(335 days)
Not Found
No
The document describes physical dental abutments and screws, with no mention of software, algorithms, or AI/ML capabilities.
Yes.
The device components assist in the construction of dental bridges for edentulous patients, which is a therapeutic intervention to restore dental function and aesthetics.
No
The device description and indications for use clearly describe the components as "prepable components" that are "placed in a fixture for cemented bridge construction" or "screws that are used to attach the Profile BiAbutment ST to the fixture." This indicates the device is a dental prosthetic system for reconstruction, not for diagnosis.
No
The device description and component list clearly indicate that this submission is for physical dental abutments and screws, which are hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use and indications clearly describe components used in dental procedures for placing and securing abutments for cemented bridge construction in edentulous and partially edentulous arches. This is a surgical/prosthetic application, not a diagnostic test performed on samples outside the body.
- Device Description: The device description further reinforces that these are components for prosthetic and laboratory procedures related to dental implants.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health condition.
The device is a dental implant component system.
N/A
Intended Use / Indications for Use
For use in selected fully edentulous and partially edentulous arches.
The following table describes the indication for use for each component listed as part of this 510(k) submission:
| Component | Part Number | Indication for Use |
|---|---|---|
| Profile UniAbutment 4.5 | 22852 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile UniAbutment 5.5 ultra | 22855 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile UniAbutment 5.5 | 22856 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile UniAbutment 7.0 | 22860 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile BiAbutment 4.5 | 22782 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile BiAbutment 5.5 ultra | 22785 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile BiAbutment 5.5 | 22786 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile BiAbutment 7.0 | 22790 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile BiAbutment ST 4.5 | 22870 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile BiAbutment ST 5.5 | 22872 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile BiAbutment ST 7.0 | 22874 | Prepable component that is placed in fixture for cemented bridge construction |
| Abutment Screw ST, short | 22554 | Screw that is used to attach the Profile BiAbutment ST to the fixture |
Product codes
DZE
Device Description
The Prepable Abutment System is comprised of a selection of components for prosthetic and laboratory procedures for single-tooth and multiple tooth constructions. The additional components provided for by this 510(k) are added to the fixtures, abutments and other components necessary to meet various clinical situations in partially and totally edentulous patients. All implants are made from commercially pure titanium. The indications and uses for these additional components are not different from similar components of the predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) SUMMARY Astra Tech Implants Dental System Additional Components
non 1 9 1208
Submitters Information
Astra Tech, Inc. 430 Bedford Street, Suite 100 Lexington, MA 02173 Contact: Mr. Niklas Lidskog
Date Prepared
December 16, 1997
Name of Device
Astra Tech Implants - Dental System Prepable Abutment System - ADDITIONAL COMPONENTS for single-tooth and multiple tooth constructions.
Classification Name
Endossous Implant
Predicate Devices
Similar Devices Previously Approved Under K931767 - Astra Tech Implants - Dental System (Abutment Screw ST, Healing Abutment, Angled Abutment Adapter) Steri-Oss Dental Implants - Esthetic Abutment System, Steri-Oss Implants Friction Drive Wrench, Try-In Kit
Description of Device and Intended Use
The Prepable Abutment System is comprised of a selection of components for prosthetic and laboratory procedures for single-tooth and multiple tooth constructions. The additional components provided for by this 510(k) are added to the fixtures, abutments and other components necessary to meet various clinical situations in partially and totally edentulous patients. All implants are made from commercially pure titanium. The indications and uses for these additional components are not different from similar components of the predicate device.
1
મેર
Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nov 1 9 1998
Mr. Niklas Lidskog President Astra Tech, Incorporated 430 Bedford Street, Suite 100 Lexington, Massachusetts 02173
Re : K974738 Astra Tech Implants - Dental System Trade Name: Requlatory Class: III Product Code: DZE Dated: September 22, 1998 Received: September 23, 1998
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 aqainst 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 requlations 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) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification 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.
2
Page 2 - Mr. Lidskog
This letter will allow you to begin marketing your device as first receir #110 million market notification. The FDA described in your sieth, provilence of your device to a legally finding of babbandarice results in a classification for your marketed predicator and the 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 regulation (stic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on Compriation 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.fdag.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
3
Image /page/3/Picture/0 description: The image shows a black and white logo. The logo consists of two triangles, one smaller than the other. The smaller triangle is positioned to the left of the larger triangle, and there is a white line separating the two triangles.
510(k) Number (if known): K974738 Device Name: ASTRA TECH IMPLANTS - DENTAL SYSTEM
Indications for Use:
For use in selected fully edentulous and partially edentulous arches.
The following table describes the indication for use for each component listed as part of this 510(k) submission:
| Component | Part
Number | Indication for Use |
|-------------------------------|----------------|-------------------------------------------------------------------------------|
| Profile UniAbutment 4.5 | 22852 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile UniAbutment 5.5 ultra | 22855 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile UniAbutment 5.5 | 22856 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile UniAbutment 7.0 | 22860 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile BiAbutment 4.5 | 22782 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile BiAbutment 5.5 ultra | 22785 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile BiAbutment 5.5 | 22786 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile BiAbutment 7.0 | 22790 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile BiAbutment ST 4.5 | 22870 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile BiAbutment ST 5.5 | 22872 | Prepable component that is placed in fixture for cemented bridge construction |
| Profile BiAbutment ST 7.0 | 22874 | Prepable component that is placed in fixture for cemented bridge construction |
| Abutment Screw ST, short | 22554 | Screw that is used to attach the Profile BiAbutment ST to the fixture |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Line | |
| (Per 21 CFR 801.1091) | |
| (Optional format 1-2-9G) | |
| or Over-the Counter Use | |
| (Division Sign-Off) | Susan Dater |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K974738 |