ATLANTIS ABUTMENT FOR CAMLOG IMPLANT, DUPLICATE ABUTMENT, LATER ABUTMENT
Device Facts
| Record ID | K110640 |
|---|---|
| Device Name | ATLANTIS ABUTMENT FOR CAMLOG IMPLANT, DUPLICATE ABUTMENT, LATER ABUTMENT |
| Applicant | Astra Tech, Inc. |
| Product Code | NHA · Dental |
| Decision Date | Jun 10, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3630 |
| Device Class | Class 2 |
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. This device is compatible with the following manufacturers' implant systems: The titanium abutments are compatible with the Camlog 3.3mm, 4.3mm, 5.0mm, 5.0mm and 6.0mm Root-Line, Cylinder-Line, Cylinder Line TPS, Screw-Line, Promote and Promote Plus K-Series Implants. The zirconia abutments are compatible with the Camlog 3.8mm, 5.0mm and 6.0mm Root-Line, Cylinder-Line, Cylinder Line TPS, Screw-Line, Promote and Promote Plus K-Series Implants. Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional. Highly angled abutments on small diameter implants are intended for the anterior region only.
Device Story
Atlantis Abutment provides interface between endosseous dental implant and prosthetic restoration; supports single/multiple tooth prostheses via cement or screw retention. Device consists of abutment and titanium screw; fabricated from Titanium alloy (Ti-6Al-4V ELI) or yttria-stabilized tetragonal zirconia polycrystals (Y-TZP). Placed by dental professionals in clinical settings; secures to implant shoulder. Provides structural support for dental prosthetics; enables functional restoration of edentulous sites. Compatibility varies by material and specific Camlog implant system dimensions.
Clinical Evidence
Bench testing only. Static and fatigue compression testing performed on worst-case implant assemblies using angled titanium and zirconia abutments with Camlog implants. Results demonstrated compatibility and that the system supports appropriate loads.
Technological Characteristics
Materials: Titanium alloy (ASTM F-136) and yttria-stabilized tetragonal zirconia polycrystals (ISO 6972 & 13356). Form factor: Custom abutment for endosseous dental implants. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.
Indications for Use
Indicated for partially or completely edentulous patients requiring single or multiple tooth prosthetic support in the mandible or maxilla via endosseous dental implants. Highly angled abutments on small diameter implants restricted to anterior region.
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
Submission Summary (Full Text)
{0}------------------------------------------------
K110640
JUN 1 0 2011
Premarket Notification Section 5: Page - 4
#### 510(k) Summary
### Astra Tech Inc. Atlantis™ Abutment for Camlog Implant
# ADMINISTRATIVE INFORMATION
| 510K Summary preparation date: | Februaury 1, 2011 |
|--------------------------------|-----------------------------------------------------------------------|
| Manufacturer Name: | Astra Tech Inc.<br>590 Lincoln Street<br>Waltham, Massachusetts 02541 |
| Telephone: | 781-810-6462 |
| Fax: | 781-810-6719 |
| Official Contact: | Franklin Uyleman |
| Representative/Consultant: | Betsy A. Brown |
Betsy A. Brown B.A. Brown and Associates Inc. Telephone: 847-560-4406 847-677-0177 Fax:
#### DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: Common Name:
Product Code: Classification Panel: Reviewing Branch:
Atlantis™ Abutment for Camlog Implant Endosseous dental implant abutment 21 CFR 872.3630 NHA Dental Products Panel Dental Devices Branch
#### 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.
{1}------------------------------------------------
Premarket Notification Section 5: Page - 5
## INTENDED USE (continued)
This device is compatible with the following manufacturers' implant systems:
The titanium abutments are compatible with the Camlog 3.3mm, 4.3mm, 5.0mm, 5.0mm and 6.0mm Root-Line, Cylinder-Line, Cylinder Line TPS, Screw-Line, Promote and Promote Plus K-Series Implants.
The zirconia abutments are compatible with the Camlog 3.8mm, 5.0mm and 6.0mm Root-Line, Cylinder-Line, Cylinder Line TPS, Screw-Line, Promote and Promote Plus K-Series Implants.
Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.
Highly angled abutments on small diameter implants are intended for the anterior region only.
#### DEVICE DESCRIPTION
The devices covered in this submission are abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented or screw retained restorations. The Atlantis™ Abutment for Camlog Implant and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136) for the 3.3mm. 3.8mm. 4.3mm. 5.0mm and 6.0mm sizes. In addition. the Atlantis™ Abutment for Camlog Implant for the 3.8mm. 4.3mm. 5.0mm and 6.0mm sizes are also made of biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y -TZP) and meets ISO Standards 6972 & 13356). Zirconia may have variation in shade. The titanium and zirconia abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.
### EQUIVALENCE TO MARKETED DEVICE
Astra Tech Inc. demonstrated that, for purposes of the FDA's regulations of medical devices, the Atlantis™ Abutment for Camlog Implant is substantially equivalent in indications and design principles to Altatec GmbH predicate devices: Screwline Implant cleared under K022425. Cylinder Implant cleared under K000065 and Rootform Implant cleared under K000100 each of which has been determined by FDA to be substantially equivalent to preamendment devices.
{2}------------------------------------------------
Premarket Notification Section 5: Page - 6
| Technological<br>Characteristics | Atlantis™ Abutment for<br>Camlog Implant | Altatec Screwline,Cylinder<br>and Rootform Implants |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | -Titanium Alloy<br>-Biocompatible ceramic<br>material | -Titanium Alloy |
| Performance characteristics | Allows the prosthesis to be<br>cemented or screw retained to<br>abutment. While the abutment<br>screw is intended to secure the<br>abutment to the endosseous<br>implant. | Allows the prosthesis to be<br>cemented or screw retained to<br>abutment. While the abutment<br>screw is intended to secure the<br>abutment to the endosseous<br>implant. |
| Intended Use | Intended for use with an<br>endosseous implant to support<br>a prosthetic device in a<br>partially or completely<br>endentulous patient. Intended<br>for use to support single or<br>multiple tooth prosthesis, in<br>mandible or maxilla. | Intended for use with an<br>endosseous implant to support<br>a prosthetic device in a<br>partially or completely<br>endentulous patient. Intended<br>for use to support single or<br>multiple tooth prosthesis, in<br>mandible or maxilla. |
### Table 1: Substantial Equivalence Summary
# Summary of Non-clinical Testing
Static and fatigue compression testing was conducted on "worst case scenario" implant assemblies using Atlantis angled titanium and zirconia abutments with the Camlog implants. Test results demonstrated that the Atlantis Abutments are compatible with the Camlog implants and the implant system supported appropriate static and fatigue test loads demonstrating that the implant system performs as intended.
# Conclusion for Substantial Equivalence:
The Atlantis™ Abutment for Camlog Implant is substantially equivalent to Altatec's predicate devices: : Screwline Implant cleared under K022425, Cylinder Implant cleared under K000065 and Rootform Implant cleared under K000100, based on noted similarities in indication, manufacturing material, generated design principle and performance characteristics data.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected, flowing lines, possibly representing health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 1 0 2011
Astra Tech. Incorporated C/ O Ms. Betsy A. Brown Regulatory Consultant B.A. Brown & Associates 8944 Tamaroa Terrace Skokie, Illinois 60076
Re: K110640
Trade/Device Name: AtlantisTM Abutment for Camlog Implant Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 3, 2011 Received: June 8, 2011
Dear Ms. Brown:
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.
{4}------------------------------------------------
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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Th for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Premarket Notification Section 4: Page - 3
#### Indications for Use
510(k) Number (if known)_
Device Name: Atlantis™ Abutment for Camlog Implant
Indication 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.
This device is compatible with the following manufacturers' implant systems:
The titanium abutments are compatible with the Camlog 3.3mm, 4.3mm, 5.0mm and 6.0mm Root-Line, Cylinder-Line, Cylinder Line TPS, Screw-Line, Promote and Promote Plus K-Series Implants.
The zirconia abutments are compatible with the Camlog 3.8mm. 5.0mm and 6.0mm Root-Line, Cylinder-Line, Cylinder Line TPS, Screw-Line, Promote and Promote Plus K-Series Implants.
Please note: This device may be used in an early load situation, but is dependent on the specific implant system and protocol used by the dental professional.
Highly angled abutments on small diameter implants are intended for the anterior region only.
Prescription Use X (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)
510(k) Number:
(Division Sigm-Uff) Division of Anesthesiology, General Hospital infection Control, Dental Devices
