(128 days)
Not Found
No
The summary describes a physical dental abutment and its materials, with no mention of software, algorithms, or any AI/ML related terms or concepts.
No
The device is an abutment for dental implants designed to support a prosthetic device, not to treat a disease or condition itself.
No
The document describes the Atlantis Abutment as a device that supports prosthetic teeth. Its intended use and device description focus on its mechanical function and materials, with no mention of diagnosing conditions or diseases.
No
The device description explicitly states the device is an "abutment" made from physical materials (Titanium and Zirconia) and is placed into a dental implant. This is a physical medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states the device is an "abutment which is placed into the dental implant to provide support for a prosthetic restoration." Its intended use is to support prosthetic devices in the mouth of a patient.
- No Mention of Testing or Samples: There is no mention of the device being used to test samples or provide diagnostic information.
The device is a dental implant component, which is a type of medical device, but not an IVD.
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 cement 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 Dentsply 3.0mm, 3.8mm, 4.5mm and 5.5mm XiVE® S Plus Implants.
The titanium and zirconia abutments are compatible with the Dentsply 3.4mm, 3.8mm, 4.5mm, 5.5mm and 6.5mm Frialit® Plus Implants.
The zirconia abutments are compatible with Dentsply 3.4mm, 4.5mm and 5.5mm XiVE® S Plus 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 (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.
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 Dentsply Implant and abutment screw are made from Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136) for the 3.0mm, 3.4mm, 3.8mm, 4.5mm, 5.5mm and 6.5mm sizes. In addition, the Atlantis™ Abutment for Dentsply Implant for the 3.4mm, 3.8mm, 5.5mm and 6.5mm sizes, also are made of the biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y -TZP) (meets ISO Standards 6072 & 13356). Zirconia may have a variation in shade. The titanium and the zirconium 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, posterior 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
Attachment #1
VII. SECTION 10 - 510(K) SUMMARY
This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR Part 807.92.
Date of Summary preparation: December 9, 2009
1. Applicant's Name and_Address
Astra Tech Inc.
590 Lincoln Street
Waltham, Massachusetts 02451
Telephone Number: 781-810-6462
Fax Number: 781-810-6719
Contact Person:
Manager of Quality and Regulatory Affairs
2. Name of Device
| Trade Name: | Atlantis™ Abutment for Dentsply Implant |
|---|---|
| Common Name: | Endosseous dental implant abutment |
| Classification Name: | Endosseous dental implant abutment |
| 21 CFR 872.3630 Product code NHA |
Franklin Uyleman
1
Legally Marketed Device to which Equivalence is claimed (Predicate Device) 3.
| Manufacturer | Device | 510(k)
Number |
|-------------------------------------------------------|------------------------------------------------------|------------------|
| Dentsply International,
Inc. | Frialit Plus, XIVE ® S Plus Dental
Implant System | K073075 |
| Atlantis Components
Inc. (currently Astra
Tech) | Atlantis Abutment in Zirconia | K052070 |
4. Description of the Device
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 Dentsply Implant and abutment screw are made from Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136) for the 3.0mm, 3.4mm, 3.8mm, 4.5mm, 5.5mm and 6.5mm sizes. In addition, the Atlantis™ Abutment for Dentsply Implant for the 3.4mm, 3.8mm, 5.5mm and 6.5mm sizes, also are made of the biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y -TZP) (meets ISO Standards 6072 & 13356). Zirconia may have a variation in shade. The titanium and the zirconium abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.
న. Intended Use of the Device
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 cement or screw retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
2
5. Intended Use of Device (continued):
This device is compatible with the following manufacturers' implant systems:
The titanium abutments are compatible with the Dentsply 3.0mm, 3.8mm, 4.5mm and 5.5mm XiVE® S Plus Implants.
The titanium and zirconia abutments are compatible with the Dentsply 3.4mm, 3.8mm, 4.5mm, 5.5mm and 6.5mm Frialit® Plus Implants.
The zirconia abutments are compatible with Dentsply 3.8mm, 4.5mm and 5.5mm XiVE® S Plus 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 (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.
Basis for Substantial Equivalence Q.
The Atlantis™ Abutments for Dentsply Implants are substantially equivalent in intended use, material, design and performance to the Dentsply Frialit Plus, XIVE S Plus Dental Implant System cleared under K073075 and the Atlantis Components Inc. (currently, Astra Tech) Zirconia Abutment cleared under K052070.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with stylized wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 1 $ 2010
Astra Tech, Incorporated C/O Ms. Betsy A Brown Consultant B.A. Brown & Associates 8944 Tamaroa Terrace Skokie, Illinois 60076
Re: K093780
Trade/Device Name: Atlantis™ Abutment for Dentsply Implant Regulation Number: 21CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: March 29, 2010 Received: March 30, 2010
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
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/ucm1 | 5809.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.
Wh 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
Pre-market Notification Page - 000227
Indications for Use
510(k) Number (if Known)_109 3780
Device Name: Atlantis TM Abutment for Dentsply 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 cement 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 Dentsply 3.0mm, 3.8mm, 4.5mm and 5.5mm XiVE® S Plus Implants.
The titanium and zirconia abutments are compatible with the Dentsply 3.4mm, 3.8mm, 4.5mm, 5.5mm and 6.5mm Frialit@ Plus Implants.
The zirconia abutments are compatible with Dentsply 3.4mm, 4.5mm and 5.5mm XiVE® S Plus 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 (i.e. 30 degrees) on implants with diameters less than 4 mm are intended for the anterior region of the mouth and are not intended for the posterior region due to limited strength of the implant.
Prescription Use X (Part 21 CFR 801 SubpartD)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Asetz DDS for | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|---|
| (Division Sign-Off) | |
| Division of Anesthesiology General Hospital |
lestology, General Hospital Infection Control, Dental Devices
510(k) Number: K093780