(151 days)
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No
The summary describes a dental impression material, which is a physical substance, and there is no mention of software, algorithms, or any computational processing that would involve AI or ML.
No
The device is a dental impression material used to reproduce dental structures for study models and prosthetic device production, which are diagnostic and fabrication purposes, not therapeutic.
No
Explanation: The ELITE IMPLANT is described as a dental impression material used to reproduce the structure of teeth and create models for study and prosthetics. While its radiopacity aids in detecting residual fragments, this function is for material detection, not for diagnosing medical conditions or diseases.
No
The device description clearly states it is a "radiopaque dental impression material," which is a physical substance, not software.
Based on the provided information, the ELITE IMPLANT device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- ELITE IMPLANT's Intended Use: The intended use of ELITE IMPLANT is to reproduce the structure of a dental patient's teeth for creating models and prosthetic devices. This is a physical process performed directly on the patient's teeth, not a test on a biological sample.
- Lack of Biological Sample Analysis: The description does not mention any analysis of biological samples.
Therefore, ELITE IMPLANT falls under the category of a dental device used for impression taking, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ELITE IMPLANT is a radiopaque dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a dental patient's teeth. Additionally, it is intended to provide models for study and for the production of restorative prosthetic devices, such as dental inlays and onlays. Its radiopacity is intended to assist in detecting possible fragments of residual material.
Product codes
ELW
Device Description
Radiopaque dental impression material.
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
Teeth (dental)
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.
JUL 1 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ZHERMACK S.P.A. c/o Mr. Gerald W. Shipps, Regulatory Affairs Consultant Cascades Device Consulting Associates 19379 Blue Lake Loop Bend. Oregon 97702
Re: K050417
Trade/Device Name: Elite Implant Regulation Number: 21 CFR 872.3660 Regulation Name: Impression material Regulatory Class: II Product Code: ELW Dated: June 08, 2005 Received: June 09, 2005
Dear Mr. Shipps:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed four beeemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enates, 1976, the enactment date of the Medical Device Amendments, or to conimered provision of ridge in accordance with the provisions of the Federal Food, Drug, de nees that have been that do not require approval of a premarket approval application (PMA). and Cosmetter For (110) and the device, subject to the general controls provisions of the Act. The I ou may, cherefore, mains of the Act include requirements for annual registration, listing of general controll profice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is elaboried (see as coltrols. Existing major regulations affecting your device can may be subject to back access Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Shipps
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri s lossantes or our device complies with other requirements of the Act that TDA has made a dolorimiations administered by other Federal agencies. You must of any reach statutes and regarments, including, but not limited to: registration and listing (21 comply with an the 10th strequirements, and manufacturing practice requirements as set CFK Fart 807), labeling (21 OF R Part 820); and if applicable, the electronic forum in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Seting your device as described in your Section 510(k) I mis letter will anow you to begin mailiering of substantial equivalence of your device to a legally premarket notification: The PDF imaling sification 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), please If you desire specific acries is. Jose (240) 276-0115. Also, please note the regulation entitled, Colliact the Office of Complanse in (21 the Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other gelleral information on your response at its toll-free number (800) 638-2041 or Manufacturers, International and Occess http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Quls
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
··
510(k) Number (if known): K050417
Device Name: ELITE IMPLANT
Indications for Use:
ELITE IMPLANT is a radiopaque dental impression material intended to be placed on a preformed impression tray and used to reproduce the structure of a dental patient's teeth. Additionally, it is intended to provide models for study and for the production of restorative prosthetic devices, such as dental inlays and onlays. Its radiopacity is intended to assist in detecting possible fragments of residual material.
×
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
تحت ترته بعد به
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rsbete DDS for Dr. S. Runner
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:
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