(435 days)
No
The document describes a dental implant system with new abutment shapes and materials. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies.
No.
This device is an implant system used for supporting crowns, bridges, or overdentures, which functionally replaces missing teeth rather than directly treating a disease or condition.
No
The device is an implant system used for supporting crowns, bridges, or overdentures, not for diagnosing medical conditions.
No
The device description explicitly states it is a system of physical abutments made of titanium and zirconia, which are hardware components.
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 abutments are used in conjunction with an implant system to provide support for dental prosthetics (crowns, bridges, overdentures) within the patient's mouth. This is a direct therapeutic and restorative application within the body.
- Device Description: The description details the physical components and their function in connecting to the implant and supporting the dental prosthetics.
- 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 used inside the body as a component of a dental implant system.
N/A
Intended Use / Indications for Use
Astra Tech Implant System abutments are intended to be used in conjunction with the Astra Tech Implant System in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures. Highly angled abutments on small diameter implants are not recommended for use in the molar region. ZirDesign is not recommended for use in the molar regions.
Product codes
NHA
Device Description
The Astra Tech Implant System has been modified to increase treatment options by adding new abutment shapes in titanium and zirconia. Both abutment designs are provided in multiple sizes with straight and angled versions. The hex interlocking anti-rotation mechanism for indexing with the implant remains unchanged from the predicate devices. As with the predicate devices, Astra Tech's Conical Seal Design™ is used for the internal connection with the implant to achieve a tight and stable interface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary and/or mandibular arches
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Performance testing was provided to demonstrate substantial equivalence and included methods described in ISO 14801.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
510(k) Summary
/S3
Astra Tech AB Special 510(k): Device Modification K101005
JUN 2 1 2011
June 13, 2011
Astra Tech Implant System - New Components
ADMINISTRATIVE INFORMATION
Manufacturer Name:
Official Contact:
Representative/Consultant:
Astra Tech AB Aminogatan 1, P.O. Box 14 Mölndal, Sweden SE-431-21 Telephone: +46 31 776 30 00 Fax: +46 31 776 30 10
Christina Lewing
Linda K. Schulz or Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego. CA 92130 Telephone: +1 (858) 792-1235 Fax: +1 (858) 792-1236 Email: Ischulz@paxmed.com flarson@paxmed.com
DEVICE NAME AND CLASSIFICATION
Trade/Proprietary Name: Astra Tech Implant System, New Components Common Name: Endosseous dental implant abutment Classification Name: Abutment, Implant, Dental, Endosseous (21 CFR 872.3630), Class II Product Code: NHA Classification Panel: Dental Products Reviewing Branch: Dental Devices
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INTENDED USE
Astra Tech Implant System abutments are intended to be used in conjunction with the Astra Tech Implant System in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures. Highly angled abutments on small diameter implants are not recommended for use in the molar region. ZirDesign is not recommended for use in the molar regions.
DEVICE DESCRIPTION
The Astra Tech Implant System has been modified to increase treatment options by adding new abutment shapes in titanium and zirconia. Both abutment designs are provided in multiple sizes with straight and angled versions. The hex interlocking anti-rotation mechanism for indexing with the implant remains unchanged from the predicate devices. As with the predicate devices, Astra Tech's Conical Seal Design™ is used for the internal connection with the implant to achieve a tight and stable interface.
EQUIVALENCE TO MARKETED PRODUCT
K974738, K023631, K080396 - Astra Tech Implant System K070833, K071946 - Atlantis System
The subject device and the predicate devices have the same intended use and have the same technological characteristics. Both are made of the same materials. They encompass the same range of physical dimensions, including diameter and length of the implants, and diameter, height and angle of the abutments. The subject and predicate devices are packaged in similar materials and sterilized using similar methods. Any differences in the technological characteristics do not raise new issues of safety or efficacy.
Performance testing was provided to demonstrate substantial equivalence and included methods described in ISO 14801.
The modified Astra Tech Implant System has the following similarities to the unmodified predicate Astra Tech Implant System:
- · has the same intended use,
- · uses the same operating principle,
- · are made from the same materials,
- · incorporates the same basic design, and
- · is packaged using the same materials and processes.
In summary, the modification to the Astra Tech Implant System described in this submission is, in our opinion, substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Astra Tech AB C/O Ms. Linda K. Schulz Paxmed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130
JUN 2 1 2011
Re: K101005
Trade/Device Name: Astra Tech Implant System - New Component Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 13, 2011 Received: June 15, 2011
Dear Ms. Schulz:
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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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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Suarez
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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Indications for Use
K101005 510(k) Number:
Astra Tech Implant System - New Components Device Name:
Indications for Use:
Astra Tech Implant System abutments are intended to be used in conjunction with the Astra Tech Implant System in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures. Highly angled abutments on small diameter implants are not recommended for use in the molar region. ZirDesign is not recommended for use in the molar regions.
| 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)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K101005 |
|---|---|
| ---------------- | --------- |
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