(164 days)
Not Found
No
The summary describes dental implants and associated components made of titanium, with no mention of software, algorithms, or any terms related to AI or ML.
Yes
This device is an implant system used in dental patients, which falls under the definition of a therapeutic device designed to treat or alleviate a condition.
No
The provided text describes the device as a "Single Tooth Implant System" with "fixtures, abutments and other components" for "edentulous and partially edentulous arches," indicating it is a dental implant system used for treatment, not diagnosis. There is no mention of diagnostic functions.
No
The device description explicitly mentions "fixtures, abutments and other components" and "implants are root-form uncoated screws and are made from commercially pure titanium," indicating physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use describes the device for use in selected fully and partially edentulous arches. This relates to the treatment of patients with missing teeth, which is a clinical application within the body, not an in vitro diagnostic test performed on samples outside the body.
- Device Description: The description details components for dental implants, fixtures, and abutments made from titanium. These are physical devices implanted into the jawbone, not reagents or instruments used to analyze biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory tests.
Therefore, this device falls under the category of a dental implant system, which is a medical device used for surgical implantation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For use in selected fully edentulous and partially edentulous arches
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The additional components provided for by this 510(k) added to the fixtures, abutments and other components necessary to meet various clinical situations in partially and totally edentulous patients. All implants are root-form uncoated screws and are made from commercially pure titanium. The indications and uses for these additional components are not different from similar components of the predicate device. The application also provides for the use of the Single Tooth Implant System in multiple construction clinical situations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
edentulous 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
JUL 15 1999
510(k) SUMMARY Astra Tech Implants Dental System Additional Components
Submitters Information
Astra Tech, Inc. 430 Bedford Street, Suite 100 Lexington, MA 02173 781-861-7707 Contact: Mr. Niklas Lidskog
Date Prepared
January 12, 1999
Name of Device
Astra Tech Implants - Dental System Additional Abutments and Fixtures for Single Tooth Implant and Standard Implant
Classification Name
Endosseous Implant
Predicate Devices
Similar Devices Previously Approved Under K931767 - Astra Tech Implants - Dental System
Description of Device and Intended Use
The additional components provided for by this 510(k) added to the fixtures, abutments and other components necessary to meet various clinical situations in partially and totally edentulous patients. All implants are root-form uncoated screws and are made from commercially pure titanium. The indications and uses for these additional components are not different from similar components of the predicate device. The application also provides for the use of the Single Tooth Implant System in multiple construction clinical situations.
1
List of Components
| Product | Diameter | Part Number |
|---|---|---|
| Uni Abutment | Ultrashort, 20 mm | 22388 |
| Uni Abutment | Ultrashort, 45 mm | 22389 |
| Healing Abutment ST | Short | 22586 |
| Healing Abutment ST | Intermediate | 22589 |
| Abutment Screw ST | Short | 22554 |
| Uni Abutment ST | 20, 0.0 mm Cuff | 22674 |
| Uni Abutment ST | 20, 1.5 mm Cuff | 22675 |
| Uni Abutment ST | 20, 3.0 mm Cuff | 22676 |
| Uni Abutment ST | 20, 4.5 mm Cuff | 22677 |
| Uni Abutment ST | 20, 6.0 mm Cuff | 22678 |
| Uni Abutment ST | 45, 0.0 mm Cuff | 22694 |
| Uni Abutment ST | 45, 1.5 mm Cuff | 22695 |
| Uni Abutment ST | 45, 3.0 mm Cuff | 22696 |
| Uni Abutment ST | 45, 4.5 mm Cuff | 22697 |
| Uni Abutment ST | 45, 6.0 mm Cuff | 22698 |
| Fixture ST | 5.0 mm x 9 mm | 22821 |
| Fixture ST | 5.0 mm x 11 mm | 22822 |
| Fixture ST | 5.0 mm x 13 mm | 22823 |
| Fixture ST | 5.0 mm x 15 mm | 22824 |
| Fixture ST | 5.0 mm x 17 mm | 22825 |
| Fixture ST | 5.0 mm x 19 mm | 22826 |
| Fixture ST | 3.5/4.5, 9 mm | 22209 |
| Fixture ST | 3.5/4.5, 9 mm | 22212 |
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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 caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 15 1999
Mr. Niklas Lidskog Astra Tech, Incorporated 430 Bedford Street, Suite 100 Lexington, Massachusetts 02173
Re : K990304 Modification To Astra Tech Implants - Dental Trade Name: System Regulatory Class: III Product Code: DZE Dated: May 13, 1999 Received: May 17, 1999
Dear Mr. Lidskog:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Lidskog
this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Not Known 1990304 510(k) Number (if known): Astra Tech Implants - Dental System Device Name: For use in selected fully edentulous and partially Indications for Use: edentulous arches
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Line V (Per 21 CFR 801.1091
or
Over-The-Counter Use
(Optional Format 1-2-9G)
Susan Purrs
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices () { } 510(k) Number _