(106 days)
K#080156,K#071946
K#080156, K#071946
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 a dental implant, which supports a prosthetic device. It does not treat or cure a disease or condition, but rather functions to support a restoration.
No
The device description clearly states its purpose is to "support a prosthetic device" or "provide support for a prosthetic restoration." There is no mention of it being used to diagnose conditions or diseases.
No
The device description clearly states that the device is an abutment made of zirconia and a screw made of titanium, which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Atlantis Abutment is a dental device intended to be placed into a dental implant within a patient's mouth to support a prosthetic device. It is a physical component used in a surgical and restorative procedure.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze any biological specimens taken from the patient.
Therefore, the Atlantis Abutment falls under the category of a medical device, specifically a dental prosthetic component, rather than an In Vitro Diagnostic.
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 is compatible with the Astra Tech Osseospeed TX Profile 4.5, 5.0 and 5.0 S 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
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 Osseospeed TX Profile Implant for the Astra Tech Osseospeed Profile 4.5, 5.0 and 5.0 S Implants is made of biocompatible material, yttria-stabilized tetragonal for the zirconia polycrystals (Y-TZP) ( meets ISO Standards 6972 & 1356). 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
Not Found
Input Imaging Modality
Not Found
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Static and fatigue compression testing was conducted on "worst case scenario" implant Stand the susing Atlantis angled zirconia abutments with the Astra Tech Osseospeed TX Profile implant. Test results demonstrated that the Atlantis Abutments are compatible with the Astra Tech Osseospeed TX Profile implants and the implant system supported appropriate static and fatigue test loads demonstrating that the implant system performs as intended.
Key Metrics
Not Found
Predicate Device(s)
K#080156, K#071946
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
APR - 8 2011
5. 510(k) Summary
1
Premarket Notification Section 5: Page - 4
APR - 8 2011
510(k) Summary
Astra Tech Inc. Atlantis™ Abutment in Zirconia for Osseospeed TX Profile Implant
ADMINISTRATIVE INFORMATION
December 20, 2010 510K Summary preparation date: Astra Tech Inc. Manufacturer Name: 590 Lincoln Street Waltham, Massachusetts 02541 Telephone: 781-810-6462 781-810-6719 Fax: ' Official Contact: Franklin Uyleman
Betsy A Brown - --------------------------------------------------------------------------------------------------------------------------------------------------------------B.A. Brown and Associates Inc. Telephone: 847-560-4406 847-677-0177 Fax:
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | Atlantis™ Abutment in Zirconia for Osseospeed TX
Profile Implant |
|-------------------------|---------------------------------------------------------------------|
| Common Name: | Endosseous dental implant abutment
21 CFR 872.3630 |
| Product Code: | NHA |
| Classification Panel: | Dental Products 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 is compatible with the Astra Tech Osseospeed TX Profile 4.5, 5.0 and 5.0 S Implants.
2
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 Osseospeed TX Profile Implant for the Astra Tech Osseospeed Profile 4.5, 5.0 and 5.0 S Implants is made of biocompatible material, yttria-stabilized tetragonal for the zirconia polycrystals (Y-TZP) ( meets SO Standards 6972 & 1356). Zircomia may have variation in shade. The abutment serew 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 Osseospeed TX Profile Implant is substantially equivalent in indication and design principles to Astra Tech's Osseospeed TX Profile Implant cleared under K#080156 and The Atlantis Abutment in Zirconia for Astra Implants cleared under K#071946 which has been determined by FDA to be substantially equivalent to preamendment devices.
3
Premarket Notification Section 5: Page - 6
| Table 1: Substantial Equivalence Summary | ||
|---|---|---|
| Technological | ||
| Characteristics | Atlantis™ Abutment in | |
| Zirconia for Osseospeed TX | ||
| Profile Implant | Astra Tech Osseospeed | |
| Profile Implant TX System | ||
| Material | -Biocompatible ceramic | |
| material | -comparable compatible | |
| titanium grade Ti-6A-4V ELI | ||
| material | ||
| Performance characteristics | Allows the prosthesis to be | |
| cemented or screw retained to | ||
| abutment. While the abutment | ||
| screw is intended to secure the | ||
| abutment to the endosseous | ||
| implant. | Allows the prosthesis to be | |
| cemented or screw retained to | ||
| abutment. While the abutment | ||
| screw is intended to secure the | ||
| abutment to the endosseous | ||
| implant. | ||
| Intended Use | Intended for use with an: | |
| endosseous implant to support | ||
| a prosthetic device in a | ||
| partially or completely | ||
| edentulous patient. Intended | ||
| for use to support single or | ||
| multiple tooth prosthesis, in | ||
| mandible or maxilla. | Intended for use with an | |
| endosseous implant to support | ||
| a prosthetic device in a | ||
| partially or completely | ||
| edentulous patient. Intended | ||
| for use to support single or | ||
| multiple tooth prosthesis, in | ||
| mandible or maxilla. |
Toble 1 : Substantial Fanivalence Summa
Summary of Non-clinical Testing
Static and fatigue compression testing was conducted on "worst case scenario" implant Stand the susing Atlantis angled zirconia abutments with the Astra Tech Osseospeed TX Profile implant. Test results demonstrated that the Atlantis Abutments are compatible with the Astra Tech Osseospeed TX Profile 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 in Zirconia for Osseospeed TX Profile Implant is substantially equivalent to Astra Tech's Osseospeed TX Profile System (K080156) and the Atlantis Abutment in Zirconia for Astra Implant (K071946) predicate devices based on noted similarities in in Licount 101 rated informaterial, generated design principle and performance characteristics data.
4
Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Astra Tech. Incorporated C/O Ms. Betsy Brown Regulatory Consultant B.A. Brown & Associates 8944 Tamaroa Terrace Skokie, Illinois 60076
APR - 8 2011
Re: K103759
Trade/Device Name: Atlantis™ Abutment in Zirconia for Osseospeed TX Profile Implant Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: March 21, 2011 Received: March 23, 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.
5
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 vours.
ph foc
Anthony 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
6
Premarket Notification Section 4: Page - 3
Indications for Use
510(k) Number (if known) K ( 0 3 75 9
Device Name: Atlantis™ Abutment in Zirconia for Osseospeed TX Profile Implant
Indication for Use: .
The Atlantis Abutment is intended for use with an endosseous implant to support a prostheticdevice 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 is compatible with the Astra Tech Osseospeed TX Profile 4.5, 5.0 and 5.0 S 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Paine
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control and Dental Devices
510(k) Number: K103259