Who is the manufacturer of ATLANTIS Abutment for HIOSSEN ET implant?

Dentsply Sirona filed the 510(k) submission for ATLANTIS Abutment for HIOSSEN ET implant (K160626).

What is the FDA product code for ATLANTIS Abutment for HIOSSEN ET implant?

NHA. It is classified under 21 CFR 872.3630 as a Class 2 device in the Dental panel.

What is the regulatory pathway for ATLANTIS Abutment for HIOSSEN ET implant?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ATLANTIS Abutment for HIOSSEN ET implant?

Osseospeed™ Profile EV (K130999); HIOSSEN Implant System (K140934).

Who can help prepare an FDA 510(k) submission like ATLANTIS Abutment for HIOSSEN ET implant?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ATLANTIS Abutment for HIOSSEN ET implant

K160626 · Dentsply Sirona · NHA · Aug 29, 2016 · Dental

Device Facts

Record ID	K160626
Device Name	ATLANTIS Abutment for HIOSSEN ET implant
Applicant	Dentsply Sirona
Product Code	NHA · Dental
Decision Date	Aug 29, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3630
Device Class	Class 2
Attributes	Therapeutic

Intended 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 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.

Device Story

Patient-specific dental abutment fabricated via CAD/CAM technology; interfaces with HIOSSEN ET implants. Inputs: clinician-provided prescription/anatomical data. Transformation: CAD/CAM design and manufacturing process. Outputs: custom titanium, zirconia, or gold-shaded titanium abutments. Used in dental clinics by clinicians to support screw-retained, cement-retained, or friction-fit (Conus) prostheses. Benefits: provides customized substructure for final dental restorations, improving prosthetic fit and function for edentulous patients.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including mechanical design analysis, dimensional analysis, and static/dynamic compression-bending testing per ISO 14801.

Technological Characteristics

Materials: Titanium alloy, Zirconia. Interface: 11° conical internal hex connection. Dimensions: Platform diameters 3.5mm to 7.0mm; abutment heights 4mm to 15mm; angulation up to 30°. Manufacturing: CAD/CAM. Connectivity: None.

Indications for Use

Indicated for partially or completely edentulous patients requiring single or multiple tooth prosthetic support in the mandible or maxilla using endosseous implants.

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

Osseospeed™ Profile EV (K130999)
HIOSSEN Implant System (K140934)

Related Devices

K161030 — ATLANTIS Abutment for CONELOG implant · Dentsply Sirona · Aug 26, 2016
K183106 — TruAbutment DS · Truabutment, Inc. · Jan 29, 2020
K193529 — ATLANTIS Abutment for MIS Conical Connection Implants · Dentsply Sirona · Mar 5, 2020
K172225 — Atlantis Abutment for MIS Implant · Dentsply Sirona · Nov 30, 2017
K233857 — Neodent Implant System Custom Abutments · JJGC Indústria e Comércio de Materiais Dentários S.A. · May 2, 2024

Submission Summary (Full Text)

{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) 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 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: - 2. 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 IMPLANTS MANUFACTURING GMBH | | HIOSSEN Implant System (Reference Predicate Device) | K140934 | HIOSSEN INC | #### 4. Description of Device: 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. {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) | Implant Manufacturer | Interface | ATLANTISTM Abutment for HIOSSEN ET implant | ATLANTISTM Crown Abutment for HIOSSEN ET implant | ATLANTISTM Conus Abutment for HIOSSEN ET implant (Custom) | ATLANTISTM Conus Abutment HIOSSEN ET implant (Overdenture) | |-------------------------|-----------------------------------------------------------------------------------------------------|---------------------------------------------------------------|--------------------------------------------------------------|--------------------------------------------------------------------------|---------------------------------------------------------------------------| | HIOSSEN INC | HIOSSEN Implant System (HIOSSEN ET 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-shaded titanium (Gold-Hue) | Titanium | 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. #### 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. 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. {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. | Implant Manufacturer | Trade Name | Abutment Platform 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 devices ATLANTIST™ Abutment for HIOSSEN ET implant (Proposed Device) | OsseoSpeed Profile EV (K130999) (Primary Predicate) | HIOSSEN Implant System (K140934) (Reference Predicate) | Summary of differences in the indications for use | | | The ATLANTIST™ 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. | Implants: The ASTRA TECH Implant System – OsseoSpeed Profile EV implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols: Replacing missing teeth in single or multiple unit applications in the mandible or maxilla. Immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge Especially indicated for us in soft bone applications where implants with other implant surface treatment may be less effective Immediate and early loading for all indications Together with immediate loading protocol in all indications, except in single tooth situations in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate Only together with Profile EV components, Implant Driver Profile EV, Radiographic Implant Guides Profile EV and non-Indexed prosthetic components | The HIOSSEN Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. ETIII SA Ultra-Wide Fixture is intended to be used in the molar region. | The indications for use of the proposed device are similar to the indications for use of the primary predicate device. The difference is that the primary predicate device also includes the indications for use of the implants, which is not the subject of this submission. | | | The ATLANTIST™ 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. | Abutments: ASTRA TECH Implant System™- OsseoSpeed EV abutments are intended to be used in conjunction with ASTRA TECH Implant System™-OsseoSpeed EV in fully edentulous or partially edentulous maxillary and/or mandibular arches. | | The indications for use of the reference predicate device cover the entire dental system. | | | The ATLANTIST™ 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. | | | The indications for use are similar. The difference between the proposed device and the reference predicate device 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. | | | ATLANTIST™ products are compatible with the implants shown in the table below. | | | | | | Implant Manufacturer | Trade Name | Abutment Platform Diameter | Implant Diameter | | | HIOSSEN INC | HIOSSEN ET III SA Fixture Mini | Ø3,5mm | Ø3,5mm | | | | 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 | | | ATLANTISTM Abutment for HIOSSEN ET implant (Proposed Device) | OsseoSpeed Profile EV (K130999) (Primary Predicate) | HIOSSEN Implant System (K140934) (Reference Predicate) | Summary of differences in the indications for use | | | | The ATLANTIST™ 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 prostheses, in the mandible or maxilla. The prosthesis can be cemented, screw retained or friction fit to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant. | | | | | | The ATLANTIST™ Crown Abutment is intended for use with an endosseous implant to function as a substructure that also serves as the final restoration, in partially or completely edentulous patients. The prosthesis is screw retained. The abutment screw is intended to secure the ATLANTIST™ 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. The abutment screw is intended to secure the ATLANTIS Abutment to the endosseous implant. | | | | | | ATLANTISTM Abutment, ATLANTISTM Crown Abutment and ATLANTISTM Conus Abutment are compatible with ASTRA TECH Implant System 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 | Element | 510(k) | Prosthesis Attachment | Restoration | Abutment Platform Diameter | Abutment angle | Connection | Material Implant | Material: Abutment | Material: Screw | Proposed Device ATLANTISTM Abutment for HIOSSEN ET implants | Primary Predicate Device OsseoSpeed Profile EV K130999 | Reference Predicate Device HIOSSEN Implant System K140934 | Summary of differences | |---------|--------|-----------------------|-------------|----------------------------|----------------|------------|------------------|--------------------|------------------------------|-------------------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------| | | | | | | | | | | | To be assigned | | | | | | | | | | | | | | | Screw-retained Cement-retained Friction Fit | Screw-retained Cement-retained | No difference between the proposed and the primary predicate device. The reference device does not indicate friction fit. | | | | | | | | | | | | | 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 designed to fit the HIOSSEN ET interface. Therefore, no difference between the proposed device and the reference predicate device. | | | | | | | | | | | | Straight, up to 30° | Straight, up to 30° | Straight, up to 30° | No difference. | | | | | | | | | | | | Internal hex connection | Internal conical connection | Internal hex connection | There is no difference between the proposed device and the reference predicate device. | | | | | | | | | | | | NA | Titanium | Titanium | The proposed device is an abutment. | | | | | | | | | | | | 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.