(46 days)
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No
The summary describes a dental impression material, a physical substance, with no mention of software, algorithms, or any technology that would incorporate AI/ML.
No
The device is used to make dental impressions, which are then used to create plaster models of teeth. It does not provide any therapy or treatment for a disease or condition.
No
The device is described as an impression material used to make dental impressions, which are then used to create plaster models of teeth. Its purpose is to create a physical mold, not to diagnose a condition or disease.
No
The device is a dental impression material, which is a physical substance, 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 make dental impressions for creating plaster models of teeth. This is a physical process for creating a mold, not a diagnostic test performed on a biological sample in vitro (outside the body).
- Device Description: The device is a dental impression material.
- Lack of Diagnostic Activity: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This dental putty does not fit that description.
N/A
Intended Use / Indications for Use
Elite H-D putties are thick, vinyl polysiloxane dental impression materials intended to be used in conjunction with more fluid vinyl polysiloxane impression materials in order to make dental impressions. The resulting impressions are used to make plaster models of the teeth.
Product codes
ELW
Device Description
Elite H-D Vinyl Polysiloxane Impression Materials - Putty Soft/Normal Setting & Fast Setting
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 (dental impressions)
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/0 description: The image shows a black and white logo for the Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with a winding snake around a staff. The text "DEPARTMENT OF HEALTH & HUMAN" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Evan Dick, Ph.D. President Zhermack S.P.A. C/O E.G. Dick & Associates 7527 Westmoreland Avenue St. Louis, Missouri 63105
Re: K972239 Trade Name: Elite H-D Vinyl Polysiloxane Impression Materials - Putty Soft/Normal Setting & Fast Setting Regulatory Class: II Product Code: ELW Dated: June 16, 1997 Received: June 16, 1997
AUG - I 1997
Dear Dr. Dick:
【【相】【德德登】 张】【 】【
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, 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. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical
1
General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Druq 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 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 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 labelinq regulation (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 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.qov/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
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INDICATIONS FOR USE STATEMENT
510(k) Number: K972239
Device Name:
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Elite H-D Vinyl Polysiloxane Impression Materials
- · Putty Soft / Normal Setting
· Putty Soft / Fast Setting
Indications For Use:
Elite H-D putties are thick, vinyl polysiloxane dental impression materials intended to be used in conjunction with more fluid vinyl polysiloxane impression materials in order to make dental impressions.
The resulting impressions are used to make plaster models of the teeth.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Susan Runner | |
|---|---|
| (Division Sign-Off) | |
| Division of Dental, Infection Control, | |
| and General Hospital Devices | |
| 510(k) Number | K972239 |
| Prescription Use | OR | Over-The-Counter Use | |
|---|---|---|---|
| (per 21 CFR 01.109) |
(Optional Format 1-2-96)