(33 days)
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No
The summary describes a dental try-in paste for color matching, with no mention of AI, ML, image processing, or any computational analysis.
No
The device is described as "color matching shades for use prior to placing Permalute Composite/Restorative Luting Resin" and facilitates "a close approximation of the final bonded outcome but in a water soluble reversible manner." This indicates it's a diagnostic or preparatory tool, not one that directly treats or prevents a disease or condition.
No
Explanation: The device is a try-in paste used for color matching prior to placing a luting resin. Its purpose is to simulate the final bonded outcome in a reversible manner, which is a preparatory step for a restorative procedure, not a diagnostic one.
No
The device description clearly states "Permalute Try-In Paste," indicating a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for color matching shades prior to placing a dental luting resin. This is a procedural aid for a dental restoration process.
- Device Description: It's described as a "Try-In Paste."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVDs are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Permalute try-In Pastes are color matching shades for use prior to placing Permalute Composite/Restorative Luting Resin. Permalute Try-In Pastes facilitate a close approximation of the final bonded outcome but in a water soluble reversible manner.
Product codes
EBF
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Chester McCoy Requlatory Affairs & Quality Assurance Manager Ultradent Products, Incorporated 505 West 10200 South South Jordan, Utah 84095 JUN 24 1997
K971898 Re : Trade Name: Permalute, Try-In Paste Requlatory Class: II Product Code: EBF Dated: May 12, 1997 May 22, 1997 Received:
Dear Mr. McCoy:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic
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Page 2 - Mr. McCoy
Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally . _ 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 fo
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Patricia Cuenca flor
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| ristian provinsioner in the finalisment of the finalisment of the finish of the first for the first for the first for the first for the first for the first for the first for | 1 |
|---|---|
| - |
510(k) Number (if known):
Device Name: _Permalute Try-In Paste =========================================================================================================================================
Indications For Use:
Permalute try-In Pastes are color matching shades for use prior to placing Permalute Composite/Restorative Luting Resin. Permalute Try-In Pastes facilitate a close approximation of the final bonded outcome but in a water soluble reversible manner.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runner
| (Division Sign-Off) | |
|---|---|
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| 510(k) Number | K971898 |
Prescription Use_ V ___(Per 21 CFR 801.109) OR
Over-The-Counter Use_
(Optional Format 1-2-96)