(181 days)
Not Found
No
The description focuses on a mechanical, air-driven delivery system for dental resin, with no mention of AI or ML components or functionalities.
No
The device is a delivery system for a dental restorative resin, not a device that treats a condition or prevents a disease.
No
The device is described as a dental delivery system used to dispense restorative resin into dental cavities, not to diagnose conditions.
No
The device description clearly details a physical, air-driven dental delivery system with hardware components like a coupling, hose, regulating ring, and a mechanism for attaching cartridges. It is powered by compressed air and controlled by a footswitch. This is not a software-only device.
Based on the provided information, the SONICFill 2010 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "dispense Metamorphosis, a dental restorative resin, directly into dental cavities." This is a direct application of a material to a patient's body for treatment, not for testing or diagnosis of a sample taken from the body.
- Device Description: The description details a delivery system for a dental material, powered by compressed air and controlled by a footswitch. This aligns with a medical device used for a therapeutic procedure, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The SONICFill 2010's function is purely for the delivery of a restorative material during a dental procedure.
N/A
Intended Use / Indications for Use
The SONICFill 2010 is a dental delivery system intended to be used to dispense Metamorphosis, a dental restorative resin, directly into dental cavities.
Product codes
EBF
Device Description
The SONICFill 2010 is an air driven dental delivery system intended to dispense Metamorphosis, a dental restorative resin, directly into dental cavities. The device allows fast and easy extrusion of the composite, which is held in single-dose cartridges (tips). The tips are connected to the device via a screw thread. The device is attached to the dental unit through a coupling and a hose. It is powered via compressed air supplied by the operative unit. The device is switched on and off through the footswitch of the dental unit and the power output can be adjusted through a regulating ring located on the device. The devices can be sterilized by the steam autoclave method.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dental cavities
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
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
sybron dental specialties
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
OCT 1 4 2009
Sybron Dental Specialties, Inc. 1717 West Collins Drive Orange, CA 92656 Claudia Ortiz- Contact Person
October 2009 Date Summary Prepared:
Device Name:
- Trade Name SONICfill 2010 .
- Common Name Tooth shade resin material ●
- Classification Name Material, Tooth Shade, Resin, per 21 CFR § 872.3690 .
Devices for Which Substantial Equivalence is Claimed:
- Produits Dentaires Pierre Rolland, Expasyl Power Applicator(K051933) .
Device Description:
The SONICFill 2010 is an air driven dental delivery system intended to dispense Metamorphosis, a dental restorative resin, directly into dental cavities. The device allows fast and easy extrusion of the composite, which is held in single-dose cartridges (tips). The tips are connected to the device via a screw thread. The device is attached to the dental unit through a coupling and a hose. It is powered via compressed air supplied by the operative unit. The device is switched on and off through the footswitch of the dental unit and the power output can be adjusted through a regulating ring located on the device. The devices can be sterilized by the steam autoclave method.
Intended Use of the Device:
The SONICFill 2010 is a dental delivery system intended to be used to dispense Metamorphosis, a dental restorative resin, directly into dental cavities.
Substantial Equivalence:
The SONICfill 2010 dental delivery system is substantially equivalent to other legally marketed devices in the United States. SONICfill 2010 functions in a manner similar to and is intended for a similar use as the Expasyl Power Applicator marketed by Produits Dentaires Pierre Rolland.
1
Image /page/1/Picture/0 description: The image shows a logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
OCT 1 4 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002
Ms. Claudia Ortiz Compliance Director, Regulatory Affairs & Quality Assurance Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867
Re: K091091
Trade/Device Name: SONICfill 2010 Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: September 22, 2009 Received: September 23, 2009
Dear Ms. Ortiz:
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.
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.
2
Page 2 -- Ms. Ortiz
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 (OS) 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
for
Susan Runner, D.D.S., M.A. Acting 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
510(k) Number (if known):
网 691091
Device Name: SONICfill 2010
Indications for Use:
The SONICFill 2010 is a dental delivery system intended to be used to dispense Metamorphosis, a dental restorative resin, directly into dental cavities.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
:
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Division of Anesthesiology, General Hospital
Infection Control, Dentai Devices
| 510(k) Number: | K091091 |
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