(46 days)
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Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other indicators typically associated with AI/ML medical devices. The intended use is for a temporary crown and bridge material, which is a physical material, not a software or imaging-based device.
No
The device is a temporary crown and bridge material, which is a restorative dental material, not a therapeutic device designed for treating diseases or health problems.
No
The "Intended Use / Indications for Use" states "Temporary crown and bridge material," which indicates it is a material for dental restorations, not a device used to diagnose a medical condition.
Unknown
The provided 510(k) summary is incomplete and lacks a device description, making it impossible to determine if the device is software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Temporary crown and bridge material." This describes a material used in the mouth for dental restoration, not a test performed on a sample taken from the body to diagnose a condition.
- Lack of IVD Characteristics: The description lacks any mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
IVDs are specifically designed to be used in vitro (outside the body) to examine specimens from the human body. A temporary crown and bridge material is used in vivo (inside the body) as a restorative dental material.
N/A
Intended Use / Indications for Use
Temporary crown and bridge material
Product codes
EBG
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 (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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three lines forming a stylized bird-like shape. The text "HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 4 2002
J. Morita USA, Incorporated C/O Mr. Keith A. Barritt Fish & Richardson P.C. 601 Thirteenth Street, N.W. Washington, District of Columbia 20005
Re: K020157
Trade/Device Name: Temporary Crown and Bridge Material Regulation Number: 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: January 16, 2002 Received: January 17, 2002
Dear Mr. Barritt:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your becaler be (2) fee is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in indications for use stated in the enviolary to every of the Medical Device interstate colliments, or to thay 20, 1978, 1978, 1978, 1978, 1978, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999, 1999 Amendments, or to devices that have boon formations of require approval of a prematket ine Federal Food, Drug, and Comment , 100 (Schere, market the device, subject to the general approval application (1 Mr.). - 1 Sa . The general controls provisions of the Act include controls provisions of the Fict. "The girling 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 II your device is classified (See as 107 inn a controls. Existing major regulations affecting g (PMA), It may oc subject to Sach adam f Federal Regulations, Title 21, Parts 800 to 898. In your device can oc found in the South In the South of the Federal Register.
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 mean that I DX mas made a abtess and regulations administered by other Federal agencies.
1
Page 2 - Mr. Keith A. Barritt
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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 Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
2
510(k) Number (if known): Device Name: TEMPORARY CROWN AND BRIDGE MATERIAL
Indications For Use:
Temporary crown and bridge material
(DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109)
Susan Rann
(~ivision Sign-Off) (Tivision Sign-On)
Division of Dental, Infection Control,
Division of Dental, Infection Control, Consistal Hospital Pevices =100k) Nomber -