(70 days)
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No
The document describes a flowable composite material for dental restorations and does not mention any AI or ML components.
No.
The 'Intended Use/Indications for Use' section describes dental restoration procedures, such as fillings and veneers, which are restorative rather than therapeutic.
No
Explanation: The device, PermaFlo Flowable Composite, is described as suitable for restorative dental procedures (fillings, inlays, veneers), which are treatments, not diagnostics.
No
The device description clearly identifies the device as "PermaFlo Flowable Composite," which is a material used in dental restorations, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to direct dental restorative procedures (fillings, veneers, luting, etc.). These are procedures performed directly on the patient's teeth.
- Device Description: The device is described as a "Flowable Composite," which is a material used in dental restorations.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVDs are used to perform tests outside of the body on biological samples. This device is used inside the body for direct treatment.
N/A
Intended Use / Indications for Use
PermaFlo can be used for:
-
- Anterior and posterior restorations, such as Class I, II, III, IV, and V.
-
- Luting translucent inlays and onlays. Permalute (chemical cure) is recommended for more opaque or thick inlays/onlays where light cure is not predictable.
-
- Direct veneers and other restorative procedures
-
- Restoring missing subgingival tooth structure prior to endodontic procedures (this is referred to as the "donut" technique).
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)
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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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 2 1998
Mr. Chester McCoy Regulatory Affairs Manager Ultradent Products, Incorporated 505 W. 10200 South South Jordan, Utah 84095
Re : K974413 Trade Name: Permaflo Regulatory Class: II Product Code: EBF Dated: November 20, 1997 November 24, 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 qeneral controls provisions The general controls provisions of the Act 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 (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. A 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 requlatory 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
1
Page 2 - Mr. McCoy
through 542 of the Act for devices under the Electronic 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 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 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 to
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) 63842041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski
Timo waki Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): __Unknown
Device Name: PermaFlo Flowable Composite _____________________________________________________________________________________________________________________________________
Indications For Use:
PermaFlo can be used for:
-
- Anterior and posterior restorations, such as Class I, II, III, IV, and V.
-
- Luting translucent inlays and onlays. Permalute (chemical cure) is recommended for more opaque or thick inlays/onlays where light cure is not predictable.
-
- Direct veneers and other restorative procedures----------------------------------------------------------------------------------------------------------------------------
-
- Restoring missing subgingival tooth structure prior to endodontic procedures (this is referred to as the "donut" technique).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| 510(k) Number | K974413 |
| Prescription Use | Yes |
| (Per 21 CFR 801.109) | |
| OR | |
| Over-The-Counter Use | |
| (Optional Format 1-2-96) |