(64 days)
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No
The summary describes a physical implant system and abutment, with no mention of software, algorithms, or AI/ML terms.
No.
The device is used to support prosthetic restoration, which is a structural or cosmetic function, not a therapeutic one that treats a disease or condition.
No
The provided text describes implant systems and abutments used for prosthetic restoration, which are treatment devices, not diagnostic ones. There is no mention of identifying, detecting, or assessing a medical condition.
No
The device description clearly states it is a "conical abutment," which is a physical component used in dental implants, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as an implant system used to support or attach prosthetic restorations in the mouth (mandibles and maxillae). This is a surgical and restorative procedure performed directly on the patient's body.
- Device Description: The device is described as a conical abutment designed for use with an endosseous implant in the jaw. This is a physical component implanted into the bone.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided description does not mention any interaction with bodily specimens or diagnostic purposes.
Therefore, this device falls under the category of a medical device used for surgical and restorative purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Implant systems are for use in single tooth, partially edentulous, completely edentulous, mandibles and maxillae as a support or attachment for prosthetic restoration. The restoration can be detachable (screw relained) prosthetics in multiple, free standing or terminal restorations.
Product codes
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Device Description
The conical abutment is designed for use with an endosseous implant which is implanted in the lower or upper jaw. The conical abutment provides a base for the restorative crown or bridgework.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower or upper jaw
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)
K924589, K954512, K944964, K961728
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
Image /page/0/Picture/4 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the digits '9', '6', '5', '1', '3', and '5'. The digits are written in a clear and legible manner, with consistent spacing between them. The handwriting style appears to be casual and informal.
Image /page/0/Picture/5 description: The image shows the logo for LIFECORE BIOMEDICAL. The word "LIFECORE" is in large, bold, sans-serif font. Below the word "LIFECORE" are three small squares, and below the squares is the word "BIOMEDICAL" in a smaller, sans-serif font.
FEB 2 5 1997
510(k) Summary
- VII Summary of Safety and Effectiveness As required by 807.92(c).
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- This summary of Safety and Effectiveness is being submitted by: Lifecore Biomedical, Inc. 3515 Lyman Blvd Chaska, MN 55318 (612) 388 4300 Fax: (612) 368 3411
Contact Person: Donna Bahls Regulatory Affairs Manager, Oral Restorative Division
Date: December 13, 1996
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- Trade Name: Lifecore Conical Abutment Common Name: Conical Abutment Precision Attachment for use as an Classification Name: accessory for Class III Endosseous Implants (per 21 CFR 872.3165).
- The device is substantially equivalent to the commercially marketed 3. Equivalent Device: products known as Lifecore Conical Abutments Systems (K924589, K954512), Bråninark Miruscone Abutment System (K944964, K961728), 3i Microminiplant System (Catalog # MCA 31-MCA 34), and Sten-Oss HL Abutment System (Catalog # 2654-2657).
- Device Description: The conical abutment is designed for use with an endosseous implant 4. which is implanted in the lower or upper jaw. The conical abutment provides a base for the restorative crown or bridgework.
- Intended Use: Implant systems are for use in single tooth, partially edentulous, completely 5. edentulous, mandibles and maxillae as a support or attachment for prosthetic restoration. The restoration can be detachable (screw relained) prosthetics in multiple, free standing or terminal restorations.
- The technological characteristics of the modified version of the conical abutment and the 8. earlier versions are identical. The titanium used in both devices is the same. Manufacturing processes are also the same as is general shape and structure. Therefore, no new types of technology and no new technological questions are involved.
3515 LYMAN BOULEVARD • CHASKA, MINNESOTA • 55318 -3051 • USA 6 1 2 = 3 6 8 - 4 3 0 0 F A X : 6 1 2 = 3 6 8 - 3 4 1 1
Image /page/0/Picture/18 description: The image shows a recycling symbol with the letter 'P' to the right of it. The recycling symbol is a triangle formed by three arrows pointing in a clockwise direction. The letter 'P' is in uppercase and appears to be in a simple, sans-serif font. The image is black and white.