(114 days)
Not Found
No
The summary describes a physical dental abutment and its materials, with no mention of software, algorithms, or any terms related to AI/ML.
Yes
The device is described as an abutment intended for use with an endosseous implant to support a prosthetic device in partially or completely edentulous patients. Its function is to support single and multiple tooth prostheses. This directly implies a therapeutic purpose—restoring dental function and aesthetics for patients missing teeth.
No
Explanation: The device is an Atlantis Abutment intended to support a prosthetic device in a patient. Its purpose is to provide structural support for a prosthestic. It does not perform any diagnostic function.
No
The device description clearly states the device is a physical abutment made of titanium or zirconia, which is a hardware component.
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 function of a dental abutment, which is a physical component placed in the mouth.
- 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 screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a physical implant component used in vivo.
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 titanium abutments are compatible with the Keystone 3.5mm, 4.1mm and 5.0mm Keystone Implants.
The zirconia abutments are compatible with the Keystone 3.5mm, 4.1mm and 5.0mm Keystone 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.
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 for Keystone Implant and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136) for the 3.5mm, 4.0mm, 4.1mm and 5.0mm sizes. In addition, the Atlantis™ Abutment for Keystone Implant for the 3.5mm, 4.1mm and 5.0mm 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible or maxilla
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 (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 titanium and zirconia abutments with the Keystone implant. Test results demonstrated that the Atlantis Abutments are compatible with the Keystone implants 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)
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
FEB - 3 20il
510(k) Summary
Astra Tech Inc. Atlantis™ Abutment for Keystone Implant
ADMINISTRATIVE INFORMATION
510K Summary preparation date:
Manufacturer Name:
September 30, 2010
Astra Tech Inc. 590 Lincoln Street Waltham, Massachusetts 02541 Telephone: 781-810-6462 781-810-6719 Fax:
Official Contact:
Representative/Consultant:
Franklin Uyleman
Betsy A. Brown B.A. Brown and Associates Inc. Telephone: 847-560-4406 Fax: 847-677-0177
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: Atlantis™ Abutment for Keystone 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 titanium abutments are compatible with the Keystone 3.5mm, 4.1mm and 5.0mm Keystone Implants.
1
K103020
Premarket Notification Section 5: Page - 5
INTENDED USE (continued)
The zirconia abutments are compatible with the Keystone 3.5mm, 4.1mm and 5.0mm Keystone 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 Keystone Implant and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136) for the 3.5mm, 4.0mm, 4.1mm and 5.0mm sizes. In addition, the Atlantis™ Abutment for Keystone Implant for the 3.5mm, 4.1mm and 5.0mm 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 Keystone Implant is substantially equivalent in indications and design principles to Lifecore's predicate devices: PrimaConnex Internal Connection Implant System cleared under K051614 and PrimConnex Ceramic Abutments cleared under K062876, each of which has been determined by FDA to be substantially equivalent to preamendment devices.
2
Premarket Notification
Section 5: Page – 6
| Table 1: Substantial Equivalence Summary | ||
|---|---|---|
| Technological | ||
| Characteristics | Atlantis™ Abutment for | |
| Keystone Implant | Keystone Primaconnex | |
| Implant System | ||
| Material | -Titanium Alloy | |
| -Biocompatible ceramic | ||
| material | -Titanium Alloy | |
| -Biocompatible ceramic | ||
| 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 | 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 Keystone 3.5mm, 4.0mm, | ||
| 4.1mm and 5.0mm Keystone | ||
| Implants. The zirconia | ||
| abutments are compatible with | ||
| the Keystone 3.5mm, 4.0mm, | ||
| 4.1mm and 5.0mm Keystone | ||
| Implants. Please note: This | ||
| device may be used in an early | ||
| load situation, but is depend- | ||
| ent on the specific implant | ||
| system and protocol used by | ||
| the dental professional. | Intended for use with an | |
| endosseous implant to support | ||
| a prosthetic device in a | ||
| partially or completely | ||
| endentulous patient. Intended | ||
| for use to support single or | ||
| multiple tooth prosthesis, in | ||
| 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. | ||
| Highly angled abutments on | ||
| small diameter implants are | ||
| intended for the anterior | ||
| region only. |
Table 1: Substantial Equivalence Summary
3
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 Keystone implant. Test results demonstrated that the Atlantis Abutments are compatible with the Keystone 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 Keystone Implant is substantially equivalent to Lifecore's predicate devices: PrimaConnex Internal Connection Implant System cleared under K051614 and PrimConnex Ceramic Abutments cleared under K062876, based on noted similarities in indication, manufacturing material, generated design principle and performance characteristics data.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure, with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular fashion around the bird symbol.
Public Health Service
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 B.A. Brown & Associates 8944 Tamaroa Terrace Skokie, Illinois 60073
FEB - 3 201
Re: K103020
Trade/Device Name: Atlantis™ Abutment for Keystone Implant Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: January 26, 2011 Received: January 27, 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
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 (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 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/ReportalProblem/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,
h 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
6
Premarket Notification Section 4: Page - 3
- ... .
Indications for Use
510(k) Number (if known)_ K 103020
Device Name: AtlantisTM Abutment for Keystone 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 Keystone 3.5mm, 4.1mm and 5.0mm Keystone Implants.
The zirconia abutments are compatible with the Keystone 3.5mm, 4.1mm and 5.0mm Keystone 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 AND THER PAGE IF All see form NEEDED)
(Oivision of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Concurrence of CDRH, Office of Deffice of Departions (ODE) Division of Anesthoolor of Or
510(k) Number: _______________________________________________________________________________________________________________________________________________________________