(17 days)
The BASIC Dental Implant System Post & Core - Thin Attachment is indicated for attaching artificial teeth to a dental implant.
The Post and Core - Thin Attachment is a one-piece attachment. The base is cemented into a dental implant. Artificial teeth are then attached to the Post and Core - Thin using conventional techniques.
The provided document is a 510(k) summary for the BASIC Dental Implant System Post and Core - Thin Attachment, submitted to the FDA in 2002. This summary states that no performance data or results of clinical studies were provided for this device. Instead, the submission concluded that the device is "substantially equivalent to other existing Post and Core attachments in commercial distribution."
Therefore, based solely on the provided information, it is not possible to describe acceptance criteria or a study proving the device meets those criteria, as none were included in this 510(k) summary.
In such a scenario for a 510(k) submission, the FDA's determination of substantial equivalence often relies on:
- Comparison to a Legally Marketed Predicate Device: The current device (Post and Core - Thin Attachment) is compared to a predicate device (BASIC Dental Implant System Post and Core Attachment, K960868). The assumption is that if the new device has the same intended use, similar technological characteristics, and raises no new questions of safety and effectiveness, then the performance data of the predicate device (or lack thereof, if also cleared through substantial equivalence without new performance data) is deemed sufficient.
- Existing Standards: While not explicitly mentioned here, for certain device types, compliance with recognized industry standards might be cited in lieu of novel performance studies.
To answer your specific questions based on the provided text, the response would be as follows:
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A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not specified in the document. The basis for clearance was substantial equivalence to a predicate device, not meeting predefined performance criteria from a new study.
- Reported Device Performance: No performance data was reported or provided in this 510(k) summary.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable as no performance studies were conducted or provided for this submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as no performance studies were conducted or provided for this submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no performance studies were conducted or provided for this submission.
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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
- Not applicable. This device is a mechanical dental implant accessory, not an AI-assisted diagnostic tool. No MRMC study was performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a mechanical dental implant accessory, not an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable as no performance studies were conducted or provided for this submission.
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The sample size for the training set
- Not applicable as no computational or AI-based device was involved. No training set was used.
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How the ground truth for the training set was established
- Not applicable as no computational or AI-based device was involved. No training set was used.
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SEP 2 0 2002
510(K) Summary BASIC Dental Implant System Post and Core - Thin Attachment
Attachment I
This 510(K) Summary of safety and effectiveness for the BASIC Dental Implant System Post and Core -This 910(x) Daminal you sales) accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.
| Applicant: | BASIC Dental Implant Systems, Inc. |
|---|---|
| Address: | 3321 Columbia NEAlbuquerque, New Mexico 87107USA |
| Contact Person: | Dan Blacklock, Vice-President |
| Telephone / Fax / Email | 505.881.1376 - Phone505.884.1923 - Fax |
| Preparation Date: | August 28, 2002 |
| Device Trade Name: | BASIC Dental Implant System Post and Core - ThinAttachment |
| Common Name: | Accessory to a Dental Implant |
| Classification: | DZE |
| Legally Marketed Predicate Device: | BASIC Dental Implant System Post and Core AttachmentK number K960868 |
| Description of the Post and Core - ThinAttachment: | The Post and Core - Thin Attachment is a one-pieceattachment. The base is cemented into a dental implant.Artificial teeth are then attached to the Post and Core - Thinusing conventional techniques. |
| Intended use: | The Post and Core - Thin Attachment is intended to attachartificial teeth to a dental implant. |
| Performance Data: | None |
| Results of Clinical Study: | None |
| Conclusion: | The Post and Core-Thin attachment is substantiallyequivalent to other existing Post and Core attachments incommercial distribution |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 0 2002
Mr. Dan Blacklock Vice President BASIC Dental Implant Systems, Incorporated 3321 Columbia NE Albuquerque, New Mexico 87107
Re: K022912
Trade/Device Name: BASIC Dental Implant System Post & Core-Thin Attachment Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: August 28, 2002 Received: September 3, 2002
Dear Mr. Blacklock:
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.
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.
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Page 2 – Mr. Blacklock
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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Patrux Coccubffor
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATION FOR USE STATEMENT
| 510(k) Number: | Pending K022912 |
|---|---|
| ---------------- | ----------------- |
Device Name: BASIC Dental Implant System Post & Core - Thin Attachment
Indications for Use:
The BASIC Dental Implant System Post & Core - Thin Attachment is indicated for attaching artificial teeth to a dental implant.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (per 21 CFR 801.109) OR
Over-the-Counter Use
Susan Runge
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K032118
§ 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.