caps (3.8, 4.6, 5.5, and 6.3 mm diameter), UCLA in 4.5mm diameter and standard 15° and 25° abutments are included in the system.

Indications for Use: OsseOne Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient's esthetics and chewing function. OsseOne implants are intended for single or multiple unit restorations on splinted or non-splinted applications. OsseoPlus and OsseoLock are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period. OsseoLock 3.3 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. Mandibular central and lateral incisors must be splinted if using two or more 3.3 implants adjacent to one another.

Testing Summary: Dynamic fatigue testing according to ISO 14801 was conducted to determine the abutments are strong enough for their intended use. Both designs exhibited run out limits about the same or higher than other implant systems. Surface analysis according to the FDA guidance document was done. Sterilization validation was conducted on the implants according to ISO 11137-1 and ISO 11137-2. Abutment steam sterilization was done according to ISO 17665-1 and ISO 17665-2.

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Package integrity testing and accelerated aging were conducted according to standards ASTM F1929-12, ASTM F 1980-07(2011), ASTM D 4332-13, ASTM D 999-08, ASTM D4169-09, ASTM D5276-98(2009) and ASTM F 3039-13. Materials used in the product meet ASTM F136. Endotoxin testing according to USP 161 was conducted. Cytotoxicity according to ISO 10993-5 was conducted on implants and abutments ready for final packaging.

Primary Predicate Device: SpiralTech Dental Implant System Ultimate Hex and Esi Hex K170372 Reference Devices: Zest Dental Solutions K083324 Locator Abutments and Cortex K090709

Substantial Equivalence:

OsseOne Dental Implant System is substantially equivalent to SpiralTech Dental Implant System in indications for use, materials, design, and fatigue performance. The indications for use are identical. The materials are the same and both systems have cytotoxicity testing which meets ISO 10993-5 to show the surfaces of the devices are not cytotoxic. The abutment designs are all very similar and in some cases practically identical. Any differences are minor ones of slight dimensional changes so do not change the substantial equivalence. Both systems have fatigue test according to ISO 14801 which cover all the models that demonstrate the systems are sufficiently strong for their common intended use. Both systems have gamma irradiation and endotoxin testing for the implants and steam sterilization validation for the abutments. Shelf life and package testing was conducted on both systems.

	OsseOne Dental Implant System	SpiralTech Dental Implant System K170372Ultimate Hex and ESi Hex
Implant System Comparison TableOsseoLockOsseoPlus	OsseoLockOsseoPlus
Diameter of ImplantsOsseoLockOsseoPlus	3.3, 3.75, 4.2, 5.0, 6.03.5, 3.75, 4.2, 5.0, 6.0	ESi Hex 3.3, 3.5, 4.3, 5.0, 6.0Ultimate Hex 3.3, 3.5, 4.3, 5.0, 6.0
Implant Lengths	8, 10, 11.5, 13, 16 (OsseoLock 5.0 and 6.0 not in 16mm)	8, 10, 11, 13, 15
Surface Treatment	SLA	SLA or RBM
Sterilization of Implants	Provided sterile by gamma irradiation	Provided sterile by gamma irradiation
Sterilization of abutments	Provided non-sterile with instructions for user to sterilize them	Provided non-sterile with instructions for user to sterilize them
Connection	Internal Hex	Internal Hex
Spiral Implant Design	OsseoPlus	Ultimate Hex
Cylindrical Implant Design	OsseoLock	Esi Hex
ISO 14801 Fatigue Test	Run out limits for both designs are the same or higher than those of other implant systems	Run out limits are comparable to other implant systems.
Indications for Use	OsseOne Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to	The Spiraltech Dental Implants are endosseous implants intended to be surgically placed in the upper or lower jaw arches to

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	OsseOne DentalImplant System	SpiralTech DentalImplant System orNoted ReferenceDevice
Cover screw	Cover screw	Cover screw
Multi-Unit Abutments*	Multi-unit abutments inheights of 1,2,3 and 4 mm	Multi-unit abutments inheights of 1,2,3 and 4 mm
Ball attachments	Ball attachments inheights of 2,3,4,5, and 6mm	Ball attachments inheights of 1,2,3,4,5, and 6mm
Healing Caps 3.8 mmdiameter	Healing Cap in 3,4,5,6,7mm height	Healing Abutment in2,3,4,5 and 6 mm heightCortex K090709 Healingabutment 7mm height
Healing Caps 4.6 mmdiameter	Healing cap in 2,3,4,5,6, and 7mm height	Healing Abutment in 2,3,4,5, and 6 mm heightCortex K090709 Healing abutment 7mm height
Healing Caps 5.5 mmdiameter	Healing cap in 2,3,4,5,6 and 7mm height	Healing Abutment in 2,3,4,5,and 6mm heightCortex K090709 Healing abutment 7mm height
Healing Caps 6.3 mmdiameter	Healing Caps in 2,3,4 and 5 mm height	Cortex K090709 Healing Abutments in 2,3, 4 and 5 mm height
Standard TitaniumAbutment	Standard Titanium Abutment with heights of 5,7,9, and 11 mm	Straight Titanium Abutment with height of 5,7,9 and 11 mm
Standard NarrowAbutment	Standard narrow abutment with heights of 5,7,9 and 11 mm	Straight narrow abutment with heights of 5, 7, 9, and 11mm
Standard WideAbutment	Standard wide abutment with heights of 9 mm	Straight wide abutment with heights of 5,7,9,and 11 mm
Standard ShoulderAbutment	Standard shoulder abutment in heights of 1,2,3 and 4mm	Shoulder abutment in heights of 1,2,3 and 4mm
Standard WideShoulder Abutment	Standard Wide Shoulder Abutment with heights of 1,2,3 mm	Wide Shoulder Abutment with heights of 1,2 ,and 3mm
Standard 15° Abutment	Standard 15° Abutment with heights of 1,2,3 mm	Standard 15° Abutment with heights of 1,2,3 mm
Standard 25° Abutment	Standard 25° Abutment with heights of 1,2,3 mm	Standard 25° Abutment with heights of 1,2, and 3mm
Denture LockAbutments *	Flat abutment in heights of 1,2,3,4,5,and 6 mm	Zest K083324 Locator abutment in heights of 1,2,3,4,5 and 6 mm
Standard OverdentureAbutment*	Overdenture abutment in 0.5, 1.5, and 2.5 mm heights	Cortex K090709 Clever click attachment with heights of 0,1,2,3,4,5 mm
Angled OverdentureAbutment*	15° and 25° overdenture abutments in heights of 1,2, and 3 mm and cover heights of 1,2 and 3 mm	17° and 30° Angled multi-unit abutment in heights of 1, 2 and 3 mmCortex K090709 Multi-Unit angulated
		abutments 1,2, and 3mm heights with coverheights in 1,2,3 mm
UCLA 4.5mm diameter	Castable abutments indiameters 4.5mm	Cortex K090709Castable abutments4.5mm diameter

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*These models of abutments are not for single crown use.

Conclusion:

OsseOne Dental Implant System is substantially equivalent to SpiralTech Dental Implant System. They both have the same indications for use, are of the same material, and have internal hex connections. The abutments, healing caps, and angled abutments are offered in similar designs and heights. Performance testing demonstrates substantial equivalence to the identified 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.