(215 days)
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Not Found
No
The summary describes a dental impression material, which is a physical substance, and contains no mention of software, algorithms, or any technology related to AI/ML.
No
The device is used to take impressions of teeth and gums, which is a diagnostic or preparatory step, not a therapeutic intervention to treat a disease or condition.
No
Explanation: The device is an impression material used to take impressions of teeth and gums for dental appliances, not to diagnose a condition.
No
The device description clearly states "DENTAL ALGINATE IMPRESSION MATERIAL," which is a physical material, 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 take impressions of teeth and gums for the creation of dental appliances. This is a physical process performed directly on the patient's body to create a mold.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not involve testing biological samples.
- Device Description: The description is "DENTAL ALGINATE IMPRESSION MATERIAL," which is a substance used to create a physical mold.
The device is a dental material used for a physical procedure, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
THE DENTAL ALGINATE IMPRESSION MATERIAL IS USED TO TAKE THE PATIENT'S IMPRESSIONS OF TEETH AND GUM WHEN THE PATIENT NEEDS DEVIURE, PARTIAL, OR ANY KINDS OF DENTAL APPLIANCES AND ORTHODONTIC APPLIANCES.
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
TEETH AND GUM
Indicated Patient Age Range
Not Found
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)
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Reference Device(s)
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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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Richard Ting 1510 South Broad Street Philadelphia, Pennsylvania 19146
DEPARTMENT OF HEALTH & HUMAN SERVICES
K970129 Re : Trade Name: Tulip Regulatory Class: II Product Code: ELW Dated: June 27, 1997 Received: July 2, 1997 AUG 1 8 1997
Dear Mr. Ting:
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 of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions aqainst 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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 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. Ting
through 542 of the Act for devices under the Electronic enroagn Siz or on 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 described in your sistir privalence of your device to a legally rinatig of babbeandary of 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) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact che office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference production promotion promotions of the regulation of the regulation information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance obtained from enommer (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 Radioloqical Health
Enclosure
2
K970129 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: __ DENTAL ALGINATE IMPRESSION MATERIAL
Indications For Use:
THE DENTAL ALGINATE IMPRESSION MATERIAL IS JSED TO TAKE THE PATIENT'S IMPRESSIONS OF TEETH AND GUM WHEN THE PATIENT NEEDS DEVIURE, PARTIAL, OR ANY KINDS OF DENTAL APPLIANCES AND ORTHODONTIC APPLIANCES.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Simona Rionay
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use Per 21 CFR 801.109) OR
Over-The-Counter Use No
(Optional Formal 1-2-96)