(83 days)
Not Found
No
The description focuses on the physical properties and intended use of a thermoplastic impression material, with no mention of AI or ML.
No
The device is described as an impression material for dental use, not for treating or curing a disease or condition.
No
The device is described as an "impression material" used for creating impressions, not for diagnosing medical conditions. Its intended use focuses on physical impressions for dentures, root surfaces, and posts, which are restorative or preparatory steps, not diagnostic ones.
No
The device description clearly states it is a thermoplastic impression material available in physical forms (cakes and sticks), indicating it 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 for taking impressions of anatomical structures (dentures, root surfaces, posts, etc.) within the body. This is a physical process for creating a mold, not for examining specimens in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a thermoplastic material used for physical impressions. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The description lacks any mention of analyzing blood, urine, tissue, or other biological specimens, which are hallmarks of IVD devices.
Therefore, Impression Compound is a dental impression material used for physical procedures, not an IVD.
N/A
Intended Use / Indications for Use
Impression Compound is intended for use as a rebasing and relining impression material as well as for general impressions including, but not limited to dentures, root surfaces and posts.
Product codes (comma separated list FDA assigned to the subject device)
ELW
Device Description
Impression Compound is a thermoplastic impression material available in cakes for full or partial impressions or in sticks for adding to the periphery of an impression or for copper band impressions. Impression Compound is available in three different working temperatures. The different colors signify the softening temperature of each compound.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
An In Vitro Cytoxicity biocompatibility study has been completed on Impression Compound, which demonstrates that the material is non-cytotoxic and is safe for its intended use. This 510(k) submission also includes data from bench testing used to mitchara the physical properties of Impression Compound compared to the predicate device, ISO Functional.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Based upon the biocompatibility and bench testing, the clinical performance of Impression Compound is deemed to be substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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 logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above the letters. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are written in a smaller, sans-serif font. The logo is black and white.
APR - 5 2011
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7602 - Phone (714) 516-7472 - Facsimile Wendy Garman - Contact Person
Date Summary Prepared: January 2011
Device Name:
- · Trade Name Impression Compound
- · Common Name Impression Material
- · Classification Name Impression Material, per 21 CFR § 872.3660
Device for Which Substantial Equivalence is Claimed:
- · GC America Incorporated, ISO Functional, K022430
Device Description:
Impression Compound is a thermoplastic impression material available in cakes for full or partial impressions or in sticks for adding to the periphery of an impression or for copper band impressions. Impression Compound is available in three different working temperatures. The different colors signify the softening temperature of each compound.
Intended Use of the Device:
Impression Compound is intended for use as a rebasing and relining impression material as well as for general impressions including, but not limited to dentures, root surfaces and posts.
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Substantial Equivalence:
Impression Compound is substantially equivalent to another legally marketed device in the United States. Impression Compound functions in a manner similar to and is intended for the same use as ISO Functional, currently marketed by GC America Incorporated.
An In Vitro Cytoxicity biocompatibility study has been completed on Impression Compound, which demonstrates that the material is non-cytotoxic and is safe for its intended use. This 510(k) submission also includes data from bench testing used to mitchara the physical properties of Impression Compound compared to the predicate device, ISO Functional.
Based upon the biocompatibility and bench testing, the clinical performance of Impression Compound is deemed to be substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The bird is oriented towards the upper right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration · 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SpofaDental C/O Ms. Wendy Garman Director, Regulatory Affairs Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867
APR - 5 2011
Re: K110378 Trade/Device Name: Impression Compound Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: January 10, 2011 Received: January 12, 2011
Dear Ms. Garman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2- Ms. Garman
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
hh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices
Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Impression Compound
Indications For Use:
Impression Compound is intended for use as a rebasing and relining impression material as well as for general impressions including, but not limited to dentures, root surfaces and posts.
Prescription Use _ ਮ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CORP) Office of Device Evaluation (ODE)
Susan Keane
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K110378
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