(43 days)
Not Found
Not Found
No
The summary describes a light-cured resin material, which is a passive material and does not involve any computational processing or algorithms. There are no mentions of AI, ML, image processing, or performance studies related to algorithmic output.
No
This device is a temporary restorative material; it does not treat or cure a disease or condition, but rather mitigates a symptom or condition temporarily.
No
The device is described as a temporary restorative material, which is a therapeutic function, not a diagnostic one. It is used to fill a tooth until a permanent restoration can be placed, not to identify a disease, condition, or state.
No
The device description clearly states it is a "light-cured resin," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, disease or congenital abnormality.
- Device Description and Intended Use: The description clearly states the device is a "light-cured resin intended for use as a temporary restorative material in a tooth". This is a material applied directly to the tooth in vivo (within the body), not used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic purposes, or any of the typical characteristics of an IVD.
Therefore, this device falls under the category of a dental restorative material used directly on the patient, not an IVD.
N/A
Intended Use / Indications for Use
A light-cured resin intended for use as a temporary restorative material in a tooth prepared to receive an inlay or onlay until such time as the laboratory fabricated final restoration can be inserted into that tooth.
Product codes
EBG
Device Description
A light-cured resin intended for use as a temporary restorative material in a tooth prepared to receive an inlay or onlay until such time as the laboratory fabricated final restoration can be inserted into that tooth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth
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)
Fermit N, Tempfil F, Tempfil C&B, Tempfil F-2, LC Provifill.
Reference Device(s)
Not Found
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
SEP = 6 2001
. . . .
PG
:
510(k) SUMMARY
| Submitter: | Parkell, Inc.
155 Schmitt Blvd.
Box 376
Farmingdale, NY 11735
TEL: 631-249-1134
FAX: 631-249-1242 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Nelson J. Gendusa, DDS
Director of Research
Parkell
155 Schmitt Blvd.
Box 376
Farmingdale, NY 11735 |
| Submission Date: | 18 July 2001 |
| Trade Name: | LC Temporary Material |
| Common Name: | Light Cured Temporary Filling Material |
| Classification Name: | Temporary Crown & Bridge Resin |
| Equivalence: | Fermit N, Tempfil F, Tempfil C&B, Tempfil F-2, LC Provifill. |
| Description/Intended Use: | A light-cured resin intended for use as a temporary
restorative material in a tooth prepared to receive an
inlay or onlay until such time as the laboratory fabricated
final restoration can be inserted into that tooth. |
PARKELL INC. • 155 Schmitt Blvd., Farmingdale, NY 11735 USA • 631-249-1134 Toll-Frec 1-800-243-7446 • Fax: 631-249-1242 • E-Mail: info@parkell.com
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure in profile, with three horizontal lines above the head, representing growth and development. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the figure.
Public Health Service
SEP = 6 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nelson J. Gendusa, DDS Director of Research Parkell, Incorporated 155 Schmitt Boulevard P.O. Box 376 Farmingdale, New York 11735
Re: K012360
Trade/Device Name: LC Temporary Filling Regulation Number: 21 CFR 872.3770 Regulation Name: Light-Cured Temporary Filling Materials Regulatory Class: Class II Product Code: EBG Dated: July 18, 2001 Received: July 25, 2001
Dear Dr. Gendusa:
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.
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.
2
Page 2 -- Dr. Gendusa
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,
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page ____ of _________________________________________________________________________________________________________________________________________________________________
Ko 2360 510(k Number (if known):_
Device Name: _LC Temporary Filling
Indications for Use: or onlay until such time as the laboratory fabricated final restoration can be inserted into that tooth.
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(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K012360