(128 days)
K#111287, K#071946
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No
The document describes a dental abutment and its materials, intended use, and performance testing. There is no mention of AI or ML technology.
No.
This device is an abutment for dental implants, which supports a prosthetic device. It is a structural component of a dental restoration rather than a device designed to directly treat a disease or condition.
No
This device is an abutment, intended to support a prosthetic device in edentulous patients. It is a restorative component, not a diagnostic tool.
No
The device description explicitly states the device is an abutment made of physical materials (zirconia and titanium) and is placed into a dental implant. This indicates it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an abutment used with an endosseous implant to support a prosthetic device in a patient. This is a surgical/dental device used in vivo (within the body).
- Device Description: The description details the materials and placement of the abutment within the dental implant. This further confirms its use as an implant component.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a physical component implanted within the patient's mouth.
N/A
Intended Use / 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 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Implant is compatible with the Astra Tech Osseospeed Plus 3.6mm and 4.2mm 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 angulated abutments on small implants are intended for the anterior region of the mouth only.
Product codes (comma separated list FDA assigned to the subject device)
NHA
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 in Zirconia for Astra Tech Osseospeed Plus Implant for the Astra Tech Osseospeed Plus 3.6mm and 4.2mm Implants is made of biocompatible material, yttria-stabilized tetragonal for the zirconia polycrystals (Y-TZP) ( meets ISO Standards 6972 & 13356). Zirconia may have variation in shade. The abutment screw is made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). The zirconia abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
mandible or maxilla
anterior region of the mouth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professional
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Static and fatigue compression testing was conducted on "worst case scenario" implant assemblies using Atlantis angled zirconia abutments with the Astra Tech Osseospeed Plus Implant. Test results demonstrated that the Atlantis Abutments are compatible with the Astra Tech Osseospeed Plus Implant and the implant system supported appropriate static and fatigue test loads demonstrating that the implant system performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K#111287, K#071946
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.)
0
112138
@EC - 1 2011
Premarket Notification Section 5: Page - 4
510(k) Summary
Astra Tech Inc. Atlantis™ Abutment in Zirconia for Astra Tech Osseospeed Plus Implant
ADMINISTRATIVE INFORMATION
| 510K Summary preparation date: | July 13, 2011 |
|---|---|
| Manufacturer Name: | Astra Tech Inc. |
| 590 Lincoln Street | |
| Waltham, Massachusetts 02541 | |
| Telephone: 781-810-6462 | |
| Fax: 781-810-6719 | |
| Official Contact: | Franklin Uyleman |
| Representative/Consultant: | Betsy A. Brown |
| B.A. Brown and Associates Inc. | |
| Telephone: 847-560-4406 | |
| Fax: 847-677-0177 |
DEVICE NAME AND CLASSIFICATION
Atlantis™ Abutment in Zirconia for Astra Tech Trade/Proprietary Name: Osseospeed Plus Implant Common Name: Endosseous dental implant abutment 21 CFR 872.3630 Product Code: NHA Dental Products Panel Classification Panel: Reviewing Branch: 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.
This device is compatible with the following manufacturers' implant systems: The Atlantis Abutment in Zirconia for Astra Tech Osseospeed Implant is compatible with the Astra Tech Osseospeed Plus 3.6mm and 4.2mm Implants.
1
Premarket Notification Section 5: Page - 5
INTENDED USE (continued)
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 angulated abutments on small implants are intended for the anterior region of the mouth 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 in Zirconia for Astra Tech Osseospeed Plus Implant for the Astra Tech Osseospeed Plus 3.6mm and 4.2mm Implants is made of biocompatible material, yttria-stabilized tetragonal for the zirconia polycrystals (Y-TZP) ( meets ISO Standards 6972 & 13356). Zirconia may have variation in shade. The abutment screw is made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). The 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 in Zirconia for Astra Tech Osseospeed Plus Implant is substantially equivalent in indication and design principles to the abutment in Astra Tech's Implant System K#111287 and the Atlantis™ Abutment in Zirconia for Astra Implants K#071946 which has been determined by FDA to be substantially equivalent to preamendment devices.
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Premarket Notification Section 5: Page - 7
Summary of Non-clinical Testing
Static and fatigue compression testing was conducted on "worst case scenario" implant assemblies using Atlantis angled zirconia abutments with the Astra Tech Osseospeed Plus Implant. Test results demonstrated that the Atlantis Abutments are compatible with the Astra Tech Osseospeed Plus Implant 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 in Zirconia for Astra Tech Osseospeed Plus Implant is substantially equivalent to Astra Tech's Implant System (Osseospeed) K#111287 and the Atlantis™ Abutment in Zirconia for Astra Implants cleared under K#071946 predicate devices, based on noted similarities in indication, manufacturing material, generated design principle and performance characteristics data.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three swooping lines representing its wings. To the left of the eagle is a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Astra Technology, Incorporated C/O Ms. Betsy A. Brown Consultant B.A. Brown & Associates 8944 Tamaroa Terrace Skokie, Illinois 60076
DEC - 1 2011
Re: K112138
Trade/Device Name: Atlantis™ Abutment in Zirconia for Astra Tech Osseospeed Plus Implant Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: November 16, 2011 Received: November 21, 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.
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Page 2 - Ms. Brown
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony D. Antain
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 :
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Premarket Notification Section 4: Page - 3
Indications for Use
510(k) Number (if known) K / |2 / 38
Device Name: Atlantis™ Abutment in Zirconia for Astra Tech Osseospeed Plus 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 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Implant is compatible with the Astra Tech Osseospeed Plus 3.6mm and 4.2mm 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 of the mouth 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) Super Circular
Concurrence of CDRH, Office of Device WalsiandighedfE)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: