← Product Code [DZE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE) · K962845 # REPLACE HA COATED IMPLANTS (K962845) _Steri-Oss, Inc. · DZE · Oct 18, 1996 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE/K962845 ## Device Facts - **Applicant:** Steri-Oss, Inc. - **Product Code:** [DZE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE.md) - **Decision Date:** Oct 18, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3640 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Indications for Use The implant is indicated for use in restoring masticatory function in the edentulous and/or partially edentulous patient. ## Device Story Endosseous dental implant; serves as artificial root for prosthetic crown; restores masticatory function. Implant placed in jawbone; supports prosthetic devices. Used in dental clinics by clinicians. Benefits patient by replacing missing teeth and restoring chewing ability. ## Clinical Evidence No clinical data; substantial equivalence supported by mathematical justification. ## Technological Characteristics Endosseous implant; titanium and hydroxylapatite (HA) construction; threaded, tapered geometry; hexed superior surface. Diameters: 3.8, 5.0, 6.0 mm; lengths: 8-18 mm. 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 - Nobelpharma 3.75 mm implant ## 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} STERI-OSS A BAUSCH & LOMB Company Original 510(k) Replace HA Coated Implants 11962845 33 OCT 18 1996 # Section 6 ## 510(k) Summary ### Manufacturer Information: Submitter’s Name: Steri-Oss Inc. Address: 22895 Eastpark Drive Yorba Linda, CA 92887 U.S.A. Contact’s Name: Paul Gasser Regulatory Affairs Specialist Phone: 714-282-4800 Date Prepared: July 1996 ### Device Names: - Common Name: Implant - Trade Name: Replace HA Coated Implants - Classification Name: Endosseous implant ### Predicate Device: Substantial equivalence is claimed to Nobelpharma’s 3.75 mm implant. ### Device Description: How device functions: The Steri-Oss implant is designed to serve as support for prosthetic devices to restore patient chewing function. Page 1 of 2 Steri-Oss Inc. - July 1996 Steri-Oss Inc. 22895 Eastpark Drive Yorba Linda, CA 92887 • (714) 282-6515 Fax: (714) 998-9236 • (800) 993-8100 {1} Original 510(k) Replace HA Coated Implants ## Device Description (cont.): Scientific concepts: Natural dentition is composed of a root (subgingival) and a crown (supragingival). Designs in existence are intended to mimic this structure to aid the patient in restoring natural masticatory function. The implant is designed to serve as the root of the artificial tooth and the abutment/prosthetic is designed to serve as the crown. Characteristics: The implants are 3.8, 5.0 or 6.0 mm in diameter, from 8 - 18 mm in length and are composed of titanium and hydroxylapatite (HA). They are tapered, have a hexed superior surface, and are threaded. ## Intended Use: The implant is indicated for use in restoring masticatory function in the edentulous and/or partially edentulous patient. ## Comparison to Predicate: The following table provides a comparison of the technological characteristic of the Steri-Oss implant to the predicate. | Item | Predicate | Steri-Oss | | --- | --- | --- | | Material | Titanium | Titanium and HA | | Diameter (mm) | 3.75 | 3.8, 5.0, 6.0 | | Length (mm) | 7 - 20 | 8 - 18 | | Geometry | Threaded | Same | | Sterility | Sterile | Same | ## Performance Data: A mathematical justification demonstrates the substantial equivalence of the predicate to the Steri-Oss products. Steri-Oss Inc. - July 1996 --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE/K962845](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE/K962845) **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