(44 days)
Not Found
Not Found
No
The summary describes a dental impression material, which is a physical substance, and there is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is a dental impression material used to reproduce the structure of teeth, not intended for treating or diagnosing any medical condition.
No
The device is an impression material used to reproduce the structure of teeth and dentures, not to diagnose a condition. It provides a physical model, not information for diagnosis.
No
The device is described as 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 reproduce the structure of a patient's teeth, inlays, and dentures using a dental impression material. This is a physical process for creating a mold or model.
- Lack of Diagnostic Purpose: The description does not mention any diagnostic purpose. It's not used to test samples from the human body to provide information for diagnosis, monitoring, or treatment decisions.
- No Mention of Biological Samples: The process involves taking an impression of the teeth, not analyzing biological samples like blood, urine, or tissue.
IVDs are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This device is a material used on the human body to create a physical representation.
N/A
Intended Use / Indications for Use
Zhermack HYDROGUM 5 is a dental impression material intended to be placed on a preformed tray and used to reproduce the structure of a patient's teeth, inlays and onlays, and surrounding tissue accurately. It is also intended to provide models for dental inlays and dentures.
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, inlays and onlays, and surrounding tissue
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 a partial view of the seal for the U.S. Department of Health and Human Services. The seal includes the department's name encircling a symbol. The symbol is a stylized representation of three human figures, possibly representing the department's focus on people and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 5 2005
Zhermack SpA C/O Mr. Gerald W. Shipps Regulatory Affairs Consultant Cascades Device Consulting Associates 19379 Blue Lake Loop Bend, Oregon 97702
Re: K051424
Trade/Device Names: Hydrogum 5 Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: May 28, 2005 Received: June 10, 2005
Dear Mr. Shipps:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(K) prematics is substantially equivalent (for the indications for referenced above and nave determined the devices marketed in interstate comments, or to devices that use stated in the enclosure) to legally man closed president weeks, or to devices that prior to May 28, 1976, the enactinent call of the Federal Frod. Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Federal PMA). You may have been reclassified in accordance with the provisition (PMA). You may,
Act (Act) that do not require approval of a premarket approval application of the general Act (Act) that do not require approval of a prematics apple was are and consistence of the general
therefore, market the device, subject to the general controls provisions of therefore, market the device, subject or the generalion, list one pal registration, listing of devices, good
controls provisions of the Act include requirements for and adult controls provisions of the Act mortale requiritions against misbranding and adulteration.
In and adulting practice, labeling, and prohibitions against misbranding and adulter
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) mo Enist ensure regulations affecting your device can be may be subject to such additional Controls. Έλληνας καθώς το 898. In addition, FDA may publish
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. found in the Code of Federal resgandone in the Federal Register.
1
Page 2 – Mr. Gerald W. Shipps
Please be advised that FDA's issuance of a substantial equivalence determination does not mean
ts of the Actively and start and stars and with other requirements of the Act Please be advised that FDA is issuance of a substantial equites with other requirements of the Act or
that FDA has made a determination that your device complies. You must that FDA has made a determination that your device collection one requires. You must comply with
any Federal statutes and regulations administed by other Federal and listing any Federal statutes and regulations administed to registration and listing (21 CFR Part 807);
all the Act's requirements, including, but the requirement as set forth in the all the Act's requirements, including pur not in its reguirements as set forth in the quality
labeling (21 CFR Part 801); good manufacturing practice requirements as set fort labeling (21 CFR Part 801); good manufacturing (2 acciocale, the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic pro systems (QS) regulation (21 CFR Fart 620), and 217 -
This letter will allow you to begin marketing your device as described in your Section 510(k)
This and the submittee The TD to be of exhatential equivalence of your device t This letter will allow you to begin marketing your active of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalevice and premarket notification. The FDA finding of substantial equivation of your device to
marketed predicate device results in a classification for your device and thus, permits yo proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
r (1) (1) (1) (1) (1) (1) (1) (115 - Also, please note the regulation ent If you desire specific advice for your device on our laoming nease not the regulation entitled,
contact the Office of Compliance at (240) 276-0115. Also, please note the reg contact the Office of Compliance at (240) 270-0113 - 1135) 2019 - You may obtain other
"Misbranding by reference to premarket notification" (21 CFR Part Rott, of Small "Misbranding by reference to premaintities under the Act from the Division of Small
general information on your responsibilities under the Act from the 1800) 63 general information on your responsibilities ultici increase and of the even of the enember (800) 638-2041 or
Manufacturers, International and Consumer Assistance as isstemi Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.
Sincerely yours,
Suvite y. Michui.Om.D.
Chiu S. Lin, PhI Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image shows the logo for "Zhermack, The Masters in Dentistry". The logo is black and white. The word "Zhermack" is in a bold, sans-serif font, and the words "The Masters in Dentistry" are in a smaller, cursive font below the main word.
Image /page/2/Picture/1 description: The image shows three logos. The first two logos are octagons with the letters "TUV" in the center. The first logo also has the letters "GS" at the top and the numbers "537 1304" at the bottom. The second logo has a leaf at the top and the numbers "ES 14001" at the bottom. The third logo is the FDA logo with the words "U.S. Food and Drug Administration" and the registration number "Reg No. 9027802".
2-Indications for Use
510(k) Number (if known): K051424
Hydrogum 5 Device Name:
Indications for Use:
Zhermack HYDROGUM 5 is a dental impression material intended to be placed on a preformed to provide models Zhermack HYDROGUM 5 is a delliarimpression interiestly. It is also intended to provide models
tray and used to reproduce the structure of a patients teeth, inlays and y and used to reproduce the stucture of a patient of outletted in as dental inlays and dentures.
AND/OR Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Robert S. Betz DDS for Dr. Susan Runner
Division Si Division of Anesthesiology, General Hospital, Infection Control, De
510(k) Number: K051434
Zhermack SpA • Via Bovazecchino, 100 • 45021 Badia Polesine (Rovigo) italy Zhermack SpA • Via Bovazecchino, 100 • 4502 • 4562 • Badria • Brooma (10 • 39)
Tel. +39 0425 597 611 • Fax +39 0425 53 596 • info@zhermack.com • www.zhermack.com