(69 days)
Not Found
No
The summary describes standard dental implant components (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 with abutments, facilitates prosthetic phases and installation of programs, but does not directly treat or cure a disease or condition.
No
The device description clearly states its purpose is to "facilitate the prosthetic phase" and includes "endosseous implant system tools" and "abutments," which are components for dental prosthetics, not for diagnosing conditions.
No
The device description explicitly states it consists of "Endosseous implant system tools and consists of implants, This submission includes pre-machined angulated abutments. abutments less than 30 degrees... In addition, in the wide-body abutment series, a series of one and two-piece prosthetic abutments are included". These are physical hardware components, not software.
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 programs and institute Moza Suite 302 for the patient." This describes a surgical and prosthetic procedure performed directly on a patient, not a test performed on a sample taken from the body.
- Device Description: The device description details "Endosseous implant system tools and consists of implants, This submission includes pre-machined angulated abutments... prosthetic abutments." These are physical components implanted into or attached to a patient's bone and used for dental restoration.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
The device described is a dental implant system and its associated components, which are considered medical devices used in a surgical and prosthetic context, not for in vitro diagnostic testing.
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 programs and institute Moza Suite 302 for the patient.
Product codes
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Device Description
Endosseous implant system 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
Not Found
Input Imaging Modality
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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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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
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
418 213 38 25 25 11.
Surgical and Non-Surgical Periodontics, Oral Implantology,
Tissue Regeneration
ack T. Krauser, D.M.D. Periodontist & Director
Thomas A. Copulos. D.D.S. Perlodontist
510 (k) Summary Re:
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:
tools and consists of implants, Endosseous implant system 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 facilitate the prosthetic phase and installation of the programs and institute Moza Suite 302 for the patient. 1499 W. Palmetto Park Road 824 U.S. Highway 1, Sulte 370 Boca Raton 33486-3311 N. Palm Beach, Florida 33408 (407) 392-4747 (407) 627-5560 FAX (407) 392-8320 "Tomorrow's Technology Today" FAX (407) 627-4214
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. Frood & 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