The ATLANTIS™ Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single tooth prosthesis, in mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment screw is intended to secure the ATLANTIS Abutment to the endosseous implant.

The ATLANTIS™ Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in a partially or completely edentulous patient. The abutment screw is intended to secure the ATLANTIS Crown Abutment to the endosseous implant.

The ATLANTIS™ Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is attachment-retained by friction fit to the abutment screw is intended to secure the ATLANTIS Conus Abutment to the endosseous implant.

ATLANTISTM products are compatible with the implants shown in the table below.

Implant Manufacturer - HIOSSEN INC

Trade Name Abutment Platform Diameter HIOSSEN ET III SA Fixture Mini 03.5mm HIOSSEN ET III SA Fixture Regular 04.0, 4.5, 5.0, 6.0, 7.0 mm

Implant Diameter 03,5mm Ø4.0. 4.5. 5.0. 6.0. 7.0 mm

Device Description

The proposed ATLANTIS™ Abutment for HIOSSEN ET implant is an endosseous dental implant abutment. The subject device is provided for implant diameter (03.5, 4.0, 4.5, 5.0. 6.0 and 7.0 mm) and three designs: ATLANTIS™ Abutment for HIOSSEN ET implant, ATLANTIS™ Crown Abutment for HIOSSEN ET implant and ATLANTIS™ Conus Abutment for HIOSSEN ET implant, see table 5-1. All are patient-specific abutments fabricated using CAD/CAM technology at DENTSPLY Implant sites. Each abutment is designed according to prescription instructions from the clinician to support a screw-retained, cement-retained or friction fit prosthesis.

The coronal portion of the ATLANTIS™ Abutment can be fabricated as a conventional abutment for prosthesis attachment (ATLANTIS™ Abutment or ATLANTIS™ Conus Abutment) or fabricated as a single tooth final restoration onto which porcelain is added (ATLANTIS™ Crown Abutment). The ATLANTIS™ abutment interface is compatible with the HIOSSEN ET implants from the HIOSSEN Implant System (K140934).

The HIOSSEN ET implant interface is a slight conical (11°) internal hex connection and provided for implant platform diameter Mini (3.5 mm), and Regular (4.0, 4.5, 5.0, 6.0 and 7.0 mm). The abutment diameter ranges from 3.3 to 13 mm. the maximum abutment height is 15 mm above implant interface and the minimum abutment height is 4 mm above the transmucosal collar. The abutment is provided straight and up to 30° of angulation.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the ATLANTIS™ Abutment for HIOSSEN ET implant, a dental implant abutment. It is a submission to demonstrate substantial equivalence to legally marketed predicate devices, rather than a study designed to meet specific performance criteria for a novel AI device. Therefore, much of the requested information regarding acceptance criteria, performance metrics, sample sizes for test/training sets, expert involvement, and ground truth establishment is not directly applicable in the typical sense for AI/ML medical devices.

However, I can extract information related to the device's characteristics, testing performed to establish substantial equivalence, and general "performance" in terms of its mechanical properties and compatibility.

Here's a breakdown of the relevant information:

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

The submission does not explicitly define "acceptance criteria" in the way one would for an AI model's sensitivity, specificity, or accuracy. Instead, it relies on demonstrating that the proposed device is mechanically safe and compatible, comparable to existing predicate devices.

Feature/Test	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Material composition similar to predicate devices with established biocompatibility. (Implied: No adverse biological reactions)	"The results of biocompatibility testing conducted for the predicate device, OsseoSpeed Profile EV (K130999), are valid because the material composition of the proposed device is similar to the ATLANTIS™ Abutments covered by the predicate device, OsseoSpeed Profile EV (K130999). Therefore, no additional biocompatibility testing has been conducted."
Sterility	Same materials and sterilization cycle as predicate devices with established sterility. (Implied: Device is sterile)	"The sterility testing conducted for the predicate device, OsseoSpeed Profile EV (K130999), was conducted with the same materials and same sterilization cycle. Therefore, no additional sterility testing was required for the proposed device, ATLANTIS™ Abutment for HIOSSEN ET implant."
Mechanical Strength	Meets standards for dental implants (e.g., ISO 14801) for intended use. (Implied: Withstands static and dynamic forces in the oral cavity)	"Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence includes mechanical design analysis, dimensional analysis, and static and dynamic compression-bending testing according to ISO 14801 Dental-implants Dynamic Fatigue Test for Endosseous Dental Implants." "Mechanical testing results show that the ATLANTIS™ Abutment for HIOSSEN ET implant has sufficient strength for its intended use."
Compatibility	Compatible with specified implant diameters (3.5, 4.0, 4.5, 5.0, 6.0, 7.0 mm) from HIOSSEN ET implants. (Implied: Physically fits and functions with the specified implants)	"Compatibility analysis shows that the ATLANTIS™ Abutment for HIOSSEN ET implant is compatible with the Mini (3.5 mm) and Regular (4.0, 4.5, 5.0, 6.0 and 7.0 mm) HIOSSEN ET implants." Furthermore, the tables detail compatibility with HIOSSEN ET implant interfaces for different abutment types (Titanium, Zirconia, Gold-shaded titanium) and sizes.
Indications for Use (Similarity)	Proposed indications are similar to predicate devices. (Implied: Device is suitable for similar clinical applications as already marketed devices)	The document explicitly compares the proposed device's indications for use with two predicate devices (OsseoSpeed Profile EV and HIOSSEN Implant System). It states, "The indications for use of the proposed device are similar to the indications for use of the primary predicate device." And "The indications for use are similar. The difference... is that the prosthesis, in addition to screw-retained restoration or cement retained restoration, can be attachment-retained (by friction fit) to the proposed device." The document aims to demonstrate that any differences do not raise new questions of safety or effectiveness.

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

This submission does not detail "test sets" in the context of clinical data for an AI/ML device. The non-clinical performance data refers to mechanical and dimensional testing of the abutments themselves.

Sample Size: Not specified for mechanical testing beyond "test data." For biocompatibility and sterility, no new samples were tested; reliance was placed on predicate device data.
Data Provenance: The testing was non-clinical (mechanical, dimensional), likely performed in a lab setting by the manufacturer, Dentsply Sirona. The document does not specify a country of origin for this testing or whether it was retrospective or prospective, as these terms are typically applied to patient data.

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. The device is a physical medical device (dental implant abutment), not an AI/ML algorithm requiring expert-labeled ground truth for diagnostic or prognostic purposes. The performance assessment relates to engineering specifications and material properties, not interpretations by experts.

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

This information is not applicable for the same reasons as point 3.

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 as the device is a physical dental abutment, not an AI-powered diagnostic or assistive tool for human readers.

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

This information is not applicable. The device is a physical abutment, not an algorithm.

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

The "ground truth" here is based on:

Engineering Standards: Compliance with ISO 14801 for mechanical properties.
Material Science: Properties of titanium alloy and zirconia.
Dimensional Specifications: Precise fit with the specified HIOSSEN ET implants.
Predicate Device Data: Historical safety and effectiveness data from previously cleared similar devices (K130999 and K140934) regarding biocompatibility, sterility, and performance.

8. The sample size for the training set

This information is not applicable as the device is a physical medical device, not an AI/ML algorithm that is "trained."

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

This information is not applicable as the device is a physical medical device, not an AI/ML algorithm.

Summary

{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 29, 2016

Dentsply Sirona Ms. Helen Lewis Director, Corporate Regulatory Affairs 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17404

Re: K160626

Trade/Device Name: ATLANTISTM Abutment for HIOSSEN ET implant Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous dental implant abutment Regulatory Class: II Product Code: NHA Dated: July 21, 2016 Received: July 22, 2016

Dear Ms. Lewis:

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 Industry and Consumer Education at its toll-free 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 Industry and Consumer Education 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,

Image /page/1/Picture/8 description: The image shows a signature and the name "Tina Kiang" written in black ink. The signature is illegible and consists of a series of loops and lines. The text "Tina Kiang" is written in a simple, sans-serif font and is positioned to the right of the signature. There is a faint FDA logo in the background.

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K160626

Device Name

ATLANTISTM Abutment for HIOSSEN ET implant

Indications for Use (Describe)

ATLANTISTM products are compatible with the implants shown in the table below.

Implant Manufacturer - HIOSSEN INC

Trade Name Abutment Platform Diameter HIOSSEN ET III SA Fixture Mini 03.5mm HIOSSEN ET III SA Fixture Regular 04.0, 4.5, 5.0, 6.0, 7.0 mm

Implant Diameter 03,5mm Ø4.0. 4.5. 5.0. 6.0. 7.0 mm

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Dentsply Sirona 221 West Philadelphia Street Suite 60 York, PA 17404

Image /page/3/Picture/1 description: The image shows the logo for Dentsply Sirona. The logo consists of a stylized leaf-like shape on the left, followed by the text "Dentsply" on the top line and "Sirona" on the bottom line. The text is in a simple, sans-serif font.

SECTION 5. 510(k) SUMMARY for

ATLANTISTM Abutment for HIOSSEN ET implant

1. Submitter Information:
  Dentsply Sirona 221 West Philadelphia Street Suite 60 York, PA 17401

Contact Person:	Helen Lewis
Telephone Number:	717-487-1332
Fax Number:	717-849-4343

August 17, 2016 Date Prepared:

1. Device Name:
- Proprietary Name: .

ATLANTISTM Abutments for HIOSSEN ET implant

Classification Name: Endosseous dental implant abutment
. . CFR Number:
- 21 CFR 872.3630 Device Class: II
NHA Product Code: .

3. Predicate Device:

Predicate Device Name	510(k)	Company Name
Osseospeed™ Profile EV(Primary Predicate Device)	K130999	DENTSPLY IMPLANTSMANUFACTURING GMBH
HIOSSEN Implant System(Reference Predicate Device)	K140934	HIOSSEN INC

4. Description of Device:

{4}------------------------------------------------

SECTION 5. 510(k) SUMMARY (continued)

Table 5-1: Compatibility table (The ATLANTIS Abutment Titanium, Zirconia and Goldshaded are compatible with HIOSSEN ET implant interface (Ø3.5, 4.0, 4.5, 5.0, 6.0, 7.0 mm)

ImplantManufacturer	Interface	ATLANTISTMAbutment forHIOSSEN ETimplant	ATLANTISTMCrownAbutment forHIOSSEN ETimplant	ATLANTISTM ConusAbutmentforHIOSSENET implant(Custom)	ATLANTISTMConusAbutmentHIOSSEN ETimplant(Overdenture)
HIOSSEN INC	HIOSSENImplantSystem(HIOSSENET implant)(Ø3.5, 4.0,4.5, 5.0, 6.0,7.0 mm)	Titanium,Zirconia, Gold-shaded titanium(Gold-Hue)	Titanium,Zirconia	Titanium,Gold-shadedtitanium(Gold-Hue)	Titanium

న. Indications for Use:

The ATLANTIS™ Abutment is intended for use with an endosseous implant to support a prosthetic device in a partially or completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment. The abutment screw is intended to secure the ATLANTIS Abutment to the endosseous implant.

{5}------------------------------------------------

SECTION 5. 510(k) SUMMARY (continued)

The ATLANTIS™ Conus Abutment is intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. It is intended for use to support a removable multiple tooth prosthesis, in the mandible or maxilla. The prosthesis is attachment-retained by friction fit to the abutment. The abutment screw is intended to secure the ATLANTIS Conus Abutment to the endosseous implant.

ATLANTIS™ products are compatible with the implants shown in the table below.

ImplantManufacturer	Trade Name	AbutmentPlatform Diameter	Implant Diameter
HIOSSEN INC	HIOSSEN ET III SA Fixture Mini	Ø3,5mm	Ø3,5mm
HIOSSEN INC	HIOSSEN ET III SA Fixture Regular	Ø4.0, 4.5, 5.0, 6.0,7.0 mm	Ø4.0, 4.5, 5.0, 6.0,7.0 mm
Table 5-2: Indications for use for the proposed and the predicate devicesATLANTIST™ Abutment for HIOSSEN ETimplant (Proposed Device)	OsseoSpeed Profile EV (K130999)(Primary Predicate)	HIOSSEN Implant System (K140934)(Reference Predicate)	Summary of differences inthe indications for use
The ATLANTIST™ Abutment is intended for usewith an endosseous implant to support a prostheticdevice in a partially or completely edentulouspatient. It is intended for use to support single andmultiple tooth prosthesis, in mandible or maxilla.The prosthesis can be cemented or screw retained tothe abutment. The abutment screw is intended tosecure the ATLANTIS Abutment to the endosseousimplant.	Implants:The ASTRA TECH Implant System –OsseoSpeed Profile EV implants areintended for both one- and two-stagesurgical procedures in the followingsituations and with the following clinicalprotocols:Replacing missing teeth in single ormultiple unit applications in themandible or maxilla. Immediate placement in extractionsites and in situations with apartially or completely healedalveolar ridge Especially indicated for us in softbone applications where implantswith other implant surface treatmentmay be less effective Immediate and early loading for allindications Together with immediate loadingprotocol in all indications, except insingle tooth situations in soft bone(type IV) where implant stabilitymay be difficult to obtain andimmediate loading may not beappropriate Only together with Profile EVcomponents, Implant Driver ProfileEV, Radiographic Implant GuidesProfile EV and non-Indexedprosthetic components	The HIOSSEN Implant System is indicatedfor use in partially or fully edentulousmandibles and maxillae, in support of singleor multiple-unit restorations including;cemented retained, screw retained, oroverdenture restorations, and final ortemporary abutment support for fixedbridgework. It is intended for delayedloading. ETIII SA Ultra-Wide Fixture isintended to be used in the molar region.	The indications for use of theproposed device are similar to theindications for use of the primarypredicate device. The difference isthat the primary predicate device alsoincludes the indications for use of theimplants, which is not the subject ofthis submission.
The ATLANTIST™ Crown Abutment is intendedfor use with an endosseous implant to function as asubstructure that also serves as the final restoration,in a partially or completely edentulous patient. Theabutment screw is intended to secure the ATLANTISCrown Abutment to the endosseous implant.	Abutments:ASTRA TECH Implant System™-OsseoSpeed EV abutments are intendedto be used in conjunction with ASTRATECH Implant System™-OsseoSpeedEV in fully edentulous or partiallyedentulous maxillary and/or mandibulararches.		The indications for use of thereference predicate device cover theentire dental system.
The ATLANTIST™ Conus Abutment is intendedfor use with an endosseous implant to support aprosthetic device in partially or completelyedentulous patients. It is intended for use to support aremovable multiple tooth prosthesis, in the mandibleor maxilla. The prosthesis is attachment-retained byfriction fit to the abutment. The abutment screw isintended to secure the ATLANTIS Conus Abutmentto the endosseous implant.			The indications for use are similar.The difference between the proposeddevice and the reference predicatedevice is that the prosthesis, inaddition to screw-retained restorationor cement retained restoration, can beattachment-retained (by friction fit)to the proposed device.
ATLANTIST™ products are compatible with theimplants shown in the table below.
ImplantManufacturer	Trade Name	AbutmentPlatformDiameter	ImplantDiameter
HIOSSEN INC	HIOSSEN ET III SAFixture Mini	Ø3,5mm	Ø3,5mm
	HIOSSEN ET III SAFixture Regular	Ø4.0, 4.5,5.0, 6.0, 7.0mm	Ø4.0, 4.5,5.0, 6.0, 7.0mm
ATLANTISTM Abutment for HIOSSEN ETimplant (Proposed Device)	OsseoSpeed Profile EV (K130999)(Primary Predicate)	HIOSSEN Implant System (K140934)(Reference Predicate)	Summary of differences inthe indications for use
	The ATLANTIST™ Abutment isintended for use with an endosseousimplant to support a prosthetic device ina partially or completely edentulouspatient. It is intended for use to supportsingle and multiple tooth prostheses, inthe mandible or maxilla. The prosthesiscan be cemented, screw retained orfriction fit to the abutment. Theabutment screw is intended to secure theabutment to the endosseous implant.
	The ATLANTIST™ Crown Abutmentis intended for use with an endosseousimplant to function as a substructure thatalso serves as the final restoration, inpartially or completely edentulouspatients. The prosthesis is screwretained. The abutment screw is intendedto secure the ATLANTIST™ Abutment tothe endosseous implant.
	The ATLANTIS Conus Abutment isintended for use with an endosseousimplant to support a prosthetic device inpartially or completely edentulouspatients. It is intended for use to supporta removable multiple tooth prosthesis, inthe mandible or maxilla. The prosthesisis attachment-retained by friction fit tothe abutment. The abutment screw isintended to secure the ATLANTISAbutment to the endosseous implant.
	ATLANTISTM Abutment,ATLANTISTM Crown Abutment andATLANTISTM Conus Abutment arecompatible with ASTRA TECH ImplantSystem Profile EV

6. Substantial Equivalence:

Technological Characteristics:

ATLANTIS™ Abutment for HIOSSEN ET implant is a patient specific restorative device designed under the control of DENTSPLY Implants and manufactured by DENTSPLY Implants using CAD/CAM technology.

Table 5-2 and 5-3 below summarizes the differences and similarities of the subject and predicate devices.

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------

Table 5-3: Similarities and differences between the proposed and the predicate devices

Material: Screw	Proposed DeviceATLANTISTM Abutment for HIOSSEN ETimplants	Primary PredicateDeviceOsseoSpeed ProfileEVK130999	ReferencePredicate DeviceHIOSSENImplant SystemK140934
	To be assigned
	Screw-retainedCement-retainedFriction Fit	Screw-retainedCement-retained	No difference between theproposed and the primarypredicate device. The referencedevice does not indicate frictionfit.
	Single or Multi-unit	Single or Multi-unit	No difference.
3.5, 4.0, 4.5, 5.0, 6.0, 7.0	3.0, 4.2, 4.8	3.5, 4.0, 4.5, 5.0, 6.0,7.0	The proposed device is designedto fit the HIOSSEN ETinterface. Therefore, nodifference between the proposeddevice and the referencepredicate device.
Straight, up to 30°	Straight, up to 30°	Straight, up to 30°	No difference.
Internal hex connection	Internal conicalconnection	Internal hexconnection	There is no difference betweenthe proposed device and thereference predicate device.
NA	Titanium	Titanium	The proposed device is anabutment.
Titanium alloy, Zirconia	Titanium alloy, Zirconia	Titanium alloy,Zirconia	No difference.
Titanium alloy	Titanium alloy	Titanium alloy	No difference.

{9}------------------------------------------------

Biocompatibility

The results of biocompatibility testing conducted for the predicate device, OsseoSpeed Profile EV (K130999), are valid because the material composition of the proposed device is similar to the ATLANTIS™ Abutments covered by the predicate device, OsseoSpeed Profile EV (K130999). Therefore, no additional biocompatibility testing has been conducted.

Sterility

The sterility testing conducted for the predicate device, OsseoSpeed Profile EV (K130999), was conducted with the same materials and same sterilization cycle. Therefore, no additional sterility testing was required for the proposed device, ATLANTIS™ Abutment for HIOSSEN ET implant.

7. Non-Clinical Performance Data

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence includes mechanical design analysis, dimensional analysis, and static and dynamic compression-bending testing according to ISO 14801 Dental-implants Dynamic Fatigue Test for Endosseous Dental Implants.

Compatibility analysis shows that the ATLANTIS™ Abutment for HIOSSEN ET implant is compatible with the Mini (3.5 mm) and Regular (4.0, 4.5, 5.0, 6.0 and 7.0 mm) HIOSSEN ET implants. Mechanical testing results show that the ATLANTIS™ Abutment for HIOSSEN ET implant has sufficient strength for its intended use.

Conclusion Regarding Substantial Equivalence 8.

The ATLANTIS™ Abutment for HIOSSEN ET implant is an endosseous dental implant abutment which is intended to support a prosthetic device in a partially or completely edentulous patient. The ATLANTIS™ Abutment for HIOSSEN ET implant has the same intended use, incorporates the same fundamental technology, and has similar indications for use as the predicates. Osseospeed™ Profile EV (K130999) and HIOSSEN Implant System (K140934). Test data to verify the performance of the ATLANTISTM Abutment for HIOSSEN ET implant has been provided including: mechanical testing and compatibility analysis. The results of this testing, combined with the design, and intended use comparison with the predicate devices, support substantial equivalence.

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)