(107 days)
Not Found
No
The document describes a physical dental abutment and its materials, with no mention of software, algorithms, or AI/ML terms.
No.
This device is an abutment for dental implants, which supports a prosthetic device. It is a component of a dental restoration system, not a therapeutic device designed for treating a disease or condition.
No
Explanation: The device is described as an abutment intended to support a prosthetic device on a dental implant. Its function is mechanical support for a restoration, not to diagnose any condition or disease.
No
The device description clearly states the device is an abutment made of titanium and zirconia, which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for supporting a prosthetic device in a patient. This is a direct medical intervention on a patient's body.
- Device Description: The description details the materials and placement of the abutment within a dental implant. This is a physical device used in a surgical/dental procedure.
- 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 outside the body to analyze biological samples. This device is implanted within the body.
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 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 Straumann Implants: Standard SLActive 3.3mm, 4.1mm and 4.8mm and the Straumann Narrow Neck 3.5mm
The abutments in zirconia are compatible with the Straumann Implants: SLActive 4.1mm and 4.8mm.
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 restorations. The Atlantis™ Straumann Bone Level Abutment and abutment screw are made from Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136) for the 3.3mm, 4.1mm and 4.8mm sizes. In addition, the Atlantis™ Straumann Bone Level Abutment for the 4.1mm and 4.8mm sizes, also are made of the biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) (meets ISO Standards 6072 & 13356). The titanium and the zirconium abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.
The titianium abutments are compatible with Struamann Implants: Standard SLActive 3.3mm, 4.1mm and 4.8mm; and the Straumann Narrow Neck 3.5mm.
The abutments in zirconia are compatible with Straumann Implants: SLActive 4.1mm and 4.8mm
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K053088, K062129, K060958, K050052, K052070
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
Pre-market Notification Page - 000009
.. - - - - - - - - - - - - -
APR 1 5 2009
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.
1. Applicant's Name and Address
Astra Tech Inc. 25 First Street Cambridge, Massachusetts 02141 Telephone Number: 617-871-2783 Fax Number: 617-871-6607 Contact Person: Franklin Uyleman Manager of Quality and Regulatory Affairs
2. Name of Device
Trade Name: Atlantis™ Straumann Bone Level Abutment Common Name: Endosseous dental implant abutment Classification Name: Endosseous dental implant abutment 21 CFR 872.3630 Product code NHA
Legally Marketed Device to which Equivalence is claimed (Predicate Device) 3.
| Manufacturer | Device | 510(k)
Number |
|------------------------------------------------------------|------------------------------------------------|------------------|
| Institut Straumann AG | SLactive Implants | K053088 |
| Institut Straumann AG | P.0004 Implants | K062129 |
| Institut Straumann AG | Straumann Narrow Neck | K060958 |
| Atlantis Components
Inc. (currently Astra
Tech Inc.) | AtlantisTM Abutment for Straumann
Interface | K050052 |
| Atlantis Components
Inc. (currently Astra
Tech Inc.) | AtlantisTM Abutment in Zirconia | K052070 |
1
KOE3871
Pre-market Page - 000010 - - - - - - - - - - - - - - -
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 restorations. The Atlantis™ Straumann Bone Level Abutment and abutment screw are made from Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136) for the 3.3mm, 4.1mm and 4.8mm sizes. In addition, the Atlantis™ Straumann Bone Level Abutment for the 4.1mm and 4.8mm sizes, also are made of the biocompatible material, yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) (meets ISO Standards 6072 & 13356). The titanium and the zirconium abutments are placed over the implant shoulder and are mounted into the implant with a titanium screw.
The titianium abutments are compatible with Struamann Implants: Standard SLActive 3.3mm, 4.1mm and 4.8mm; and the Straumann Narrow Neck 3.5mm.
The abutments in zirconia are compatible with Straumann Implants: SLActive 4.1mm and 4.8mm
5. Intended Use of the Device
The devices covered by this submission are abutments which are placed into a dental implant to provide support for a prosthetic reconstruction. 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 retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.
6. Basis for Substantial Equivalence
The Atlantis™ Straumann Bone Level Abutments in titanium are substantially equivalent in intended use, material, design and performance to the Straumann SLActive abutments cleared under K053088, K062129, and K060958, as well as the Atlantis Abutments for Straumann Interface cleared under K050052. Also, the Atlantis™ Straumann Bone Level Abutments in zirconium are substantially equivalent in intended use, material, design and performance to the Atlantis™ Abutments in Zirconium cleared under K052070.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is presented in black and white, giving it a formal and official appearance.
Public Health Service
APR 1 5 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Astra Tech Incorporated C/o Ms. Betsy A. Brown B.A. Brown & Associates 8944 Tamaroa Terrace Skokie, Illinois 60076
Re: K083871
Trade/Device Name: Atlantis™ Straumann Bone Level Abutment Regulation Number: 21 CFR 872.3630 Regulatory Class: II Product Code: NHA Dated: April 10, 2009 Received: April 13, 2009
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 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.
3
Page 2- Ms. Brown
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Renner
Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Pre-market Notification Page - 000227
Indications for Use
KO83871 510(k) Number (if Known)
Device Name: Atlantis TM Straumann Bone Level Abutment
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 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 Straumann Implants: Standard SLActive 3.3mm, 4.1mm and 4.8mm and the Straumann Narrow Neck 3.5mm
The abutments in zirconia are compatible with the Straumann Implants: SLActive 4.1mm and 4.8mm.
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 (Part 21 CFR 801 SubpartD)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Signature Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K96-3571 |