(190 days)
The wide body abutments and pre-angled abutments are similar to those of other implant systems in their intended use which is to eacilitate the prosthetic phase and installation of the prosthesis for the patient.
Endosseous implant system consists of implants, tools and This submission includes pre-machined angulated abutments. 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.
The provided text describes a 510(k) summary for an endosseous implant system, focusing on its substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study demonstrating the device meets such criteria. The document is primarily a letter to the FDA seeking approval, outlining the device's description, intended use, and technological characteristics by comparing them to existing cleared devices.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving the device meets them based only on the provided text. The document is a regulatory submission, not a study report.
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The Implant Center Of The Palm Beac
Surators on Non-Sumical Park Tissue Regeneration
Image /page/0/Picture/2 description: The image shows a handwritten string of characters. The characters are K, 9, 6, 1, 3, 8, and 5. There is a horizontal line above the 5. The characters are written in black ink on a white background.
Image /page/0/Picture/3 description: The image shows a silhouette of three palm trees. The trees are arranged in a row, with each tree having a distinct crown of leaves. The trunks of the trees are slender and slightly curved, adding a touch of natural asymmetry to the composition.
Jack T. Krauser, D.M.D. Periodontist & Director
Thomas A. Copulos, D.D.S. Periodontist
Re : 510 (k) Summary
SEP 2 5 1996
To Whom It May Concern:
Pursuant to your request, information regarding the abovereferenced 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 This submission includes pre-machined angulated abutments. 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 eacilitate the prosthetic phase and installation of the prosthesis
for the patient. for the patient.
824 U.S. Highway 1, Suite 370 1499 W. Palmetto Park Road N. Palm Beach, Florida 33408 Boca Raton 33486-3311 (407) 627-5560 (407) 392-4747 FAX (407) 627-4214 FAX (407) 392-8320 "Tomorrow's Technology Today"
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TECHNOLOGY CHARACTERISTIC SUMMARY:
Design, material, manufacturing process, gamma sterilization, beometry 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
§ 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.