(190 days)
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No
The summary describes standard dental prosthetic components and tools, with no mention of AI or ML capabilities.
No
The devices described (abutments, impression posts, implant analogs, tools, and accessories) are used for the creation and retention of dental prostheses and do not directly treat or prevent a disease, injury, or condition.
No
The device description and intended use outline components used for dental prostheses (e.g., abutments, impression posts, analogs, tools) which are restorative or procedural in nature, not for diagnosing a condition or disease.
No
The device description explicitly lists physical components such as abutments, impression posts, implant analogs, tools, and accessories, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes devices used for dental prosthetics, including patterns for casting, registering implant locations, creating models, and temporary and permanent abutments. These are all mechanical or structural components used in the process of creating and placing dental restorations.
- Device Description: The device description lists components like abutments, posts, analogs, tools, and accessories, which are physical items used in dental procedures.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease, condition, or state of health. It does not analyze biological samples (like blood, urine, or tissue) or provide information for diagnostic purposes.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The devices described here are used in vivo (within the body) or as part of the process of creating devices for use in vivo.
N/A
Intended Use / Indications for Use
- Universal and UCLA Abutments are used as patterns for casting of prostheses. The prosthesis (restoration) will be fastened directly to implant by using a screw.
- Impression Posts are used to register the location and position of the implants in mouth.
- Implant Analogs are replicas of the implants and are mounted in stone model.
- Cement Retained Abutments are used when the abutment is being used as substructure and the crown is attached on it by using dental cement.
- Temporary Abutments are used while the prostheses are being made. This abutment will be used for a short time. A resin material such as Acrylic will be attached to it directly or by cement.
- Tools and Accessories, such as screwdrivers are used to screw in or tighten the screws, coping screw and housing are used to screw retain the coping on the prosthesis. Drill and reamer are used to smooth out the inner surfaces of abutments after casting.
All Universal, UCLA, Cement Retained and Temporary Abutments, Implant Analogs and Impression Posts are compatible and will be used with Branemark Regular Platform (RP) implants from Nobel Biocare, which have 2.70mm external hexagon and 2mm thread. All abutments will be used for fully or partially edentulous and/or for single tooth dental prostheses.
Product codes
DZE
Device Description
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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
mouth
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)
Not Found
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
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic. The text is in all caps and appears to be a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 8 2000
Mr. Jeff Rassoli President DiamoDent, Inc. 695 South Morningstar Drive Anaheim, California 92808
Re : K993129 UCLA/Universal Abutments Trade Name: Regulatory Class: III Product Code: DZE Dated: December 21, 1999 Received: December 28, 1999
Dear Mr. Rassoli:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
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Page 2 - Mr. Rassoli
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4690. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Patricia Cieciente/Abr
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K993129
Device Name: UCLA/Universal Abutments, Impression Posts, Implant Analogs, Cement Retained Abutments, Temporary Abutments, Tools, and Accessories.
Indications for Use:
- . Universal and UCLA Abutments are used as patterns for casting of prostheses. The prosthesis (restoration) will be fastened directly to implant by using a screw.
- Impression Posts are used to register the location and position of the implants in mouth.
- Implant Analogs are replicas of the implants and are mounted in stone model.
- . Cement Retained Abutments are used when the abutment is being used as substructure and the crown is attached on it by using dental cement.
- Temporary Abutments are used while the prostheses are being made. This abutment will be used for a short time. A resin material such as Acrylic will be attached to it directly or by cement.
- Tools and Accessories, such as screwdrivers are used to screw in or tighten the screws, coping screw and housing are used to screw retain the coping on the prosthesis. Drill and reamer are used to smooth out the inner surfaces of abutments after casting.
All Universal, UCLA, Cement Retained and Temporary Abutments, Implant Analogs and Impression Posts are compatible and will be used with Branemark Regular Platform (RP) implants from Nobel Biocare, which have 2.70mm external hexagon and 2mm thread. All abutments will be used for fully or partially edentulous and/or for single tooth dental prostheses.
YULL Ln MSR
ivision of Dental. Infection Co. and General Hospital Devices 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ﺳﻨﺔ (Per 21CFR 801.109)
OR
Over-The-Counter Use