(85 days)
None
Not Found
No
The summary provides no information suggesting the use of AI or ML, and the intended use (artificial teeth for dentures) is typically a mechanical or material-based application.
No
The device is described as "Used as artificial teeth to produce partial and full dentures," which indicates it is a component for creating dentures, not a device used to treat a disease or condition itself.
No
The device is used to produce artificial teeth (partial and full dentures), which is a treatment or restorative function, not a diagnostic one.
No
The intended use describes artificial teeth for dentures, which are physical devices, not software. The summary lacks information about any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Used as artificial teeth to produce partial and full dentures." This describes a device used in the mouth for prosthetic purposes, not a device used in vitro (outside the body) to examine specimens for diagnostic purposes.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples (blood, urine, tissue, etc.), diagnostic testing, or providing information for diagnosis or treatment decisions based on laboratory results.
Therefore, this device falls under the category of a dental prosthetic device, not an IVD.
N/A
Intended Use / Indications for Use
Used as artificial teeth to produce partial and full dentures.
Product codes
76 ELM
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol. The image is in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Shofu Dental Corporation Mr. David P. Morais Operations Manager and Official Correspondent 1225 Stone Drive San Marcos, California 92078
Re: K121749
Trade/Device Name: Veracia Regulation Number: 21 CFR 872.3590 Regulation Name: Preformed Plastic Denture Tooth Regulatory Class: II Product Code: 76 ELM Dated: June 12, 2012 Received: June 14, 2012
Dear Mr. Morais:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave to row and have determined the device is substantially equivalent (for the referenced above and in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Amendinone, or to act read Cosmetic Act (Act) that do not require approval of a premarket the I cuchal I ood, Drag, and Connents , therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, legallents for unitude regisinst misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your (1 Mrs), it thay be basjevve adde of Federal Regulations, Title 21, Parts 800 to 898. In device can be lound in the Souther announcements concerning your device in the Federal Register.
SEP - 7 2012
1
Page 2- Mr. Morais
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); medical device reporting (reworting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Rumore
Anthony D. Watson, B.S., M.S., M.B.A. 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):
121749 Device Name: VERACIA
Indications For Use:
Used as artificial teeth to produce partial and full dentures.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runnes
X
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospita:
Division of Anesthesiology, General Devices Division of Anesthoolooking on
510(k) Number:
Shofu Dental Corporation VERACIA 510(k) Premarket Notification