(24 days)
No
The device description and intended use focus on physical components (abutments and screws) for dental implants, with no mention of software, algorithms, or AI/ML capabilities.
No.
The device components are described as bases for custom abutment post construction and attachment elements for connecting abutments to fixtures in dental implant systems; they do not perform a therapeutic function.
No
This device is used in cement-retained crown and bridge construction, specifically as a base for customized abutment post construction and as attachment elements for fixtures. Its function is to build or attach, not to diagnose a condition.
No
The device description clearly outlines physical components made of gold alloy (Cast-to Abutments and Abutment Screws) used in dental procedures, indicating it is a hardware device, not software-only.
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 is for "cement retained crown and bridge construction" and describes components used in dental implant systems for connecting abutments to fixtures and creating customized abutment posts. This is a mechanical/structural function within the body, not a diagnostic test performed on samples outside the body.
- Device Description: The description details the materials (gold alloy) and function of the components (base for casting, attachment elements). This aligns with a medical device used for implantation and restoration, not a diagnostic test.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Reagents, calibrators, or controls
The device described is a dental implant component, which falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For use in cement retained crown and bridge construction.
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 |
|---|---|---|
| Cast-to Abutment 3.5 | 22827 | Used as a base for cast-to customized abutment post construction. Allowing for compensation of poorly aligned fixtures and for meeting esthetic demands for design and position of the crown margin. |
| Cast-to Abutment 4.0 | 22828 | Used as a base for cast-to customized abutment post construction. Allowing for compensation of poorly aligned fixtures and for meeting esthetic demands for design and position of the crown margin. |
| Cast-to Abutment ST | 22829 | Used as a base for cast-to customized abutment post construction. Allowing for compensation of poorly aligned fixtures and for meeting esthetic demands for design and position of the crown margin. |
| Abutment Screw, Ultra-gold (sterile) | 22838 | Attachment element for connection/fixation of abutments to fixtures |
| Abutment Screw, ST- gold (sterile) | 22839 | Attachment element for connection/fixation of abutments to fixtures |
Product codes
DZE
Device Description
Cast-to Abutment, Cast-to Abutment ST and Abutment Screws- Gold - are ADDITIONAL COMPONENTS to the Astra Tech Dental Implant System.
The Cast-to abutments are manufactured in gold alloy and are used as a base for castto customized abutment post construction. Allowing for compensation of poorly aligned fixtures and for meeting esthetic demands for design and position of the crown margin.
The Abutment Screws are manufactured in gold alloy and are attachment elements for connection/fixation of abutments to fixtures.
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)
K931767, STERI-OSS REPLACE Direct Abutment 5.0 Series
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
Ka806ax
MAR 1 9 1998
510(k) SUMMARY Astra Tech Implants Dental System Additional Components
Submitters Information
Astra Tech, Inc. 430 Bedford Street, Suite 100 Lexington, MA 02173 Contact: Mr. Niklas Lidskog
Date Prepared
February 20, 1998
Name of Device
Astra Tech Implants - Dental System Cast-to Abutment, Cast-to Abutment ST and Abutment Screws- Gold - are ADDITIONAL COMPONENTS for cement retained crown and bridge constructions
Classification Name
Endosseous Implant
Predicate Devices
Similar Devices Previously Approved Under K931767 - Astra Tech Implants - Dental System (Abutment Screw ST) STERI-OSS REPLACE Direct Abutment 5.0 Series
Description of Device and Intended Use
Cast-to Abutment, Cast-to Abutment ST and Abutment Screws- Gold - are ADDITIONAL COMPONENTS to the Astra Tech Dental Implant System.
The Cast-to abutments are manufactured in gold alloy and are used as a base for castto customized abutment post construction. Allowing for compensation of poorly aligned fixtures and for meeting esthetic demands for design and position of the crown margin.
The Abutment Screws are manufactured in gold alloy and are attachment elements for connection/fixation of abutments to fixtures.
1
List of Components
(
| Product | Diameter
(mm) | Part Number |
|----------------------------------------|------------------|-------------|
| Cast-to Abutment 3.5 | 4.5 | 22827 |
| Cast-to Abutment 4.0 | 4.5 | 22828 |
| Cast-to Abutment ST | 5.5 | 22829 |
| Abutment Screw Ultra-gold
(Sterile) | 2.6 | 22838 |
| Abutment Screw ST-gold
(Sterile) | 2.6 | 22839 |
:
.
・
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, abstract style.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 9 1998
Mr. Niklas Lidskog ·President Astra Tech, Incorporated 430 Bedford Street, Suite 100 Lexington, Massachusetts 02173
Re : K980698 Astra Tech Implants - Dental System Trade Name: Regulatory Class: III Product Code: DZE Dated: February 20, 1998 February 23, 1998 Received:
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. ਸੈ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as-set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. 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 Requlations.
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 Register 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 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.qov/cdrh/dsma/dsmamaim.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
18069 510(k) Number(if known): Device Name: ASTRA TECH IMPLANTS - DENTAL SYSTEM
Indications for Use:
For use in cement retained crown and bridge construction.
The following table describes the indication for use for each component listed as part of this 510(k) submission:
| Part | ||
|---|---|---|
| Component | Number | Indication for Use |
| Cast-to Abutment 3.5 | 22827 | Used as a base for cast-to customized abutment post construction. |
| Allowing for compensation of poorly aligned fixtures and for meeting | ||
| esthetic demands for design and position of the crown margin. | ||
| Cast-to Abutment 4.0 | 22828 | Used as a base for cast-to customized abutment post construction. |
| Allowing for compensation of poorly aligned fixtures and for meeting | ||
| esthetic demands for design and position of the crown margin. | ||
| Cast-to Abutment ST | 22829 | Used as a base for cast-to customized abutment post construction. |
| Allowing for compensation of poorly aligned fixtures and for meeting | ||
| esthetic demands for design and position of the crown margin. | ||
| Abutment Screw, Ultra- | ||
| gold (sterile) | 22838 | Attachment element for connection/fixation of abutments to fixtures |
| Abutment Screw, ST- gold | ||
| (sterile) | 22839 | Attachment element for connection/fixation of abutments to fixtures |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
0 M Prescription Line ... or (Per 21 CFR 801.1091) (Optional format 1-2-9G)
... Over-the-Counter-Use . . . .......
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Sumner
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
K>20698