(55 days)
Not Found
Not Found
No
The 510(k) summary describes a dental restorative material and its properties, with no mention of AI or ML technology. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is a restorative dental material for filling and repairing teeth, not a device used for treating a disease or condition.
No
The device is a dental restorative material used for filling and repairing purposes, not for diagnosing medical conditions.
No
The device description clearly states it is a "light cured, radiopaque flowable compomer dental restorative" which 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 clearly states it's a "dental restorative material" used for filling cavities, repairing defects, and other dental procedures. This is a therapeutic and restorative function performed directly on the patient's teeth.
- Device Description: The description details the material composition and its properties as a dental filling material.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (like blood, urine, or tissue) to diagnose a disease or condition. IVDs are used in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
Therefore, this device falls under the category of a dental restorative material, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The intended use of élan - 2 is for the restoration of Class III and Class V cavities, repair of enamel defects, repair of porcelain restorations, minor occlusal build-ups in low-stress bearing areas, lining cavities, sealing pits and fissures and for block-out of undercuts.
élan - 2 is a light-curable, dental restorative material containing a fluoride releasing agent which is designed to be used as a filling material for Class III and Class V restorations. Additional functions include: Repair of enamel defects, repair of porcelain restorations, minor occlusal build-ups in low-stress bearing areas, pit and fissure sealant, base/cavity liner and blockout of undercuts.
Product codes
EBF
Device Description
The device is a light cured, radiopaque flowable compomer dental restorative combining the desirable properties of a flowable composite resin and a glass ionomer: good mechanical strength and wear resistance, excellent esthetics, easy handling and placement, and long-term fluoride release. This unique flowable compomer utilizes a special acidic aromatic resin containing multi-methacrylate functional groups, which, upon curing, results in an extremely strong and highly wear resistant crosslinked matrix system. It is reinforced with a reactive fluoroaluminosilicate filler (approximately 60%) and fumed silica to provide a flowable, non-slumping restorative material.
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)
Vivadent Ets., Compoglass Flow
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
OCT 2 8 1998
Image /page/0/Picture/1 description: The image shows the logo "sds" in a stylized font with a swoosh above it. To the right of the logo is the handwritten text "KA83091". The text appears to be a serial number or some other type of identification code. The image is in black and white.
SYBRON DENTAL SPECIA
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person
Date Summary Prepared: September 1998
Device Name:
- Trade Name élan 2 .
- Common Name Light-Curable Dental Restorative Material .
- Classification Name Tooth Shade Resin Material, per 21 CFR § 872.3690 ●
Devices for Which Substantial Equivalence is Claimed:
- Vivadent Ets., Compoglass Flow .
Device Description:
The device is a light cured, radiopaque flowable compomer dental restorative combining the desirable properties of a flowable composite resin and a glass ionomer: good mechanical strength and wear resistance, excellent esthetics, easy handling and placement, and long-term fluoride release. This unique flowable compomer utilizes a special acidic aromatic resin containing multi-methacrylate functional groups, which, upon curing, results in an extremely strong and highly wear resistant crosslinked matrix system. It is reinforced with a reactive fluoroaluminosilicate filler (approximately 60%) and fumed silica to provide a flowable, non-slumping restorative material.
Intended Use of the Device:
The intended use of élan - 2 is for the restoration of Class III and Class V cavities, repair of enamel defects, repair of porcelain restorations, minor occlusal build-ups in low-stress bearing areas, lining cavities, sealing pits and fissures and for block-out of undercuts.
Substantial Equivalence:
élan - 2 is substantially equivalent to other legally marketed devices in the United States. The compomer restorative material marketed by Vivadent Ets. functions in a manner similar to and is intended for the same use as the product manufactured by Kerr Dental Materials Center.
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the top. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
OCT 28 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kerr Dental Materials Center C/O Ms. Colleen Boswell Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867
Re : K983091 Trade Name: élan-2 Requlatory Class: II Product Code: EBF Dated: September 2, 1998 Received: September 3, 1998
Dear Ms. Boswell:
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, Drug, 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, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 requlatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. premarket notification submission does not affect any 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.
2
Page 2 - Ms. Boswell
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA debtribut in four four 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
Timo A. Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Section I - Indications for Use
510(k) Number: K983091
Device Name: élan - 2
Indications for Use:
élan - 2 is a light-curable, dental restorative material containing a fluoride releasing agent which is designed to be used as a filling material for Class III and Class V restorations. Additional functions include: Repair of enamel defects, repair of porcelain restorations, minor occlusal build-ups in low-stress bearing areas, pit and fissure sealant, base/cavity liner and blockout of undercuts.
Susan Runner
(Division Sign-Off) Division of Dental, Infecti and General Hospital Device 510(k) Number
Prescription 11
(Per 21 CFR 801.109)