ATLANTIS Abutment for NobelActive 3.0

K151039 · Dentsply International, Inc. · NHA · Jan 14, 2016 · Dental

Device Facts

• Record ID: K151039
• Device Name: ATLANTIS Abutment for NobelActive 3.0
• Applicant: Dentsply International, Inc.
• Product Code: NHA · Dental
• Decision Date: Jan 14, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

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 and multiple tooth prosthesis, in the 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. 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.

Device Story

Patient-specific dental abutment fabricated via CAD/CAM technology; supports screw-retained, cement-retained, or friction-fit prostheses. Designed based on clinician prescription; interfaces with NobelActive 3.0 endosseous implants. Used by dental professionals in clinical settings to restore chewing function. Provides structural connection between implant and final restoration (crown or removable prosthesis). Benefits patient by enabling functional and aesthetic tooth replacement.

Clinical Evidence

Bench testing only. Includes mechanical design analysis, dimensional analysis, and static/dynamic compression-bending testing per ISO 14801. Compatibility analysis confirmed interface fit with NobelActive 3.0 implants.

Technological Characteristics

Patient-specific CAD/CAM fabricated abutment. Materials: Titanium alloy. Dimensions: 3.0 mm platform, 3.3-13 mm diameter, 4-15 mm height. Angulation: Straight to 30°. Connection: Internal. Sterilization: Validated cycle consistent with predicates.

Indications for Use

Indicated for partially or completely edentulous patients requiring single or multiple tooth prosthetic support in the mandible or maxilla via 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

• ATLANTIS™ Abutment for Nobel Biocare Active Implant (K093483)
• OsseoSpeed Profile EV (K130999)
• NobelActive 3.0 (K102436)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 14, 2016

DENTSPLY International, Inc. Ms. Helen Lewis Director of Corporate Regulatory Affairs Susquehanna Commerce Center 221 W. Philadelphia St., Suite 60 York, Pennsylvania 17401

Re: K151039

Trade/Device Name: ATLANTISTM Abutment for NobelActive 3.0 Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: December 10, 2015 Received: December 14, 2015

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.

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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 devicerelated 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 [phone] or [phone] 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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## SECTION 4. INDICATIONS FOR USE STATEMENT

K151039 510(k) Number (if known):

Device Name: ATLANTISTM Abutment for NobelActive 3.0

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 the 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.

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 attachmentretained by friction fit to the abutment. The abutment screw is intended to secure the ATLANTIS™ Conus Abutment to the endosseous implant.

ATLANTIS™ Abutment for NobelActive 3.0 is compatible with the NobelActive 3.0 implant.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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### 510(k) SUMMARY for ATLANTISTM Abutment for NobelActive 3.0

- 1. Submitter Information:
DENTSPLY International, Inc. Susquehanna Commerce Center 221 West Philadelphia Street, Ste. 60 York, PA 17401

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

Date Prepared: 12 January 2015

- 2. Device Name:
- Proprietary Name: .
- Classification Name: .
- CFR Number: .
- Device Class: .
- Product Code: .

ATLANTISTM Abutment for NobelActive 3.0 Endosseous dental implant abutment 21 CFR 872.3630

- Class II NHA
#### 3. Predicate Devices:

The subject device is substantially equivalent in indications and design principles to the following legally marketed predicate devices:

| Table 3.1 | | | |
|------------------------------------------------------------------------------------|---------|-------------------|--|
| Predicate Device Name | 510(k) | Company Name | |
| ATLANTISTM Abutment for Nobel Biocare Active<br>Implant (Primary Predicate Device) | K093483 | Astra Tech Inc. * | |
| OsseoSpeed Profile EV (Reference Predicate Device) | K130999 | DENTSPLY Implants | |
| NobelActive 3.0 (Reference Predicate Device) | K102436 | Nobel Biocare AB | |

* = Astra Tech Inc. is the original applicant. 510(k) was transferred to DENTSPLY International Inc. after purchase of Astra Tech Inc.

#### Description of Device: 4.

ATLANTISTM Abutment for NobelActive 3.0 is provided in three designs: ATLANTISTM Abutment for NobelActive, ATLANTIS™ Crown Abutment for NobelActive and ATLANTISTM Conus Abutment for NobelActive. All are patient specific fabricated abutments using CAD/CAM technology. Each abutment is designed according to prescription instructions from the clinician to support a screw-retained. cement-retained or friction fit prosthesis.

Traditional 510(k) ATLANTISTM Abutment for NobelActive 3.0 DENTSPLY International

### DENTSPLY International

World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street Suite 60W York, PA 17401 [phone] Fax [phone] www.dentsply.com

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The coronal portion of the ATLANTIS™ abutment can be fabricated as a conventional abutment for prosthesis attachment (ATLANTIS™ Abutment or ATLANTISTM Conus Abutment) or fabricated as a single tooth final restoration onto which porcelain is added (ATLANTISTM Crown Abutment). The implant/abutment interface is compatible with the NobelActive 3.0 implant.

ATLANTISTM Abutment for NobelActive 3.0 has an internal connection and is provided for implant platform diameter Ø3.0 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.

#### Indications for Use: 5.

The ATLANTISTM 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 the mandible or maxilla. The prosthesis can be cemented or screw retained to the abutment screw is intended to secure the ATLANTISTM 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. The abutment screw is intended to secure the ATLANTIS™ Conus Abutment to the endosseous implant.

ATLANTIS™ Abutment for NobelActive 3.0 is compatible with the NobelActive 3.0 implant.

- 6. Substantial Equivalence:
# Technological Characteristics.

ATLANTISTM Abutment for NobelActive 3.0 is a patient specific restorative device designed under the control of DENTSPLY and manufactured by DENTSPLY using CAD/CAM technology.

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Table 6.1 below describes the differences and similarities of the subject and predicate devices.

| Table 6.1 | | | | | Table 6.1 | | | | |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------|----------------------------------------------------|------------------------------------------------|
| | Subject Device | | Predicate Devices | | | Subject Device | Predicate Devices | | |
| | DENTSPLY<br>Implants<br>ATLANTISTM<br>Abutment for<br>NobelActive 3.0 | Astra Tech, Inc.<br>ATLANTISTM<br>Abutment for<br>Nobel Biocare<br>Active Implant<br>K093483 | DENTSPLY<br>Implants<br>OsseoSpeed™<br>Profile EV<br>K130999 | Nobel Biocare AB<br>NobelActive 3.0<br>K102436 | | DENTSPLY<br>Implants<br>ATLANTISTM<br>Abutment for<br>NobelActive 3.0 | Astra Tech, Inc.<br>ATLANTISTM<br>Abutment for<br>Nobel Biocare<br>Active Implant | DENTSPLY<br>Implants<br>OsseoSpeedTM<br>Profile EV | Nobel Biocare AB<br>NobelActive 3.0<br>K102436 |
| Indications<br>for Use | The<br>ATLANTISTM<br>Abutment is<br>intended for use<br>with an<br>endosseous<br>implant to support<br>a prosthetic<br>device in a<br>partially or<br>completely<br>edentulous<br>patient. It is<br>intended for use<br>to support single<br>and multiple tooth<br>prosthesis, in the<br>mandible or<br>maxilla. The<br>prosthesis can be<br>cemented or<br>screw retained to<br>the abutment. The<br>abutment screw is<br>intended to secure<br>the ATLANTISTM<br>Abutment to the<br>endosseous<br>implant.<br>The<br>ATLANTISTM<br>Crown<br>Abutment is<br>intended for use<br>with an<br>endosseous<br>implant to<br>function as a<br>substructure that<br>also serves as the<br>final restoration,<br>in a partially or | The<br>ATLANTISTM<br>Abutment is<br>intended for use<br>with an<br>endosseous<br>implant to support<br>a prosthetic<br>device in a<br>partially or<br>completely<br>edentulous<br>patient. It is<br>intended for use<br>to support single<br>and multiple tooth<br>prosthesis, in the<br>mandible or<br>maxilla. The<br>prosthesis can be<br>cement or screw<br>retained to the<br>abutment. The<br>abutment screw is<br>intended to secure<br>the abutment to<br>the endosseous<br>implant.<br>This device is<br>compatible with<br>the following<br>manufacturers'<br>implant systems:<br>The titanitun and<br>zirconia<br>abutments are<br>compatible with<br>the Nobel<br>Biocare's<br>NobelActive<br>Implants.<br>Please note: This | Implants:<br>The ASTRA<br>TECH Implant<br>System -<br>OsseoSpeed<br>Profile EV<br>implants are<br>intended for both<br>one- and two-<br>stage surgical<br>procedures in the<br>following<br>situations and<br>with the following<br>clinical protocols:<br>• replacing<br>missing teeth in<br>single or multiple<br>unit applications<br>in the mandible or<br>maxilla.<br>• immediate<br>placement in<br>extraction sites<br>and in situations<br>with a partially or<br>completely healed<br>alveolar ridge<br>• especially<br>indicated for use<br>in soft bone<br>applications<br>where implants<br>with other implant<br>surface treatments<br>may be less<br>effective<br>• immediate and<br>early loading for<br>all indications<br>• together with<br>immediate<br>loading protocol | The NobelActive<br>3.0 mm implant is<br>indicated for use.<br>In the treatment of<br>missing maxillary<br>lateral incisors or<br>the mandibular<br>central and lateral<br>incisors to support<br>prosthetic devices,<br>such as artificial<br>teeth, In order to<br>restore chewing<br>function in<br>partially<br>edentulous<br>patients. The<br>NobelActive 3.0<br>implants may be<br>put into immediate<br>function provided<br>that stability<br>requirements<br>detailed in the<br>manual are<br>satisfied. | | | K093483 | K130999 | |
| Table 6.1 | Subject Device | Predicate Devices | | Design | | | | | |
| | DENTSPLY<br>Implants | Astra Tech, Inc.<br>ATLANTISTM<br>Abutment for<br>Nobel Biocare<br>Active Implant | DENTSPLY<br>Implants<br>OsseoSpeed™<br>Profile EV | Nobel Biocare AB<br>NobelActive 3.0 | Prosthesis<br>Attachment | Screw-retained<br>Cement-retained<br>Friction Fit | Screw-retained<br>Cement-retained | Screw-retained<br>Cement-retained<br>Friction Fit | Screw-retained<br>Cement-retained |
| | ATLANTISTM<br>Abutment for<br>NobelActive 3.0 | K093483 | K130999 | K102436 | Restoration | Single or Multi-<br>unit | Single or Multi-<br>unit | Single or Multi-<br>unit | Single or Multi-<br>unit |
| | completely<br>edentulous<br>patient. The<br>abutment screw is<br>intended to secure<br>the ATLANTISTM<br>Crown Abutment<br>to the endosseous<br>implant.<br><br>The<br>ATLANTISTM<br>Conus Abutment<br>is intended for use<br>with an<br>endosseous<br>implant to support<br>a prosthetic<br>device in partially<br>or completely<br>edentulous<br>patients. It is<br>intended for use<br>to support a<br>removable<br>multiple tooth<br>prosthesis, in the<br>mandible or<br>maxilla. The<br>prosthesis is<br>attachment-<br>retained by<br>friction fit to the<br>abutment. The<br>abutment screw is<br>intended to secure<br>the ATLANTISTM<br>Conus Abutment<br>to the endosseous<br>implant.<br><br>ATLANTISTM<br>Abutment for<br>NobelActive 3.0<br>is compatible with<br>the Ø3.0 mm | device may be<br>used in an early<br>load situation, but<br>is dependent on<br>the specific<br>implant system<br>and protocol used<br>by the dental<br>professional.<br><br>Highly angled<br>abutments (i.e. 30<br>degrees) on<br>implants with<br>diameters less<br>than 4 mm are<br>intended for the<br>anterior region of<br>the mouth and are<br>not intended for<br>the posterior<br>region due to<br>limited strength of<br>the implant. | in all indications,<br>except in single<br>tooth situations in<br>soft bone (type<br>IV) where implant<br>stability may be<br>difficult to obtain<br>and immediate<br>loading may not<br>be appropriate<br>• only together<br>with Profile EV<br>components,<br>Implant Driver<br>Profile EV,<br>Radiographic<br>Implant Guides<br>Profile EV and<br>non-Indexed<br>prosthetic<br>components<br><br>Abutments:<br>ASTRA TECH<br>Implant<br>System™-<br>OsseoSpeed EV<br>abutments are<br>intended to be<br>used in<br>conjunction with<br>ASTRA TECH<br>Implant<br>System™-<br>OsseoSpeed EV<br>in fully<br>edentulous or<br>partially<br>edentulous<br>maxillary and/or<br>mandibular<br>arches.<br><br>The<br>ATLANTISTM | | Abutment<br>Diameter | 3.0 | 3.5, 4.3, 5.0 | 3.0, 4.2, 4.8 | 3.0 |
| Subject Device | Predicate Devices | | | Abutment<br>Angle | Straight, up to 30° | Straight, up to 30° | Straight, up to 30° | Straight, up to 30° | |
| DENTSPLY<br>Implants<br>ATLANTISTM<br>Abutment for<br>NobelActive 3.0 | Astra Tech, Inc.<br>ATLANTISTM<br>Abutment for<br>Nobel Biocare<br>Active Implant | DENTSPLY<br>Implants<br>OsseoSpeed™<br>Profile EV | Nobel Biocare AB<br>NobelActive 3.0 | Connection | Internal | Internal | Internal | Internal | |
| | K093483 | K130999 | K102436 | Material | | | | | |
| NobelActive<br>Implant. | | intended for use<br>with an<br>endosseous<br>implant to support<br>a prosthetic<br>device in a<br>partially or<br>completely<br>edentulous<br>patient. It is<br>intended for use<br>to support single<br>and multiple tooth<br>prostheses, in the<br>mandible or<br>maxilla. The<br>prosthesis can be<br>cemented, screw<br>retained or<br>friction fit to the<br>abutment. The<br>abutment screw is<br>intended to secure<br>the abutment to<br>the endosseous<br>implant.<br>The<br>ATLANTISTM<br>Crown Abutment<br>is intended for use<br>with an<br>endosseous<br>implant to<br>function as a<br>substructure that<br>also serves as the<br>final restoration,<br>in partially or<br>completely<br>edentulous<br>patients. The<br>prosthesis is<br>screw retained.<br>The abutment<br>screw is intended<br>to secure the | | Implant | NA | NA | Titanium | Titanium | |
| Subject Device | Predicate Devices | | | Abutment | Titanium alloy | Titanium alloy,<br>Zirconia | Titanium alloy,<br>Zirconia | Titanium alloy | |
| DENTSPLY<br>Implants<br>ATLANTISTM<br>Abutment for<br>NobelActive 3.0 | Astra Tech, Inc.<br>ATLANTISTM<br>Abutment for<br>Nobel Biocare<br>Active Implant<br>K093483 | DENTSPLY<br>Implants<br>OsseoSpeed™<br>Profile EV<br>K130999 | Nobel Biocare AB<br>NobelActive 3.0<br>K102436 | Screw | Titanium alloy | Titanium alloy | Titanium alloy | Titanium alloy | |
| | | to the endosseous<br>implant.<br>The<br>ATLANTISTM<br>Conus Abutment<br>is intended for use<br>with an<br>endosseous<br>implant to support<br>a prosthetic<br>device in partially<br>or completely<br>edentulous<br>patients. It is<br>intended for use<br>to support a<br>removable<br>multiple tooth<br>prosthesis, in the<br>mandible or<br>maxilla. The<br>prosthesis is<br>attachment-<br>retained by<br>friction fit to the<br>abutment. The<br>abutment screw is<br>intended to secure<br>the ATLANTISTM<br>Abutment to the<br>endosseous<br>implant.<br><br>ATLANTISTM<br>Abutment,<br>ATLANTISTM<br>Crown Abutment<br>and<br>ATLANTISTM<br>Conus Abutment<br>are compatible<br>with ASTRA | | | | | | | |

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# Biocompatibility

The results of biocompatibility testing conducted for the predicate devices, ATLANTIS™ Abutment for Nobel Biocare Active Implant (K093483) and OsseoSpeed Profile EV (K130999), are valid, therefore, no additional biocompatibility testing has been performed.

### Sterility

The results from the previous sterility testing are valid for the proposed device, ATLANTIS™ Abutment for NobelActive 3.0. The sterility testing conducted for the predicate devices, ATLANTIS™ Abutment for Nobel Biocare Active Implant (K093483) and OsseoSpeed Profile EV (K130999), was conducted with the same materials and same sterilization cycle. Therefore, no additional sterility testing was required.

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#### 7. Non-Clinical Performance Data.

Non-clinical testing data, 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 NobelActive 3.0 is compatible with the NobelActive 3.0 implant. Mechanical testing results show that the ATLANTISTM Abutment for NobelActive 3.0 has sufficient strength for its intended use.

# Conclusion Regarding Substantial Equivalence

The ATLANTIS™ Abutment for NobelActive 3.0 is an endosseous dental implant abutment which is intended to support a prosthetic device in a partially or completely edentulous patient. The ATLANTISTM Abutment for NobelActive 3.0 has the same intended use, incorporates the same fundamental technology, and has similar indications for use as the predicate devices ATLANTIS™ Abutment for Nobel Biocare Active Implant (K093483), OsseoSpeed Profile EV (K130999) and NobelActive 3.0 (K102436).

The subject device when compared to the predicate devices support substantial equivalence.