(190 days)
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No
The summary describes dental abutments and implants, with no mention of AI, ML, image processing, or any computational analysis of data.
No.
The device components are described as facilitating the prosthetic phase and installation of a prosthesis, which are supportive functions rather than directly therapeutic.
No
The device is described as an endosseous implant system consisting of implants, tools, and abutments used to facilitate the prosthetic phase and installation of a prosthesis. Its function is to support a dental prosthesis, not to diagnose a condition.
No
The device description explicitly states it consists of "implants, tools and abutments," which are physical hardware components. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate the prosthetic phase and installation of the prosthesis for the patient." This describes a device used in vivo (within the body) for a therapeutic or restorative purpose, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details implants, tools, and abutments that are placed on top of implant fixtures. This is consistent with a dental prosthetic system used directly on a patient.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), diagnostic testing, or providing information for diagnosis.
Therefore, this device falls under the category of a medical device used for treatment and restoration, not an in vitro diagnostic device.
N/A
Intended Use / 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 eacilitate the prosthetic phase and installation of the prosthesis for the patient.
Product codes
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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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K902433, K902434, K902435, K932123, K925766, K934826, K934495, K933969, K934126, K933462
Reference Device(s):
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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).
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§ 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
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"
1
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