(81 days)
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No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device is described as radiopaque denture teeth used for planning implant placement, which is a passive, non-computational function.
No
The device is used for determining the placement, location, and angulation of dental implants, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is used for "determining the future placement, location and angulation of dental implants," which involves assessing and identifying a condition or characteristic for medical purposes, fitting the definition of a diagnostic device.
No
The device description explicitly states "SR VivoTAC, Modifier Monomer & Polymer," indicating physical components (denture teeth and associated materials), not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to determine the placement, location, and angulation of dental implants using radiopaque denture teeth. This is a diagnostic aid for a medical procedure (dental implant placement), not a test performed in vitro on biological samples to diagnose a disease or condition.
- Device Description: The device is described as radiopaque denture teeth and related materials. This aligns with a medical device used in a clinical setting, not an IVD which typically involves reagents, calibrators, controls, and instruments for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes (biomarkers, pathogens, etc.)
- Diagnosis, monitoring, or prognosis of a disease or condition based on in vitro testing.
Therefore, the SR VivoTAC/SR OrthoTAC device, as described, falls under the category of a medical device used in dentistry, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
SR VivoTAC/SR OrthoTAC are radiopaque denture teeth intended to be used for determining the future placement, location and angulation of dental implants. The decemining the rature placements to se utilized to lengthen the cervical region so that the entire length of the tooth can be made of radiopaque material. .
Product codes
ELM
Device Description
SR VivoTAC, Modifier Monomer & Polymer is the trade/device name. SR VivoTAC/SR OrthoTAC are radiopaque denture teeth.
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
Dental implants
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.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 872.3590 Preformed plastic denture tooth.
(a)
Identification. A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized eagle or bird-like symbol with three curved lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is in black and white.
Public Health Service
Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850
Ms. Donna Marie Hartnett Assistant Corporate Counsel Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228
Re: K023035
Trade/Device Name: SR VivoTAC, Modifier Monomer & Polymer Regulation Number: 872.3590 Regulation Name: Preformed Plastic Denture Tooth Regulatory Class: II Product Code: ELM Dated: September 9, 2002 Received: September 12, 2002
Dear Ms. Hartnett:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Hartnett
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4613. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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K023035 510(k) Number (if known):
Device Name:
SR VivoTAC/SR OrthoTAC, Modifier Monomer & Polymer
Indications For Use:
SR VivoTAC/SR OrthoTAC are radiopaque denture teeth intended to be used for determining the future placement, location and angulation of dental implants. The decemining the rature placements to se utilized to lengthen the cervical region so that the entire length of the tooth can be made of radiopaque material. .
(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
Over-The-Counter Use
(Optional Format 1-2-96)
unrol (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
Unter
510(k) Number: K022303