(9 days)
The Ceramic Abutment is intended for customized prosthetic treatment. The Ceramic Abutment is used with dental implant supported restorations in the anterior, canine, and premolar regions where high esthetic demands are expressed.
This 510k describes an additional component for the Astra Tech Implants -Dental System, the Ceramic Abutment. Ceramic Abutment 4.5/5.0 ST ø 5.5 mm. The Ceramic Abutment is a transmucosal element that can be customized to meet high anatomical and esthetic demands. The Ceramic Abutment is designed to allow for individual solutions regarding function and esthetics. It is intended for cement-retained constructions and follows the same preparation principles as for reqular crown and bridgework. The cement-retained superstructure excludes the need for non-esthetic screw entries through the crown. The design provides flexibility to mimic the anatomy of a natural tooth and to compensate for non-parallel fixtures. The esthetic properties of the Ceramic Abutment create a natural appearance of the soft tissue marqin as well as a better result for the all-ceramic crown restoration. The Ceramic Abutment is ground and customized to its ideal shape using diamond wheels/burrs or silicone carbide stones. The Ceramic Abutment has a conical relation to the fixture which enables a tight and stable connection between the components. There is a hexagonal interlock in relation to the fixture for antirotation and indexing. The Ceramic Abutment is connected to the fixture and tightened with the Abutment Screw ST/Long using a Hex screwdriver or Hex CA Driver.
The provided document is a 510(k) summary for the Astra Tech Ceramic Abutment and an FDA clearance letter. It describes the device, its intended use, and the basis for substantial equivalence to predicate devices, including performance testing. However, it does not explicitly define specific acceptance criteria (numerical thresholds for performance metrics) or detail a study design that directly proves the device meets such criteria.
The document states: "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." but does not provide the specifics of these tests, their results, or the acceptance thresholds used.
Therefore, many of the requested details cannot be extracted from the given text. Below is an attempt to answer the questions based on the available information, noting where information is missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric (If available) | Acceptance Threshold (If available) | Reported Device Performance (If available) |
|---|---|---|---|
| Functionality | (Not specified beyond "functionality") | (Not specified) | "Device functionality and conformance to design input requirements" confirmed through laboratory testing. Details not provided. |
| Material Properties | (Implied by comparison to predicate) | (Implied by comparison to predicate) | "Very similar in terms of size, materials of construction, performance characteristics, and basic design" to predicate devices. |
| Mechanical Performance | (Implied by comparison to predicate) | (Implied by comparison to predicate) | "Performance testing" conducted. "Differences have no effects on the performance or safety of the Ceramic Abutments." |
| Safety | (Implied by comparison to predicate) | (Implied by comparison to predicate) | "Same types of safety and effectiveness characteristics are raised with each of the devices" (compared to predicates). |
Missing Information: Specific quantitative acceptance criteria or numerical results from performance testing are not provided in this 510(k) summary. The document focuses on declaring substantial equivalence based on similarity and confirmation of functionality, rather than detailed performance metrics against predefined thresholds.
2. Sample size used for the test set and the data provenance
Not applicable/Not provided. This document describes laboratory performance testing, not a clinical study involving a "test set" of patient data. The testing mentioned in the summary is "Laboratory testing."
- Sample Size for Test Set: Not specified.
- Data Provenance: Laboratory testing (not patient data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. This refers to laboratory performance testing and comparison to predicate devices, not studies requiring expert-established ground truth on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided. This refers to laboratory performance testing and comparison to predicate devices, not studies requiring adjudication of disagreements among experts on patient data.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This device is a dental implant component. The provided document details its physical characteristics, intended use, and substantial equivalence, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This device is a dental implant component. Not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided in the context of patient data. The "ground truth" for this device's performance testing would be engineering specifications, material standards, and benchmark performance of the predicate devices. The document implies that the device confirmed "conformance to design input requirements."
8. The sample size for the training set
Not applicable/Not provided. This refers to laboratory performance testing and comparison to predicate devices, not machine learning model training.
9. How the ground truth for the training set was established
Not applicable/Not provided. This refers to laboratory performance testing and comparison to predicate devices, not machine learning model training. The "ground truth" for the physical and material properties would have been established through engineering design, material specifications, and regulatory standards.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the text "NOV 7 2002". The text appears to be a date, with the month being November, the day being the 7th, and the year being 2002. The text is in a simple, sans-serif font. The image is a close-up of the text, and the background is not visible.
510K Summary of Safety and Effectiveness
Astra Tech Ceramic Abutment October 28, 2002
-
- Sponsor Name Astra Tech, INC. 430 Bedford St, Suite 100 Lexington, MA 02240
-
- Device Name
Proprietary Name: Astra Tech Implants - Dental System 'Ceramic Abutment' Common Name: Dental Implant Classification name: Endosseous Dental Implant (21 CFR 872.3640)
-
- Identification of Legally Marketed Device
- Astra Tech Implants Dental System 'Prepable Abutment System' o
- Nobel BioCare Ceradapt o
3i ZiReal Post
K number unknown K991947
-
- Device Description
0
- Device Description
This 510k describes an additional component for the Astra Tech Implants -Dental System, the Ceramic Abutment. Ceramic Abutment 4.5/5.0 ST ø 5.5 mm
The Ceramic Abutment is a transmucosal element that can be customized to meet high anatomical and esthetic demands. The Ceramic Abutment is designed to allow for individual solutions regarding function and esthetics. It is intended for cement-retained constructions and follows the same preparation principles as for reqular crown and bridgework. The cement-retained superstructure excludes the need for non-esthetic screw entries through the crown. The design provides flexibility to mimic the anatomy of a natural tooth and to compensate for non-parallel fixtures. The esthetic properties of the Ceramic Abutment create a natural appearance of the soft tissue marqin as well as a better result for the all-ceramic crown restoration. The Ceramic Abutment is ground and customized to its ideal shape using diamond wheels/burrs or silicone carbide stones. The Ceramic Abutment has a conical relation to the fixture which enables a tight and stable connection between the components. There is a
{1}------------------------------------------------
hexagonal interlock in relation to the fixture for antirotation and indexing. The Ceramic Abutment is connected to the fixture and tightened with the Abutment Screw ST/Long using a Hex screwdriver or Hex CA Driver.
- ട. Intended Use
The Ceramic Abutment is used with dental implant supported restorations in the anterior, canine, and premolar regions where high esthetic demands are expressed.
6 Comparison of Technological Characteristics
Substantial equivalence of the Ceramic Abutment is based on:
-
- Design similarities between the proposed Ceramic Abutments and the currently marketed Prepable Abutment System
-
- Performance testing. The proposed and currently marketed devices are very similar in terms of size, materials of construction, performance characteristics, and basic design.
The differences have no effects on the performance or safety of the Ceramic Abutments as evaluated in the performance testing. The same types of safety and effectiveness characteristics are raised with each of the devices.
In summary, the Ceramic Abutment described in this submission is, in our opinion, substantially equivalent to the predicate devices listed, which provide the same or similar functions, as well as design and technological characteristics. The intended use, statement of indications, technological characteristics and testing for the Ceramic Abutments support the concept of substantial equivalence.
-
- Performance Testing
Laboratory testing was conducted to determine device functionality and conformance to design input requirements.
- Performance Testing
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 2002 NOV
Astra Tech, Incorporated C/O Mr. Bruce Manning New England Biomedical Research, Incorporated 96 West Main Street P.O. Box 809 Northborough, Massachusetts 01532
Re: K023631
Trade/Device Name: Astra Tech Implants - Dental System Ceramic Abutment' Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: NHA Dated: October 28, 2002 Received: October 29, 2002
Dear Mr. Manning:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{3}------------------------------------------------
Page 2 - Mr. Manning
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); 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.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
{4}------------------------------------------------
| 510(k) Number (if known): | KO23631 |
|---|---|
| --------------------------- | --------- |
Astra Tech Implants - Dental System 'Ceramic Abutment' Device Name:
Indications For Use:
The Ceramic Abutment is intended for customized prosthetic treatment.
The Ceramic Abutment is used with dental implant supported restorations in the anterior, canine, and premolar regions where high esthetic demands are expressed
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use レデ
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
Sivar Runner
Division of Anesthesiology, General Hospital. Infection Control, Dental Devices
510(k) Number __
§ 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.)