← Product Code [DZE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE) · K965135 # LIFECORE CONICAL ABUTMENT (K965135) _Lifecore Biomedical, Inc. · DZE · Feb 25, 1997 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE/K965135 ## Device Facts - **Applicant:** Lifecore Biomedical, Inc. - **Product Code:** [DZE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE.md) - **Decision Date:** Feb 25, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3640 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## 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 retained) prosthetics in multiple, free standing or terminal restorations. ## Device Story Conical abutment serves as interface between endosseous implant and prosthetic crown or bridgework; provides base for screw-retained detachable prosthetics. Used in oral surgery/restorative dentistry by clinicians. Device functions as mechanical support for dental restorations in upper or lower jaw. ## Clinical Evidence Bench testing only; no clinical data provided. ## Technological Characteristics Titanium construction; mechanical attachment for endosseous implants; conical form factor; non-powered; sterile. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - Lifecore Conical Abutments Systems ([K924589](/device/K924589.md), [K954512](/device/K954512.md)) - Bränimark Miruscone Abutment System ([K944964](/device/K944964.md), [K981728](/device/K981728.md)) - 3i Microminilplant System (Catalog # MCA 31-MCA 34) - Steri-Oss HL Abutment System (Catalog # 2654-2657) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FEN-24-31 HUN 00.02 LIFECURE BIOMEDICAL FAX NO. 6123683411 P.03 1<965135 # LIFECORE ## BIOMEDICAL FEB 25 1997 510(k) Summary VII Summary of Safety and Effectiveness As required by 807.92(c). 1. 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 2. Trade Name: Lifecore Conical Abutment Common Name: Conical Abutment Classification Name: Precision Attachment for use as an accessory for Class III Endosseous Implants (per 21 CFR 872.3165). 3. Equivalent Device: The device is substantially equivalent to the commercially marketed products known as Lifecore Conical Abutments Systems (K924589, K954512), Bränimark Miruscone Abutment System (K944964, K981728), 3i Microminilplant System (Catalog # MCA 31-MCA 34), and Steri-Oss HL Abutment System (Catalog # 2654-2657). 4. 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. 5. Intended 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 retained) prosthetics in multiple, free standing or terminal restorations. 6. The technological characteristics of the modified version of the conical abutment 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 • USA 612.368-4300 FAX: 612.368-3411 PRINTED ON RECYCLED PAPER WITH 19% POST-CONSUMER --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE/K965135](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE/K965135) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com