(85 days)
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No
The description details a traditional dental impression material and process, with no mention of software, algorithms, or AI/ML terms.
No.
The device is an impression material used to create a model for crowns or bridges, not to treat a disease or condition itself.
No
Explanation: The device is an "Impression Material" used to take a physical impression of teeth for the purpose of creating crowns or bridges. It does not analyze patient data or provide medical insights for diagnosis.
No
The device description explicitly states "Impression Material," which is a physical substance, not software. The intended use also describes a physical process involving mixing and placing material.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use of this device is to take an impression of prepared teeth in the mouth. While the impression is used to create a model for further work, the device itself is used directly on the patient's teeth, not on a specimen taken from the body.
- The purpose of an IVD is to provide information about a physiological or pathological state. This device is used to create a physical mold of teeth for the purpose of fabricating a dental restoration (crown or bridge). It does not provide diagnostic information about the patient's health.
The description clearly indicates a device used for a dental procedure (taking an impression for a crown or bridge), which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
For use in taking the final Impression of prepared teeth in adult or deciduous teeth when the dentist has determined that a crown or a bridge is needed. The dentist examines the patient and determines the need for a crown or bridge. They then prepare the teeth or tooth in their usual manner. The two component impression material is then mixed manually or automatically and placed into an impression tray of the dentists' choosing. The material is then placed in the mouth and allowed to set, approx. 4 minutes, resulting in an impression of the prepared teeth. The resulting impression is then disinfected and a model is poured from this impression for use by the dentist or dental lab in preparation of the crown or bridge that is to be constructed.
Product codes
EZW
Device Description
Impression Material
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
prepared teeth
Indicated Patient Age Range
adult or deciduous teeth
Intended User / Care Setting
dentist or dental lab
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
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§ 872.3660 Impression material.
(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure with three arms or lines extending upwards, representing health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 9 1998
Mr. Edward Spehar ·Lone Star Technologies® (LST) 31 Runnymeade Road Chatham, New Jersey 07928
K980968 Re : Lone Star Impression Systems Trade Name: Requlatory Class: II Product Code: EZW Dated: March 12, 1998 Received: March 16, 1998
Dear Mr. Spehar:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the merice 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). You may, therefore, market the device, subject to the general The general controls controls provisions of the Act. 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 (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. ਰ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. 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. Spehar
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) 594-4692. 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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director
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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510(k) NUMBER (IF KNOWN)K980968
Impression Material DEVICE NAME:
INDICATIONS FOR USE:
For use in taking the final Impression of prepared teeth in adult or deciduous teeth when the dentist has determined that a crown or a bridge is needed. The dentist examines the patient and determines the need for a crown or bridge. They then prepare the teeth or tooth in their usual manner. The two component impression material is then mixed manually or automatically and placed into an impression tray of the dentists' choosing. The material is then placed in the mouth and allowed to set, approx. 4 minutes, resulting in an impression of the prepared teeth. The resulting impression is then disinfected and a model is poured from this impression for use by the dentist or dental lab in preparation of the crown or bridge that is to be constructed.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANCTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) the text is:
510(k) Number