(67 days)
K932243 HF-2-410 ODE/DGRD
K932243 HF-2-410 ODE/DGRD
No
The 510(k) summary describes a dental bonding material and does not mention any AI or ML components or functionalities.
No.
The device is a bonding agent for dental restorations, not a device used to treat or cure a disease or medical condition.
No
The device is described as a bonding agent for dental restorations, not as a tool to identify or investigate a disease or condition.
No
The device description clearly states it is a "Dental Material," which is a physical substance, not software.
Based on the provided information, the UCP™ Dental Material is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a bonding agent used in the preparation of a Porcelain-Fused-to-Metal-Restoration (PFM) for dental purposes. This is a material used in the mouth to facilitate a physical bond between dental materials.
- 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. The UCP™ Dental Material does not fit this definition.
The device is a dental material used in a restorative procedure, not a diagnostic test performed on a biological sample.
N/A
Intended Use / Indications for Use
The UCP™ Dental Material is used as a bonding agent to facilitate a bond between an opaque porcelain and a gold based metal understructure in the preparation of a Porcelain-Fused-to-Metal-Restoration (PFM). The UCP™ Dental Material is particularly intended for bonding porcelain to a precious metal coping marketed under the trade name "Captek" which received Premarket 510(k) authorization from the FDA in 1994 under the FDA number K932243 HF-2-410 ODE/DGRD.
Product codes
EJT
Device Description
The UCP™ Dental Material is used as a bonding agent to facilitate a bond between an opaque porcelain and a gold based metal understructure in the preparation of a Porcelain-Fused-to-Metal-Restoration (PFM). The UCP™ Dental Material is particularly intended for bonding porcelain to a precious metal coping marketed under the trade name "Captek" which received Premarket 510(k) authorization from the FDA in 1994 under the FDA number K932243 HF-2-410 ODE/DGRD.
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)
K932243 HF-2-410 ODE/DGRD
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3060 Noble metal alloy.
(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with a ribbon-like element flowing beneath them. The profiles are arranged in a way that suggests unity and forward movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the image.
JAN 2 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Eugene Lieberstein, Esq. Secretary Precious Chemicals U.S.A., Incorporated 2151 Long Ridge Road Stamford, Connecticut 06903
Re: K023831
Trade/Device Name: UCP™ Dental Material Regulation Number: 21 CFR 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: November 08, 2002 Received: November 18, 2002
Dear Mr. Lieberstein:
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 - Mr. Eugene Lieberstein, Esq.
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) you may obtain. 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.
Susan Renner
Susan Runner, DDS, MA Interim 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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PRECIOUS CHEMICALS U.S.A., INC Premarket 510(k) Submission UCC™ Dental Material Regulatory Class II
Indication Of Use Statement
The UCP™ Dental Material is used as a bonding agent to facilitate a bond between an opaque porcelain and a gold based metal understructure in the preparation of a Porcelain-Fused-to-Metal-Restoration (PFM). The UCP™ Dental Material is particularly intended for bonding porcelain to a precious metal coping marketed under the trade name "Captek" which received Premarket 510(k) authorization from the FDA in 1994 under the FDA number K932243 HF-2-410 ODE/DGRD.
Kevin Wchey for MSR
nesthesiology, General Ho tion Control, De
510(k) Number: K023831