(88 days)
Not Found
Not Found
No
The summary describes a physical retraction cord and does not mention any software, algorithms, or data processing capabilities typically associated with AI/ML.
Yes
The device is used for fixed prosthetic gingival retraction and hemostasis procedures, which are therapeutic interventions.
No
Explanation: The device, Ultrapak E, is described as a retraction cord for gingival retraction and hemostasis procedures. Its function is to facilitate access and control bleeding during dental procedures, not to identify a disease, condition, or provide information for their diagnosis.
No
The device description and intended use clearly describe a physical retraction cord, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used in the mouth for gingival retraction and hemostasis during dental procedures. This is a direct interaction with the patient's body, not an examination of samples outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition based on sample analysis.
- Use in a laboratory setting.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely mechanical and chemical (for hemostasis) within the oral cavity during a dental procedure.
N/A
Intended Use / Indications for Use
Ultrapak E is a retraction cord used for fixed prosthetic gingival retraction and hemostasis procedures; pack after preparation, leave five minutes, remove, and work. For direct restorative procedures, pack prior to bonding and/or restorative placement procedures.
Product codes
MVL
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
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
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is a stylized design featuring a symbol that resembles a caduceus, which is often associated with healthcare. The overall design is simple and professional, reflecting the organization's role in public health and human services.
JUL 31 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Chester McCoy Requlatory Affairs Manager Ultradent Products Incorporated 505 West 10200 South South Jordan, Utah 84095
Re : K981596 Trade Name: Ultrapak E Regulatory Class: Unclassified Product Code: MVL Dated: April 27, 1998 Received: May 4, 1998
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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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
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Page 2 - Mr. McCoy
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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) 594-4692. 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) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A. Autman Jr
Timothy A. Ulatowski Director 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
Ultrapak E Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Ultrapak E is a retraction cord used for fixed prosthetic gingival retraction and hemostasis procedures; pack after preparation, leave five minutes, remove, and work. For direct restorative procedures, pack prior to bonding and/or restorative placement procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_____________ (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
A Ditrom
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
981546 510(k) Number __