(97 days)
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No
The summary describes a dental implant, a physical device, and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended to replace missing tooth roots and become an osseointegrated prosthesis, directly treating a physiological condition (missing teeth).
No
Explanation: The provided text describes the "Altiva Immediate Function Dental Implant" which is designed to replace missing tooth roots and function as an osseointegrated prosthesis. There is no information suggesting it is used to diagnose a medical condition.
No
The device description and intended use clearly describe a physical dental implant, which is a hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states the device is a "Dental Implant" intended to "replace missing tooth roots." This is a surgical implant placed directly into the body, not a device used to test samples outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic testing.
Therefore, the Altiva Immediate Function Dental Implant is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Altiva implant sizes are for widths 3.3mm, 4.00mm, and 5.00mm. All widths come in lengths of 10mm, 11.5mm, 13mm and 15mm.
Altiva implants are indicated to replace missing tooth roots for single tooth, partial tooth and fully edentulous patients. The Altiva implants can be placed with or without tissue reflection.
The Altiva Implant System is designed to become an osseointegrated prostheses allowing the attachment of partial or complete prosthodontic appliances. The Altiva Implant is designed to be placed in immediate function with a temporary.
All components are to be used as labeled. Components are not intended to be bent by the clinician.
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
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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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three lines representing its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 1 1999
Robert S. Ura, DDS Imcor 8000 West 78th Street, Suite 115 ਦ ਦੇ ਕੇ ਤੇ ਰ Edina, MN
Re: K992512 Altiva Immediate Function Dental Implant Trade Name: Requlatory Class: III Product Code: DZE Dated: July 26, 1999 Received: July 27, 1999
Dear Dr. Ura:
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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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
1
Paqe 2 - Dr. Ura
obligation you might have under sections 531 through 542 of obligation you mags 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) 594-4692. 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 premarket notification" (21 CFR 807.97). 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,
Timothy A. Ulatowski
Director
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): K992512
Altiva Immediate Function Dental Implant Device Name:
Indications For Use:
The Altiva implant sizes are for widths 3.3mm, 4.00mm, and 5.00mm. All widths come in lengths of 10mm, 11.5mm, 13mm and 15mm.
Altiva implants are indicated to replace missing tooth roots for single tooth, partial tooth and fully edentulous patients. The Altiva implants can be placed with or without tissue reflection.
The Altiva Implant System is designed to become an osseointegrated prostheses allowing the attachment of partial or complete prosthodontic appliances. The Altiva Implant is designed to be placed in immediate function with a temporary.
All components are to be used as labeled. Components are not intended to be bent by the clinician.
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _
(Per 21 CFR 801-109)
OR
(Division Sign-Off)
and General Hospita 510(k) Number
Over-The-Counter Use
Susan Russo
Division of Dental, Infection Control,
(Optional Format 1-2-96)