ATLANTIS STRAUMANN BONE LEVEL ABUTMENT

K130216 · Dentsply Implant · NHA · May 1, 2013 · Dental

Device Facts

• Record ID: K130216
• Device Name: ATLANTIS STRAUMANN BONE LEVEL ABUTMENT
• Applicant: Dentsply Implant
• Product Code: NHA · Dental
• Decision Date: May 1, 2013
• 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 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 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 partially or completely edentulous patients. The abutment screw is intended to secure the crown abutment to the endosseous implant. Atlantis™ Straumann Bone Level Abutment in Zirconia is compatible with the Ø3.3 mm Straumann Bone Level Implant.

Device Story

Patient-specific dental implant abutment; fabricated from yttria-stabilized zirconia (Y-TZP); used with titanium alloy abutment screw. Compatible with Ø3.3 mm Straumann Bone Level Implant. Supports screw-retained, cement-retained, or friction-fit prosthetic restorations. Crown Abutment design serves as both substructure and final restoration base for porcelain application. Used by dental professionals in clinical settings to restore patient dentition; provides structural interface between endosseous implant and prosthetic tooth/teeth. Benefits include patient-specific anatomical fit for improved prosthetic stability and aesthetics.

Clinical Evidence

Bench testing only. Evidence includes engineering analysis, dimensional analysis, and static and dynamic compression-bending fatigue testing conducted in accordance with ISO 14801.

Technological Characteristics

Materials: Yttria-stabilized zirconia (Y-TZP) per ISO 13356; titanium alloy abutment screw. Form factor: Patient-specific abutment, Ø3.3 mm diameter. Designs: Standard abutment and Crown Abutment. Mechanical interface: Compatible with Straumann Bone Level Implant Ø3.3 mm. Sterilization: Same processes as predicates.

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

• Atlantis™ Straumann Bone Level Abutment (K083871)
• Atlantis™ Crown Abutment in Zirconia (K110356)
• Straumann Dental Implant System (K083550)
• P.004 Implants (K062129)

Submission Summary (Full Text)

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# 510(k) Summary

# Dentsply Implants

#### MAY 1 2013

# Atlantis™ Straumann Bone Level Abutment K130216

April 30, 2013 .

Christina Lewing

### ADMINISTRATIVE INFORMATION

· Manufacturer Name

Dentsply Implants Aminogatan 1, P.O. Box 14 Mölndal, Sweden SE-431-21 Telephone: [phone] Fax: [phone]

Head of Regulatory Affairs

Official Contact:

Representative/Consultant

Linda K. Schulz Floyd G. Larson PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 Telephone: [phone] [phone] Fax: [e-mail] Email: [e-mail]

#### DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name Common Name Classification Name Classification Regulation Product Code Classification Panel Reviewing Branch

Atlantis™ Straumann Bone Level Abutment Dental implant abutment Endosseous dental implant abutment Class II, 21 CFR 872.3630 NHA Dental Products Panel Dental Devices Branch

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#### 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 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 partially or completely edentulous patients. The abutment screw is intended to secure the crown abutment to the endosseous implant.

Atlantis™ Straumann Bone Level Abutment in Zirconia is compatible with the Ø3.3 mm Straumann Bone Level Implant.

## DEVICE DESCRIPTION

Atlantis Straumann Bone Level Abutment is a patient specific dental implant abutment for screw-retained, cement-retained or friction fit restorations. Atlantis Straumann Bone Level Abutment is provided in one diameter (03.3 mm) and two designs: Atlantis Straumann Bone Level Abutment and Atlantis Straumann Bone Level Crown Abutment. The coronal portion of Atlantis Abutment is fabricated as a patient specific abutment for prosthesis attachment. The coronal portion of Atlantis Crown Abutment is fabricated as a single tooth final restoration and is shaped in the design of the final prosthesis onto which porcelain is added. Both designs are compatible with the Straumann Bone Level implant Ø3.3 mm. Atlantis abutments are made from yttria-stabilized zirconia (Y-TZP) conforming to ISO 13356 Implants for surgery-ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) and are used with a titanium alloy abutment screw.

## EQUIVALENCE TO MARKETED DEVICE

Dentsply Implants submits the following information in this Premarket Notification to demonstrate that for the purposes of FDA's regulation of medical devices Atlantis™ Straumann Bone Level Abutment is substantially equivalent in indications and design principles to the following legally marketed predicate devices:

Atlantis™ Straumann Bone Level Abutment - K083871 Atlantis™ Crown Abutment in Zirconia - K110356 Straumann Dental Implant System - K083550 P.004 Implants - K062129

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: engineering analysis, dimensional analysis, and static and dynamic

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#### 510(k) Summary

compression-bending testing according to ISO 14801 Dental-implants Dynamic Fatigue Test for Endosseous Dental Implants.

Any differences in the technological characteristics between the subject and predicate devices do not raise new issues of safety or efficacy. The data included in this submission demonstrates substantial equivalence to the predicate devices listed above.

Overall, Atlantis™ Straumann Bone Level Abutment has the following similarities to the predicate devices:

- has the same intended use, .
- . uses the same operating principle,
- incorporates the same basic design,
- incorporates the same or very similar materials, and .
- . has similar packaging and is sterilized using the same materials and processes.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem consisting of three abstract shapes that resemble human figures or stylized waves. The emblem is black, and the text is also black.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

## May 1, 2013

Dentsply Implants C/O Ms. Linda K. Schulz PaxMed International, Limited Liability Company 12264 El Camino Real, Suite 400 · SAN DIEGO CA 92130

Re: K130216

Trade/Device Name: Atlantis114 Straumann Bone Level Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: January 30, 2013 Received: January 31, 2013

#### Dear Ms. Schulz:

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); fabeling (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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [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" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kwame O. Ulmer
-s FDA

for

Anthony D. Watson, B.S., M.S., M.B.A. 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

K130216 510(k) Number:

Device Name:

Atlantis™ Straumann Bone Level Abutment

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 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 partially or completely edentulous patients. The abutment screw is intended to secure the crown abutment to the endosseous implant.

Atlantis™ Straumann Bone Level Abutment in Zirconia is compatible with the Ø3.3 mm Straumann Bone Level Implant.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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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Date: 2013.05.01 07:14:50-04'00'

Division Slan-Offi Division of Anesthestology, General Hospital Infection Control, Dental Devices

KI 5071 510(k) Number: