← Product Code [DZE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE) · K960112 # KIS MT5 (K960112) _The Implant Center of the Palm Beaches · DZE · Mar 15, 1996 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE/K960112 ## Device Facts - **Applicant:** The Implant Center of the Palm Beaches - **Product Code:** [DZE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE.md) - **Decision Date:** Mar 15, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3640 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Indications for Use The wide body abutments and pre-angled abutments are similar to those of other implant systems in their intended use which is to facilitate the prosthetic phase and installation of the prosthesis for the patient. ## Device Story Endosseous implant system comprising implants, tools, and prosthetic abutments. Includes pre-machined angulated abutments (15 and 25 degrees) and wide-body abutments (4, 5, and 6 mm platforms). Used by periodontists/dentists in clinical settings to support prosthetic attachments following implant integration. Abutments placed on implant fixtures to enable fabrication and installation of dental prostheses. Benefits patient by allowing correction of angulation and providing stable support for prosthetic restorations. ## Clinical Evidence No clinical data provided; substantial equivalence based on design, material, and manufacturing similarity to predicate devices. ## Technological Characteristics Materials: ASTM B-348-93 titanium grade 3, 4, and titanium alloy ELI-grade 5. Components: Endosseous implants, tools, and prosthetic abutments (15/25-degree angulated; 4/5/6mm wide-body). Sterilization: Gamma radiation. Manufacturing: GMP compliant. ## 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 - Dental Imaging Associates ([K902433](/device/K902433.md)) - Dental Imaging Associates ([K902434](/device/K902434.md)) - Dental Imaging Associates ([K902435](/device/K902435.md)) - Implant Innovations - Pre-angled abutments ([K932123](/device/K932123.md)) - Nobelpharma ([K925766](/device/K925766.md)) - Nobelpharma ([K934826](/device/K934826.md)) - Nobelpharma ([K934495](/device/K934495.md)) - Implant Innovations ([K933969](/device/K933969.md)) - Implant Innovations ([K934126](/device/K934126.md)) - Implant Innovations ([K933462](/device/K933462.md)) ## 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} The Implant Center Of The Palm Beaches Surgical and Non-Surgical Periodontics, Oral Implantology. Tissue Regeneration K960112 Jack T. Krauser, D.M.D. Periodontist & Director Thomas A. Copulos, D.D.S. Periodontist Re: 510(k) Summary To Whom It May Concern: Pursuant to your request, information regarding the above-referenced PMN-510(k) summary for substantial equivalence of the above-referenced document is enclosed. The above-referenced devices have been reviewed by the CDRH, as well as the Office of Compliance and have received a substantial equivalence letter. ## Predicate Devices Dental Imaging Associates - Pre-market notification #K902433 Dental Imaging Associates - K902434 Dental Imaging Associates - K902435 Implant Innovations - Pre-angled abutments - K932123 ## Predicate Devices For Wide Body Nobelpharma - K925766 Nobelpharma - K934826 Nobelpharma - K934495 Implant Innovations - K933969 Implant Innovations - K934126 Implant Innovations - K933462 ## Device Description: Endosseous implant system consists of implants, tools and abutments. This submission includes pre-machined angulated abutments less than 30 degrees, specifically 15 and 25-degree abutments are included. In addition, in the wide-body abutment series, a series of one and two-piece prosthetic abutments are included in 4, 5 and 6 mm. platform diameters. These devices are similar in their use in that they are placed on top of the implant fixtures after the appropriate integration phase and prosthetic attachments are fabricated to these abutments. ## INTENDED USE: The wide body abutments and pre-angled abutments are similar to those of other implant systems in their intended use which is to facilitate the prosthetic phase and installation of the prosthesis for the patient. 824 U.S. Highway 1, Suite 370 N. Palm Beach, Florida 33408 (407) 627-5560 FAX (407) 627-4214 "Tomorrow's Technology Today" Interstate Plaza Suite 302 1499 W. Palmetto Park Road Boca Raton 33486-3311 (407) 392-4747 FAX (407) 392-8320 {1} # TECHNOLOGY CHARACTERISTIC SUMMARY: Design, material, manufacturing process, gamma sterilization, geometry and service and materials are similar to predicate devices currently on the market. This PMN includes devices to correct angulation changes as well as wide body implants for the prosthetic phase of the case. The materials are ASTM standard B-348-93 titanium grade 3, 4 and titanium alloy ELI-grade 5. GMP guidelines are in place to track the product development and manufacturing processes. Food & Drug Administration, Office of Compliance has inspected and deemed all stages of the GMP process are in compliance with GMP standards. If I can be of further assistance, please do not hesitate to contact me. Sincerely, Jack T. Krauser, D.M.D. JTK/ms 0035 --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE/K960112](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE/K960112) **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