(87 days)
No
The device description and performance studies focus on the material properties and mechanical activation of the dental restorative, with no mention of AI or ML.
No
Explanation: A therapeutic device is used to treat or cure a disease or medical condition. SonicFill 2 is a dental restorative material used for filling cavities and repairing dental structures, which is a reconstructive rather than a therapeutic function.
No
Explanation: The device is a dental restorative material used for direct placement in cavities and other dental repairs. Its description and intended use focus on treatment and restoration, not diagnosis.
No
The device description clearly states that SonicFill 2 is a "light-cured, low-shrink, resin-based, dental restorative" and is used in combination with a "SonicFill 2010 Handpiece," indicating it is a physical material and requires a hardware component for activation and delivery.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that SonicFill 2 is a dental restorative material used for direct placement in teeth. It is applied directly to the patient's tooth structure.
- No mention of samples: There is no indication that this device is used to test samples taken from the body.
Therefore, SonicFill 2 is a medical device, specifically a dental restorative material, but it does not fit the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
SonicFill 2 is indicated for direct placement in all cavity classes in anterior teeth. Additional indications include: base/liner material, repair of enamel defects, repair of provisionals, repair of porcelain restorations, minor occlusal build-ups, pit and fissure sealant, luting of composite/ceramic veneers, core build-ups and incisal abrasions.
Product codes (comma separated list FDA assigned to the subject device)
EBF, EBC
Device Description
SonicFill 2 is a light-cured, low-shrink, resin-based, dental restorative designed for direct placement. SonicFill 2 is used in combination with the SonicFill 2010 Handpiece (K091091), which activates the restorative sonically for delivery. Upon delivery the restorative drops in viscosity, allowing the composite to closely adapt to the cavity walls. When the cavity is filled and the SonicFill 2010 Handpiece (K091091) is deactivated, the restorative resin returns to its original viscosity. The composite in the cavity is then shaped and sculpted to the contours of the tooth. SonicFill 2 is designed to have a high depth of cure and low shrinkage stress allowing a cavity up to 5mm in depth to be filled and cured in a single bulk increment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior teeth, anterior and posterior teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Licensed dental professionals
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)
Non-clinical performance data included testing for mechanical strength, polishability, water sorption and solubility, flexural strength, depth of cure, light sensitivity, radiopacity, volumetric shrinkage, shrinkage stress, and color stability. Working Time testing, stability testing and biocompatibility testing were also performed. The data analyzed from the various tests substantiate that SonicFill 2 is as safe and effective as the predicate Metamorphosis (K091023).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Metamorphosis (K091023)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
SonicFill 2010 Handpiece (K091091)
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
§ 872.3690 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
Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, arranged in a way that they appear to be interconnected. The profiles are rendered in black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the profile graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 5, 2015
Sybron Dental Specialties Ms. Kerri Casino Regulatory Affairs Manager 1717 West Collins Avenue Orange, California 92687
Re: K143209
Trade/Device Name: SonicFill 2 Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade resin material Regulatory Class: II Product Code: EBF, EBC Dated: November 7, 2014 Received: November 10, 2014
Dear Ms. Casino:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, 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)
Device Name SonicFill 2
Indications for Use (Describe)
SonicFill 2 is indicated for direct placement in all cavity classes in anterior teeth. Additional indications include: base/liner material, repair of enamel defects, repair of povisionals, repair of porcelain restorations, minor occlusal build-ups, pit and fissure sealant, luting of composite/ceramic veneers, core build-ups and incisal abrasions.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CER 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------ | ----------------------------------------------------------- |
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510(k) SUMMARY for SonicFill 2
Image /page/3/Picture/1 description: The image shows the logo for Sybron Dental Specialties. The logo features the letters 'sds' in a bold, sans-serif font, with a curved line above the letters. Below the letters, the words 'Sybron Dental Specialties' are written in a smaller, sans-serif font. The color of the text and curved line is a dark blue.
SonicFill 2
-
- Submitter Information: Sybron Dental Specialties 1717 W. Collins Ave. Orange CA, 92687
| Contact Person: | Kerri Casino |
|---|---|
| Telephone Number: | 714-516-7634 |
| Fax Number: | 714-516-7472 |
January 16, 2015 Date Prepared:
-
- Device Name:
- Proprietary Name: SonicFill 2 . ●
- Tooth Shade Resin Material Classification Name:
- 872.3690 CFR Number: ●
- Device Class: ● II
- . Product Code: EBF, EBC
-
- Predicate Device:
SonicFill 2 is substantially equivalent to the legally marketed device Metamorphosis (K091023) cleared on May 21, 2009, product code EBF, EBC.
-
- Description of Device:
SonicFill 2 is a light-cured, low-shrink, resin-based, dental restorative designed for direct placement. SonicFill 2 is used in combination with the SonicFill 2010 Handpiece (K091091), which activates the restorative sonically for delivery. Upon delivery the restorative drops in viscosity, allowing the composite to closely adapt to the cavity walls. When the cavity is filled and the SonicFill 2010 Handpiece (K091091) is deactivated, the restorative resin returns to its original viscosity. The composite in the cavity is then shaped and sculpted to the contours of the tooth. SonicFill 2 is designed to have a high depth of cure and low shrinkage stress allowing a cavity up to 5mm in depth to be filled and cured in a single bulk increment.
- Description of Device:
-
న. Statement of Intended Use:
SonicFill 2 is indicated for direct placement in all cavity classes in anterior and posterior teeth. Additional indications include: base/liner material, repair of enamel defects, repair of provisionals, repair of porcelain restorations, minor occlusal build-ups, pit and fissure sealant, luting of composite/ceramic veneers, core build-ups and incisal abrasions.
4
6. Identification of Risk Analysis Method
Risk analysis was performed on SonicFill 2 utilizing a process based on ISO 14971:2007. The results of the risk analysis performed on SonicFill 2 concluded that all device design controls and process controls will be able to mitigate known potential failures and effects. In addition, performance testing and biocompatibility testing were performed to mitigate other potential risks.
7. Description of Safety and Substantial Equivalence:
Technological Characteristics
The technological characteristics of SonicFill 2 are very similar to those of the predicate, Metamorphosis (K091023). Both composites are sonically activated using the SonicFill SonicFill 2010 Handpiece (K091091) during delivery. Both SonicFill 2 and Metamorphosis (K091023) composites behave in the same manner in terms of viscosity dropping during activation while adapting to the cavity, and viscosity increasing after activation ends. Both SonicFill 2 and Metamorphosis (K091023) use the same SonicFill 2010 Handpiece (K091091) and the same unidose delivery system.
Non-Clinical Performance Data
Non-clinical performance data included testing for mechanical strength, polishability, water sorption and solubility, flexural strength, depth of cure, light sensitivity, radiopacity, volumetric shrinkage, shrinkage stress, and color stability. Working Time testing, stability testing and biocompatibility testing were also performed. The data analyzed from the various tests substantiate that SonicFill 2 is as safe and effective as the predicate Metamorphosis (K091023). The following standards were utilized for the nonclinical performance testing of SonicFill 2:
- . Guidance for Industry and FDA Staff: Dental Composite Resin Devices -Premarket Notification [510(k)] Submissions, November 27, 1998
- ISO 10993-1: 2009 Biological evaluation of medical devices ●
- ISO 10993-3:2003 Biological Evaluation of Medical Devices- Part 3: Tests for . Genotoxicity, Carcinogenicity, and Reproductive Toxicity
- . ISO 10993-5:2009 Biological Evaluation of Medical Devices- Part 5: Tests for in Vitro Cytotoxicity
- . ISO 10993-6:2007 Biological Evaluation of Medical Devices- Part 6: Tests for Local Effects after Implantation
- . ISO 10993-10:2010 Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization
- ISO 14971:2007 Risk Management
- ISO 4049:2009 Dentistry- Polymer based Filling, Restorative, and Luting . Materials.
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| Element | Predicate Device-
Metamorphosis | SonicFill 2 |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | Metamorphosis (K091023) | To be assigned |
| Trade Name | SonicFill, Sonic-Activated Bulk Fill
Composite | SonicFill 2, Sonic-Activated Bulk
Fill Composite |
| Target Users | Licensed dental professionals | Licensed dental professionals |
| Device Description | Metamorphosis, a nano-hybrid
composite, is a light-cured, resin-
based, dental restorative designed for
direct placement. | SonicFill2, a nano-hybrid
composite, is a light cured, resin-
based dental restorative designed
for direct placement. |
| | Metamorphosis is packaged into tips,
which are custom-designed, single-
dose and made from plastic. The
single-dose tips are dispensed using
the SonicFill 2010 Handpiece
(K091091). | SonicFill 2 uses the same delivery
system as the predicate device
Metamorphosis, which are
custom-designed, single dose and
made from plastic. The single-
dose tips are dispensed using the
same SonicFill 2010 Handpiece
(K091091) as the predicate device. |
| Common Name | Dental Composite Restorative
Material | Dental Composite Restorative
Material |
| Classification Name | Tooth Shade Resin Material, per
CFR § 872.3690 and
Pit and Fissure Sealant and
Conditioner, per CFR § 872.3765 | Tooth Shade Resin Material, per
CFR § 872.3690 |
| Class | II | II |
| Product Code | EBF/ EBC | EBF/EBC |
| Storage | Ambient Temperature | Ambient Temperature |
| Curing Mechanism | Photo initiation | Photo initiation |
| Material
Compatibility | Biocompatibility meets requirements | Biocompatibility meets
requirements |
| Shelf Life | 24 months based on real time data | 24 months based on accelerated
data |
| UV Color Stability
per ISO 4049 | Pass | Pass |
| Volumetric Shrinkage | Pass | Equivalent to Predicate |
| Shrinkage Stress | Pass | Equivalent to Predicate |
| Depth of Cure | Pass | Pass |
| Light Sensitivity per
ISO 4049 | Pass | Pass |
| Flexural Strength per
ISO 4049 | Pass | Pass |
| Radiopacity per ISO
4049 | Pass | Pass |
| Translucency | Pass | Pass |
| Working Time | Pass | Pass |
| Water Sorption/
Solubility per ISO
4049 | Pass | Pass |
| Polishability | N/A | Pass |
Table 5.1: Predicate and Proposed Device Comparison Table
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Clinical Performance Data
Clinical performance testing has not been performed for SonicFill 2.
Conclusion as to Substantial Equivalence
SonicFill 2 has been tested for its strength, depth of cure, shrinkage, polishability, color It also has been verified as being substantially equivalent in stability, and safety. performance, safety, and effectiveness to the predicate Metamorphosis (K091023).