(51 days)
Not Found
No
The 510(k) summary describes a chemical wax remover used in denture fabrication and repair, with no mention of AI or ML technology.
No
The device is used to remove wax and aid in adhesion of acrylic resins for denture fabrication and repair, which falls under dental laboratory procedures rather than directly treating a disease or condition in a patient.
No
The device is used to remove wax from dental resin substructures and aid in adhesion, which are fabrication processes, not diagnostic purposes.
No
The device description clearly states it is a "WAX REMOVER" and an "accessory" to a "Prosthetic Resin System," indicating a physical product used in the fabrication and repair of dental prostheses, not a software-only device.
Based on the provided information, the ECLIPSE® WAX REMOVER is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- ECLIPSE® WAX REMOVER's Function: The description clearly states that the ECLIPSE® WAX REMOVER is used as an accessory in the fabrication, repair, and relining of dentures, appliances, and prostheses. It's used to remove wax from cured resin substructures and aid in adhesion.
- No Specimen Analysis: There is no mention of this device being used to analyze any biological specimens from a patient. Its function is purely related to the manufacturing and maintenance of dental prosthetics.
Therefore, the ECLIPSE® WAX REMOVER falls under the category of a dental device used in the creation and repair of medical devices (dentures, etc.), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ECLIPSE® WAX REMOVER is used as an accessory to Eclipse® Prosthetic Resin System to remove wax and aid in adhesion to other acrylic resins in (1) the fabrication of dentures, appliances, and prostheses; (2) repair of dentures, and prostheses; and (3) relining of denture surfaces.
Product codes
EBI
Device Description
The ECLIPSE® WAX REMOVER is an accessory to the Trubyte® Denture Base Resin System (Eclipse® Prosthetic Resin System). It facilitates the effective removal of wax from cured Eclipse® resin substructures and promotes adhesion to other acrylic resins.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Reference Device(s)
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)
Not Found
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.
0
JUL 2 8 2006
510(k) SUMMARY
DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872
| CONTACT: | Helen Lewis |
|---|---|
| DATE PREPARED: | June 2, 2006 |
| TRADE OR PROPRIETARY NAME: | ECLIPSE WAX REMOVER |
| CLASSIFICATION NAME: | Denture relining, repairing, or rebasing resin, |
| 872.3760 | |
| PREDICATE DEVICES: | Trubyte Denture Base Resin System, K011560 |
DEVICE DESCRIPTION:
The ECLIPSE® WAX REMOVER is an accessory to the Trubyte® Denture Base Resin System (Eclipse® Prosthetic Resin System). It facilitates the effective removal of wax from cured Eclipse® resin substructures and promotes adhesion to other acrylic resins.
INTENDED USE:
The ECLIPSE® WAX REMOVER is used as an accessory to Eclipse® Prosthetic Resin System to remove wax and aid in adhesion to other acrylic resins in (1) the fabrication of dentures, appliances, and prostheses; (2) repair of dentures, and prostheses; and (3) relining of denture surfaces.
TECHNOLOGICAL CHARACTERISTICS:
All of the components found in ECLIPSE® WAX REMOVER have been used in legally marketed devices and/or were found safe for dental use. ECLIPSE® WAX REMOVER has been evaluated and passed biocompatibility testing for cytotoxicity.
We believe that the prior use of the components of ECLIPSE® WAX REMOVER in legally marketed devices, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of the ECLIPSE® WAX REMOVER for the indicated use.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 8 2006
DENTSPLY International. Incorporated Ms. Helen Lewis Director of Corporate Compliance & Regulatory Affairs Dentsply Prosthetics Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872
Re: K061580
Trade/Device Name: ECLIPSE® WAX REMOVER Regulation Number: 872.3760 Regulation Name: Denture Relining, Repairing or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: June 2, 2006 Received: June 7, 2006
Dear Ms. Lewis:
We have reviewed vour 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting vour 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 - Mr. Lewis
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); 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.
This letter will allow you to begin marketing your device as described in your Section 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 labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/edrh/industry/support/index.html.
Sincerely yours.
Chiu Lin. Ph.D.
[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): K061580
ECLIPSE® WAX REMOVER Device Name:
Indications for Use:
The ECLIPSE® WAX REMOVER is used as an accessory to Eclipse® Prosthetic Resin System to remove wax and aid in adhesion to other acrylic resins in (1) the fabrication of dentures, appliances, and prostheses; (2) repair of dentures, and prostheses; and (3) relining of denture surfaces.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) ANDIOR
Over-The-Counter Use __ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE —CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert S. Betz DDS for Dr. Susan Renner