(190 days)
No
The summary describes standard dental implant components (implants, tools, abutments) and their intended use in facilitating the prosthetic phase. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
No.
The document states that the device is intended to "facilitate the prosthetic phase and installation of the prosthesis for the patient," which describes a prosthetic aid rather than a device used for treating disease or injury.
No
The device description indicates that the abutments facilitate the prosthetic phase and installation of a prosthesis, and are placed on implants. This describes a restorative or prosthetic function, not a diagnostic one.
No
The device description explicitly states that the system consists of "Endosseous implant implants, tools and abutments," which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as facilitating the prosthetic phase and installation of a prosthesis for the patient. This is a direct treatment or restoration of a physical condition, not a diagnostic test performed on samples from the body.
- Device Description: The device consists of implants, tools, and abutments, which are all components used in a surgical and prosthetic procedure within the patient's body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is clearly intended for use in vivo (within the living body) for dental restoration, not in vitro (in glass or outside the body) for diagnostic purposes.
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 the patient.
Product codes
Not Found
Device Description
system consists of Endosseous implant 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K902433, K902434, K902435, K932123, K925766, K934826, K934495, K933969, K934126, 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
Tissue Regeneration
Image /page/0/Picture/3 description: The image shows three palm trees in silhouette. The trees are evenly spaced and appear to be of similar size. The leaves of the palm trees are jagged and irregular, and the trunks are thin and straight.
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:
system consists of Endosseous implant 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. for the patient. 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