(75 days)
Not Found
No
The summary describes a dental bonding agent and its physical properties and performance, with no mention of AI or ML.
No.
The device is a bonding agent used for intra-oral repair of dental composite restorations, which is a restorative rather than therapeutic function.
No
Explanation: The device is a material for repairing dental composite restorations, not for diagnosing conditions.
No
The device description clearly states it is a "material" and a "bonding agent," which are physical substances, not software.
Based on the provided information, the Ecusit Composite Repair device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "intra-oral repair of dental composite restorations." This is a direct application within the body (intra-oral) for a therapeutic or restorative purpose.
- Device Description: The description confirms it's a "light-curing bonding agent specifically developed for use in intra-oral repair." This reinforces its use within the mouth.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a condition, analyze a sample from the body (like blood, urine, or tissue), or provide information about a patient's health status. IVDs are used for diagnostic purposes.
Therefore, the Ecusit Composite Repair is a dental restorative material used directly on the patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Ecusit Composite Repair is indicated for intra-oral repair of dental composite restorations.
Product codes
KLE
Device Description
The Ecusit Composite Repair material is a single-component, methyl methacrylate-based, light-curing bonding agent specifically developed for use in intra-oral repair of poor or damaged dental composite restorations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intra-oral
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)
Substantial equivalence for this device was based on similarities in design and performance characteristics as well as performance testing. The materials, performance specifications and essential design characteristics of the Ecusit Composite Repair are equivalent to those of the predicate devices. In addition, shear strength and composite penetration depth data were presented for the Ecusit Composite Repair material.
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
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
NOV - 9 1999
510(k) Summarv
| Trade Name: | Ecusit Composite Repair |
|---|---|
| Sponsor: | DMG USA, Inc. |
| 414 South State Street | |
| Dover, DE 19901 | |
| Registration # not yet assigned | |
| Device Generic Name: | Resin tooth bonding agent |
| Classification: | According to Section 513 of the Federal Food, Drug, and |
| Cosmetic Act, the device classification is Class II. |
The proposed Ecusit Composite Repair is substantially equivalent Predicate Devices: to the One Coat Bond Dentin/Enamel Adhesive System marketed by Coltene/Whaledent, Inc., which was cleared for marketing by FDA in K974906.
Product Description:
The Ecusit Composite Repair material is a single-component, methyl methacrylate-based, light-curing bonding agent specifically developed for use in intra-oral repair of poor or damaged dental composite restorations.
Indications for Use:
Ecusit Composite Repair is indicated for intra-oral repair of dental composite restorations.
Safety and Performance:
Substantial equivalence for this device was based on similarities in design and performance characteristics as well as performance testing. The materials, performance specifications and essential design characteristics of the Ecusit Composite Repair are equivalent to those of the predicate devices. In addition, shear strength and composite penetration depth data were presented for the Ecusit Composite Repair material.
Conclusion:
Based on the indications for use, technological characteristics, and comparison to predicate devices, the Ecusit Composite Repair has been shown to be safe and effective for its intended use.
1
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, stacked on top of each other.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 9 1999
DMG USA, Incorporated c/o Ms. Pamela Papineau Consultant to DMG USA, Incorporated Delphi Medical Device Consulting 5 Whitcomb Avenue Ayer, MA 01432
K992879 Re : Ecusit Composite Repair Trade Name: Regulatory Class: I Product Code: KLE Dated: Auqust 16, 1999 Received: Auqust 26, 1999
Dear Ms. Papineau:
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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੈ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug 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
2
Page 2 - Ms. Papineau
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 regulations.
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 labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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.gov/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
3
Page 1 of
510(k) Number (if known): _K 9 92879
Device Name: Ecusit Composite Repair
Indications for Use:
Ecusit Composite Repair is indicated for intra-oral repair of composite restorations.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the -Counter Use __
Susan Ruanu
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital I
510(k) Number
900010