(139 days)
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No
The summary describes a dental impression material and catalyst, which are chemical substances, not software or hardware that would typically incorporate AI/ML. There are no mentions of AI, ML, image processing, or data analysis.
No
The device is used to reproduce teeth and gums for models and prosthetic devices, not to treat or cure a disease or condition.
No
Explanation: The device is a dental impression material used to reproduce teeth and gums for models, which are then used for study and production of restorative prosthetic devices. It does not diagnose any condition.
No
The device is a paste catalyst used with a silicone base material, indicating it is a physical substance and 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 to reproduce a patient's teeth and gums for creating models and prosthetic devices. This is a physical process for creating a mold, not a diagnostic test performed on a sample from the body.
- Mechanism of Action: The device is a catalyst that causes a dental impression material to set. This is a chemical reaction for solidification, not a biological or chemical analysis for diagnostic purposes.
- Lack of Diagnostic Information: There is no mention of analyzing a sample (like blood, urine, tissue, etc.) to provide information about a patient's health, disease state, or condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This device does not fit that description.
N/A
Intended Use / Indications for Use
Paste catalyst is used with a condensation-type silicone base paste or putty as a dental impression material to reproduce a patient's teeth and gums, and to provide models for study and for production of restorative prosthetic devices. The paste catalyst causes the base material to set.
Product codes
ELW
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
patient's teeth and gums
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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§ 872.3660 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 3 2000
Ms. Mildred M. Goldstein President Harry J. Bosworth Company 7227 North Hamilton Avenue Skokie, Illinois 60076-3999
Re : K994027 Activator Paste Trade Name: Requlatory Class: II ELW Product Code: March 24, 2000 Dated: Received: April 5, 2000
Dear Ms. Goldstein:
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 able beated in one enouses, 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, Druq, 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 Regulations, Title 21, Parts 800 to 895. ਸੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation 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
1
Page 2 -Ms. Goldstein
premarket notification submission does not affect any obligation you might have under sections 531 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 findinq 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4690. 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,
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
K94027
Page 1 of 1
510(K) Number: K994027
... ...
Device Name: Activator Paste
INDICATIONS FOR USE:
Paste catalyst is used with a condensation-type silicone base paste or putty as a dental impression material to reproduce a patient's teeth and gums, and to provide models for study and for production of restorative prosthetic devices. The paste catalyst causes the base material to set.
(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)
물유용무료보보수속속속속으로부부부부분석으로쓰이용해주세요하십니아바이크사이트♣바둑이해주예약예약===========================================================================================================================
OR Over-the-Counter Use (Optional Format 1/2/96)
CONFIDENTIAL
510(k) Number J
(Division Sign-Off)
Division of Dental, Infection Contra
and General Hospital Devices