Component	PartNumber	Indication for Use
Replica 3.5	22398	Prosthetic component which can be embedded into a stonecast model which replicates the interior shape and exteriorchamber and diameter of a fixture
Replica 4.0	22399	Prosthetic component which can be embedded into a stonecast model which replicates the interior shape and exteriorchamber and diameter of a fixture
Replica ST 4.5	22509	Prosthetic component which can be embedded into a stonecast model which replicates the interior shape and exteriorchamber and diameter of a fixture
Fixture Transfer - Short	22841	Single unit reseating type impression coping for accuratetransfer of fixture location and angulation
Fixture Transfer - Long	22842	Single unit reseating type impression coping for accuratetransfer of fixture location and angulation
Fixture Transfer ST - Short	22847	Two piece pick-up type impression coping for accuratetransfer of fixture location and angulation
Fixture Transfer ST - Long	22848	Two piece pick-up type impression coping for accuratetransfer of fixture location and angulation
Fixture Transfer PU - Short	22867	Multi-piece pick-up type impression coping for accuratetransfer of fixture location and angulation
Fixture Transfer PU - Long	22868	Multi-piece pick-up type impression coping for accuratetransfer of fixture location and angulation

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.

AI/ML Overview

This 510(k) submission pertains to additional prosthetic and laboratory components for the Astra Tech Implants - Dental System, specifically fixture transfers and fixture replicas. The submission states that "The indications and uses for these additional components are not different from similar components of the predicate device." This is a key point, as it indicates that the device is being cleared based on substantial equivalence to a predicate device, rather than requiring extensive clinical trials to prove new performance criteria.

Therefore, the "acceptance criteria" for this submission are primarily focused on demonstrating that the new components perform identically or equivalently to the predicate devices and existing components of the Astra Tech Implants - Dental System. The study supporting this claim would be a verification study, likely laboratory-based, demonstrating dimensional accuracy, fit, and function.

However, the provided document does not contain a detailed study report with specific acceptance criteria and device performance results in the way one would expect for a more complex medical device requiring clinical efficacy or safety trials. The 510(k) summary focuses on the description of the device and its intended use, along with the predicate devices. This is typical for submissions relying heavily on substantial equivalence for simpler component additions.

Based on the provided information, I can deduce the following:

1. Table of Acceptance Criteria and Reported Device Performance:

Since a detailed study report is not provided, the "acceptance criteria" are implied by the nature of the device (prosthetic components for dental implants) and the substantial equivalence claim. The reported device performance is implicitly assumed to be equivalent to the predicate device as the basis for 510(k) clearance.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Dimensional Accuracy: Replicas and transfers accurately match the dimensions and geometry for their intended fit with implant fixtures and creation of dental casts.	Components are designed to accurately replicate and transfer fixture location and angulation, implicitly meeting the dimensional requirements for proper fit and function in a dental prosthesis workflow.
Material Compatibility: Components are made of biocompatible materials suitable for their intended use (e.g., stainless steel).	Components are made of stainless steel, a commonly used and accepted material for such dental components.
Functional Equivalence: The new components allow for accurate impression taking and fabrication of stone casts, replicating the fixture in the correct position, identical to the predicate device.	The components are designed to meet various clinical situations in partially and totally edentulous patients, fulfilling the same functional purpose as similar components of the predicate device.
Sterilization Compatibility (if applicable for transfers): If designed for direct patient contact during impression taking, they would be sterilizable and maintain integrity (though this is typically a manufacturing control rather than a specific performance test for this type of component).	(Not explicitly stated but implied by general manufacturing practices for medical devices).

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not explicitly stated. For a device like this, the "test set" would likely involve a small number of manufactured components tested for dimensional accuracy, fit, and potentially mechanical integrity in a laboratory setting. It would not be a "test set" in the sense of clinical patient data.
Data Provenance: Not explicitly stated. Given the nature of a 510(k) for components, the tests would be performed by the manufacturer, Astra Tech Inc., likely in a laboratory setting at their facility (Lexington, MA). The data would be prospective to the clearance application.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

Number of Experts: Not explicitly stated. For a device relying on substantial equivalence and laboratory testing, "ground truth" would be established by engineering specifications, validated measurement techniques, and potentially conformity to ISO or ASTM standards. This would typically involve product designers, mechanical engineers, and quality control personnel.
Qualifications: Likely engineers and quality assurance specialists with expertise in dental implant mechanics and manufacturing tolerances.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable in the context of this 510(k) and the type of device. Adjudication methods like "2+1" or "3+1" are relevant for clinical studies where human readers are making subjective assessments that need to be reconciled. For mechanical components, performance is typically measured against objective engineering specifications.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where different readers interpret cases. These dental implant components do not involve human interpretation of medical images or data in a diagnostic context.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:

Standalone Performance: Not applicable. This device is a physical prosthetic component, not an algorithm or AI system.

7. The Type of Ground Truth Used:

Ground Truth: Engineering specifications and established manufacturing tolerances for dental implant components. The "ground truth" for demonstrating substantial equivalence is the validated performance and design of the predicate device. This would include dimensional accuracy, material properties, and functional compatibility within the dental implant system.

8. The Sample Size for the Training Set:

Sample Size for Training Set: Not applicable. This device is a physical product, not a machine learning algorithm that requires a "training set." The design and manufacturing processes are established through engineering principles, prior knowledge of dental implant systems, and experience with predicate devices.

9. How the Ground Truth for the Training Set was Established:

Ground Truth for Training Set: Not applicable, as there is no training set in the context of an algorithm. The design principles and manufacturing specifications were established through engineering design processes, adherence to relevant standards (e.g., ISO for medical devices, dental materials), and the proven performance history of the predicate device (Astra Tech Implants - Dental System, Steri-Oss Dental Implants). These would have been validated through mechanical testing, material analysis, and potentially in vitro simulations.

In summary, the 510(k) for these additional Astra Tech Dental Implant components is based on substantial equivalence to existing, legally marketed predicate devices. The "study" proving this would have been a set of internal engineering verification and validation tests demonstrating that the new components meet the same functional and dimensional requirements as the known predicate devices, thereby ensuring they perform as intended and are safe and effective for their indicated use. The document provided does not detail these specific tests, which is common for 510(k) summaries of such component additions.

Summary

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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

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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

: : : : :

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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 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 .

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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

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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	PartNumber	Indication for Use
Replica 3.5	22398	Prosthetic component which can be embedded into a stonecast model which replicates the interior shape and exteriorchamber and diameter of a fixture
Replica 4.0	22399	Prosthetic component which can be embedded into a stonecast model which replicates the interior shape and exteriorchamber and diameter of a fixture
Replica ST 4.5	22509	Prosthetic component which can be embedded into a stonecast model which replicates the interior shape and exteriorchamber and diameter of a fixture
Fixture Transfer - Short	22841	Single unit reseating type impression coping for accuratetransfer of fixture location and angulation
Fixture Transfer - Long	22842	Single unit reseating type impression coping for accuratetransfer of fixture location and angulation
Fixture Transfer ST - Short	22847	Two piece pick-up type impression coping for accuratetransfer of fixture location and angulation
Fixture Transfer ST - Long	22848	Two piece pick-up type impression coping for accuratetransfer of fixture location and angulation
Fixture Transfer PU - Short	22867	Multi-piece pick-up type impression coping for accuratetransfer of fixture location and angulation
Fixture Transfer PU - Long	22868	Multi-piece pick-up type impression coping for accuratetransfer 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
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(Division Sign-Off)

Division of Infection Control,

and General Hospital Devices

510(k) Numbo: | Ox 7 137

Regulation Number and Section

§ 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.