(190 days)
No
The summary describes standard dental implant components (implants, tools, abutments) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device, an endosseous implant system including abutments, facilitates the prosthetic phase of dental implants. It does not treat or cure a disease or condition, but rather aids in the restoration of dental function.
No
The device is described as an endosseous implant system, which includes implants, tools, and abutments used to facilitate the prosthetic phase and installation of a prosthesis for a patient. Its purpose is to support a prosthesis, not to diagnose a condition.
No
The device description explicitly states that the system consists of implants, tools, and abutments, which are physical hardware components used in dental procedures.
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 directly on or in the patient for a therapeutic or restorative purpose, not for testing samples from 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 medical device used in a surgical or dental procedure.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
Therefore, this device falls under the category of a medical device used for treatment or 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 facilitate the prosthetic phase and installation of the prosthesis for for the patient.
Product codes
Not Found
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Dental Imaging Associates - Pre-market notification #K902433, Dental Imaging Associates - K902434, Dental Imaging Associates - K902435, Implant Innovations - Pre-angled abutments - K932123, Nobelpharma - K925766, Nobelpharma - K934826, Nobelpharma - K934495, Implant Innovations - K933969, Implant Innovations - K934126, Implant Innovations - K933462
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 Beach
Surgical and Non-Surgical Pe Tissue Regeneration
Image /page/0/Picture/2 description: The image shows a sequence of handwritten characters. The characters are 'K961383'. The characters are written in black ink on a white background. The handwriting is somewhat stylized, with the 'K' having a distinct shape and the '3' having a curved form.
Image /page/0/Picture/3 description: The image shows three palm trees silhouetted against a white background. The trees are evenly spaced and appear to be of similar size. The trunks are slender and slightly curved, while the fronds are dense and rounded.
Jack T. Krauser, D.M.D. Periodontist & Director
Thomas A. Copulos, D.D.S. Periodontist
Re : 510 (k) Summary
SEP 25 1980
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 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 for the patient. Interstate Plaza Suite 302 1499 W. Palmetto Park Road N. Palm Beach, Florida 33408 Boca Raton 33486-3311 (407) 627-5560 (407) 392-4747 FAX (407) 627-4214 "Tomorrow's Technology Today" 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