(18 days)
Not Found
No
The description focuses on the chemical composition and bonding mechanism of the agent, with no mention of AI or ML.
No.
The device is a bonding agent used in the dental laboratory for enhancing the bond of acrylic teeth to acrylic removable denture bases, not for treating a disease or condition in a patient.
No.
The device description clearly states its purpose is to "enhance the bond of acrylic teeth to acrylic removable denture bases" and "forming a strong and lasting bond" between these components. There is no mention of diagnosing conditions, detecting diseases, or providing any form of diagnostic information. It is a bonding agent used in the fabrication of dentures.
No
The device description clearly states it is a "blend of reactive dimers and oligomers in a solvent vehicle," which are chemical components, not software. It is a physical substance used in a dental laboratory.
Based on the provided information, the ECLIPSE® BONDING AGENT is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to enhance the bond of acrylic teeth to acrylic removable denture bases. This is a dental laboratory process for fabricating a medical device (a denture), not a diagnostic test performed on a biological sample to provide information about a patient's health.
- Device Description: The description details a chemical formulation used for bonding materials together. It does not describe a test or assay for detecting substances or conditions in a biological sample.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes (proteins, DNA, chemicals, etc.)
- Providing diagnostic information about a disease or condition
- Use in a clinical setting for patient diagnosis or monitoring
The device is clearly intended for use in a dental laboratory setting by trained technicians for the fabrication of a denture. This falls under the category of a dental material or accessory used in the manufacturing of a medical device.
N/A
Intended Use / Indications for Use
ECLIPSE® BONDING AGENT is indicated for use in enhancing the bond of acrylic teeth to acrylic removable denture bases.
Product codes
KLE, EBI
Device Description
The ECLIPSE® BONDING AGENT is a blend of reactive dimers and oligomers in a solvent vehicle. These reactive entities, once initiated, undergo polymerization across the interface vehicle. This formulation has been shown to be particularly effective in initiating and maintaining the bond between acrylic denture teeth and both pour and light-curable denture base 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
The device is intended for use in the dental laboratory, by trained technicians, for the purpose of enhancing the bond between plastic denture teeth and cured denture base resins.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Trubyte® Denture Bond Denture Bonding Agent, K982007
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.
0
( (
JUL 1 5 2005
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 23, 2005 |
| TRADE OR PROPRIETARY NAME: | ECLIPSE® BONDING AGENT |
| CLASSIFICATION NAME: | Denture relining, repairing, or rebasing resin, 872.3760 |
| PREDICATE DEVICES: | Trubyte® Denture Bond Denture Bonding Agent, K982007 |
DEVICE DESCRIPTION:
The ECLIPSE® BONDING AGENT is a blend of reactive dimers and oligomers in a solvent These reactive entities, once initiated, undergo polymerization across the interface vehicle. vehicle. " These Teactive Chines, once incrawer, and lasting bond. This formulation has been shown to be particularly effective in initiating and maintaining the bond between acrylic denture teeth and both pour and light-curable denture base resins.
The device is intended for use in the dental laboratory, by trained technicians, for the purpose of The device is micondoveen plastic denture teeth and cured denture base resins.
INTENDED USE:
ECLIPSE® BONDING AGENT is indicated for use in enhancing the bond of acrylic teeth to acrylic removable denture bases.
TECHNOLOGICAL CHARACTERISTICS:
The components of ECLIPSE® BONDING AGENT have been used in legally marketed devices The components of ECEA 825 DONDS ever that the prior use of the initiator components in legally marketed devices, the data provided regarding the modifications to the marketed device, legally marketed devices, the data provised togeness of ECLIPSE® BONDING AGENT for the intended 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 body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular fashion around the eagle.
JUL 1 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872
Re: K051707
Trade/Device Name: Eclipse® Bonding Agent Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Codes: KLE and EBI Dated: June 23, 2005 Received: June 27, 2005
Dear Ms. Lewis:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your booked on (-) F referenced 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 nat ( 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 mentrols 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 If your device to such additional controls. Existing major regulations affecting your device can be may of subject to sten adamines, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 -- Ms. Helen Lewis
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 's issuance or a sudstantel other requirements of the Act or
that FDA has made a determination that your device complies. You must comply with that FDA has made a determination that your deviles with benefices. You must comply with any Federal statutes and regulations administed to registration and listing (21 CFR Part 807);
all the Act's requirements, including but not timined to registrations set fort all the Act's requirements, including, but not innited to: regirements as se forth in the quality
labeling (21 CFR Part 801); good manufacturing practice requirements as se f labeling (21 CFR Part 801); good manuacturing (pacciocable, the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic prod systems (QS) regulation (21 CFR-Fall CD), and CDS), and CFF 1000-1050.
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)
The status and the may of a lines of unkstential aquivalence of your device to a This letter will allow you to begin marketing your acence of your device of your device to a legally
premarket notification. The FDA finding of substantial equire and thus premarket notification. The FDA finding of substantial equivalities of your device to
marketed predicate device results in a classification for your device and thus, permits proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
ntitled. If you desire specific advice for your uevice on our accembe the regulation entitled,
contact the Office of Compliance at (240) 276-0115. Also, please note the regulation of contact the Office of Compliance at (240) 270-0113. The Part 807.97). You may obtain other
"Misbranding by reference to premarket notification" (21 CFR Part 807.97). You ma "Misbranding by reference to premail.cc hother the Act from the Division of Small
general information on your responsibilities under the Act from the 1800) 63 general information on your responsibilities uncer in toll-free number (800) 638-2041 or 1 Manufacturers, International and Consumer Assistance at to ver and see and the more in the states of the start
Sincerely yours,
Chiu S. Lin, PhD
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE STATEMENT
0514
510(K) Number (if known):
ECLIPSE® BONDING AGENT Device Name:
Indications for Use:
ECLIPSE® BONDING AGENT is indicated for use in enhancing the bond of acrylic teeth to acrylic removable denture bases.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
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)
Roberts Benz DDS for Dr. Susan Runner
eneral Hospital, Division of Anesthesiology, Infection Control, Dental Devices
510(k) Number: K051707