(95 days)
Not Found
No
The device description and intended use focus on physical components for dental impressions and casting, with no mention of software, algorithms, or AI/ML capabilities.
No.
The device components are described as "restorative components which will allow impression taking from the fixture level and fabrication of a stone cast," used for replicating dental fixture positions for prosthetics, rather than for directly treating a disease or condition.
No
The device description and indications for use clearly state that these components are for restorative purposes, specifically for impression taking and fabricating models to aid in the placement of dental prosthetics. They do not diagnose conditions or diseases.
No
The device description and component list clearly indicate that the device consists of physical, stainless steel components used for dental impressions and casting, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The description and intended use clearly state that these components are restorative components used for taking impressions from dental fixtures and fabricating stone casts. They are used in the process of creating dental prosthetics for edentulous and partially edentulous patients.
- Lack of Biological Specimen Analysis: There is no mention of analyzing any biological specimens from the human body. The components are used in a mechanical process related to dental restoration.
- Anatomical Site: While the device is used in the mouth, it's not for analyzing tissues or fluids for diagnostic purposes.
- Predicate Devices: The predicate devices listed are also dental implant components, not IVDs.
Therefore, this device falls under the category of dental devices used for restorative purposes, not In Vitro Diagnostics.
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 |
|---|---|---|
| Replica 3.5 | 22398 | Prosthetic component which can be embedded into a stone cast model which replicates the interior shape and exterior chamber and diameter of a fixture |
| Replica 4.0 | 22399 | Prosthetic component which can be embedded into a stone cast model which replicates the interior shape and exterior chamber and diameter of a fixture |
| Replica ST 4.5 | 22509 | Prosthetic component which can be embedded into a stone cast model which replicates the interior shape and exterior chamber and diameter of a fixture |
| Fixture Transfer - Short | 22841 | Single unit reseating type impression coping for accurate transfer of fixture location and angulation |
| Fixture Transfer - Long | 22842 | Single unit reseating type impression coping for accurate transfer of fixture location and angulation |
| Fixture Transfer ST - Short | 22847 | Two piece pick-up type impression coping for accurate transfer of fixture location and angulation |
| Fixture Transfer ST - Long | 22848 | Two piece pick-up type impression coping for accurate transfer of fixture location and angulation |
| Fixture Transfer PU - Short | 22867 | Multi-piece pick-up type impression coping for accurate transfer of fixture location and angulation |
| Fixture Transfer PU - Long | 22868 | Multi-piece pick-up type impression coping for accurate transfer of fixture location and angulation |
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The additional components provided for by this 510(k) are restorative components which will allow impression taking from the fixture level and fabrication of a stone cast with the fixture replicated in the correct position necessary to meet various clinical situations in partially and totally edentulous patients. The components are made of stainless steel. 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): 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
Ka 74737
510(k) SUMMARY Astra Tech Implants Dental System MAR 2 4 1998 Additional Components
Submitters Information
Astra Tech, Inc. 430 Bedford Street, Suite 100 Lexington, MA 02173 781-861-7707 Contact: Mr. Niklas Lidskog
Date Prepared
December 16, 1997
Name of Device
Astra Tech Implants - Dental System
Additional Prosthetic and Laboratory Components - Fixture transfers and Fixture replicas
Classification Name
Endosseous Implant
Predicate Devices
Similar Devices Previously Approved Under K931767 - Astra Tech Implants - Dental System
Steri-Oss Dental Implants, Impression Coping, Open tray hex transfer, Implant Analog
Description of Device and Intended Use
The additional components provided for by this 510(k) are restorative components which will allow impression taking from the fixture level and fabrication of a stone cast with the fixture replicated in the correct position necessary to meet various clinical situations in partially and totally edentulous patients. The components are made of stainless steel. The indications and uses for these additional components are not different from similar components of the predicate device.
1
is
:
| Product | Diameter
(mm) | Part Number |
|---------------------|------------------|-------------|
| Replica | 3.5 | 22398 |
| Replica | 4.0 | 22399 |
| Replica ST | 4.5 | 22509 |
| Fixture Transfer | Short | 22841 |
| Fixture Transfer | Long | 22842 |
| Fixture Transfer ST | Short | 22847 |
| Fixture Transfer ST | Long | 22848 |
| Fixture Transfer PU | Short | 22867 |
| Fixture Transfer PU | Long | 22868 |
: 上
:
.
.
: : : : :
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 4 1998
Mr. Niklas Lidskog ·President Astra Tech, Incorporated 430 Bedford Street, Suite 100 Lexington, Massachusetts 02173
K974737 Re : Astra Tech Implant Dental System Trade Name: Regulatory Class: III Product Code: DZE Dated: December 16, 1997 Received: December 19, 1997
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. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set ... forth in the Quality System Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, the Food and Drug Administration (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 section 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations .
3
Page 2 - Mr. Lidskog
On August 16, 1993 the Final Rule for Device Tracking was published in the Federal Register, pages 43442-43455 (copy enclosed). Be advised that under Section 519(e) of the Act as amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires tracking. Because the device is subject to tracking, you are required to adopt a method of tracking that follows the devices through the distribution chain and then identifies and follows the patients who receive them. The specific requirements of the regulation are found in 21 CFR 821 as described in the August 16, 1993 Federal Reqister beginning on page 43447.
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 regulation (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/dsma/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
4
510(k) Number (if known): K974737 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 |
|-----------------------------|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Replica 3.5 | 22398 | Prosthetic component which can be embedded into a stone
cast model which replicates the interior shape and exterior
chamber and diameter of a fixture |
| Replica 4.0 | 22399 | Prosthetic component which can be embedded into a stone
cast model which replicates the interior shape and exterior
chamber and diameter of a fixture |
| Replica ST 4.5 | 22509 | Prosthetic component which can be embedded into a stone
cast model which replicates the interior shape and exterior
chamber and diameter of a fixture |
| Fixture Transfer - Short | 22841 | Single unit reseating type impression coping for accurate
transfer of fixture location and angulation |
| Fixture Transfer - Long | 22842 | Single unit reseating type impression coping for accurate
transfer of fixture location and angulation |
| Fixture Transfer ST - Short | 22847 | Two piece pick-up type impression coping for accurate
transfer of fixture location and angulation |
| Fixture Transfer ST - Long | 22848 | Two piece pick-up type impression coping for accurate
transfer of fixture location and angulation |
| Fixture Transfer PU - Short | 22867 | Multi-piece pick-up type impression coping for accurate
transfer of fixture location and angulation |
| Fixture Transfer PU - Long | 22868 | Multi-piece pick-up type impression coping for accurate
transfer of fixture location and angulation |
(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)
Division of Infection Control,
and General Hospital Devices
510(k) Numbo: | Ox 7 137