(84 days)
Not Found
No
The summary describes a dental implant system and abutments, with no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No.
The device is a dental implant system used for restoration and support of dental prosthetics, not for treating or curing a disease or condition.
No
The device, Lifecore Sustain and Restore Dental Implant Systems, is described as intended for supporting dental restorations and overdenture retention. Its function is to provide physical support for prosthetics, not to diagnose medical conditions or diseases.
No
The device description clearly states it is an "abutment," which is a physical component used with dental implants. This indicates it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the device is a dental implant system and an abutment designed for use with an endosseous implant implanted in the jaw. This is a surgical device used in vivo (within the body).
- Intended Use: The intended uses all relate to supporting dental prosthetics within the mouth, which is an in vivo application.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting biomarkers, or any other activity typically associated with IVD devices.
Therefore, the Lifecore Sustain and Restore Dental Implant Systems are medical devices, but they are not IVDs.
N/A
Intended Use / Indications for Use
The Lifecore Sustain and Restore Dental Implant Systems are intended for use in either partially or fully edentulous mandibles or maxillae in the following areas:
- Support of fixed (cemented) restorations utilizing multiple abutments; .
- Support of fixed detachable (screw retained) prosthetics utilizing multiple abutments; ●
- Overdenture retention by means of a ball overdenture attachment, o-ring attachment, dalla bona or hader bar;
- Terminal or interniedlate abutment support for fixed bridgework; .
- Free standing restorations without involvement of adjacent dentition.
Product codes
DZE
Device Description
The abutment is designed for use with an endosseous implant which is implanted in the lower or upper jaw. The abutment is used as an attachment solution to overdentures. The technological characteristics of the modified versions of the o-ring and dalla bona abutments and the 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
edentulous mandibles or maxillae
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
MAY 27 99
្រី
ជាមួយ
510(k) Summarv
- VII Summary of Safety and Effectiveness As required by 807.92(c).
- This summary of Safety and Effectiveness is being submitted by: Lifecore Biomedical, Inc. 3515 Lyman Blvd Chaska, MN 55318 (612) 368 4300 Fax: (612) 368 3411
Contact Person: Donna Bahls Regulatory Affairs Manager, Oral Restorative Division
Date: December 13, 1996
-
- Trade Name: Lifecore O-Ring Abutment and Lifecore Dalla Bona Abutment Common Name: Overdenture Abutment Classification Name: Attachment accessory for Class III Endosseous Implants (per 21 CFR 872.3165).
- Device Description: The abutment is designed for use with an endosseous implant which is 4. implanted in the lower or upper jaw. The abutment is used as an attachment solution to overdentures.
- ഗ് Intended Use: Implant systems are for use in edentulous mandibles and maxillae as a support or attachment for prosthetic restoration ..
- છે. The technological characteristics of the modified versions of the o-ring and dalla bona abutments and the 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 U S A 8 612 2 3 6 8 -4300 FAX: 612 = 368 - 3 411
Image /page/0/Picture/13 description: The image contains a small, circular recycling symbol. The symbol is composed of three arrows that form a triangle, indicating the cyclical nature of recycling. The arrows are arranged in a clockwise direction, suggesting the continuous process of collecting, processing, and reusing materials. The image is simple and clear, effectively conveying the message of environmental responsibility and sustainability.
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 27 1997
Ms. Donna Bahls Requlatory Affairs Manager Oral Restorative Division … Lifecore Biomedical, Incorporated 3515 Lyman Boulevard Chaska, Minnesota 55318-3051 USA
Re : K970776 Lifecore O-Ring Abutment; Lifecore Dalla Trade Name: Bona Abutment Requlatory Class: III Product Code: DZE Dated: February 27, 1997 Received: March 4, 1997
Dear Ms. Bahls:
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, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, fitle 21, Parts 800 to 895. ನ್ನ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, 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 sections 531 through 542 of
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Page 2 - Ms. Bahls
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 qeneral 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/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use:
The Lifecore Sustain and Restore Dental Implant Systems are intended for use in either partially or fully edentulous mandibles or maxillae in the following areas:
- Support of fixed (cemented) restorations utilizing multiple abutments; .
- Support of fixed detachable (screw retained) prosthetics utilizing multiple abutments; ●
- Overdenture retention by means of a ball overdenture attachment, o-ring attachment, dalla bona or hader bar;
- Terminal or interniedlate abutment support for fixed bridgework; .
- Free standing restorations without involvement of adjacent dentition.
Susan Runner
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devi Ky K 510(k) Number