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.

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.

AI/ML Overview

The provided text describes the regulatory submission for the dental restorative material, SonicFill 2. It does not contain information about a study based on acceptance criteria for an AI/ML powered device, or a standard clinical trial with outcomes, or an MRMC study.

However, it does detail non-clinical performance testing for SonicFill 2, comparing it to a predicate device (Metamorphosis K091023). Based on this information, I can construct a table for the non-clinical performance and extract relevant details.

Here's the information extracted from the document, tailored to your request as much as possible given the content:

Device: SonicFill 2 (Dental Restorative Material)

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with numerical targets for each parameter. Instead, it compares SonicFill 2's performance to established standards (e.g., ISO 4049, ISO 10993 series) and to its predicate device, Metamorphosis (K091023), often indicating "Pass" or "Equivalent to Predicate."

Performance Characteristic	Acceptance Criteria (based on predicate/standards)	Reported Device Performance (SonicFill 2)
UV Color Stability (per ISO 4049)	Must Pass (as per predicate and standard)	Pass
Volumetric Shrinkage	Must Pass (as per predicate and standard)	Equivalent to Predicate
Shrinkage Stress	Must Pass (as per predicate and standard)	Equivalent to Predicate
Depth of Cure	Must Pass (as per predicate and standard)	Pass
Light Sensitivity (per ISO 4049)	Must Pass (as per predicate and standard)	Pass
Flexural Strength (per ISO 4049)	Must Pass (as per predicate and standard)	Pass
Radiopacity (per ISO 4049)	Must Pass (as per predicate and standard)	Pass
Translucency	Must Pass (as per predicate and standard)	Pass
Working Time	Must Pass (as per predicate and standard)	Pass
Water Sorption/Solubility (per ISO 4049)	Must Pass (as per predicate and standard)	Pass
Polishability	No comparable criterion for predicate (N/A)	Pass
Biocompatibility	Meets requirements (per predicate and ISO 10993 series)	Meets requirements
Shelf Life	24 months based on real-time data (for predicate)	24 months based on accelerated data

2. Sample size used for the test set and the data provenance

The document specifies "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." This indicates laboratory testing of the material itself.

Sample Size for Test Set: Not explicitly stated in terms of number of samples for each test. The tests are laboratory-based material characterization tests.
Data Provenance: The document does not specify a country of origin for the data or whether it's retrospective or prospective, as these terms are more typically applied to clinical studies. It describes internal laboratory testing data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The ground truth for material properties in this context is established by standardized testing methods (e.g., ISO standards), not by human expert consensus or interpretation.

4. Adjudication method for the test set

Not applicable. This is not a study involving human interpretation of data requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This document pertains to a dental restorative material, not an AI-powered diagnostic or assistive device that would involve human readers. The document explicitly states: "Clinical performance testing has not been performed for SonicFill 2."

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No, this is not an AI/ML algorithm. It is a dental material.

7. The type of ground truth used

The ground truth is based on standardized laboratory testing and measurements of material properties as defined by international standards (e.g., ISO 4049, ISO 10993 series). The comparison is also made against the performance of a legally marketed predicate device (Metamorphosis K091023).

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device that requires a training set.

Summary

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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.

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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)

K143209

Device Name SonicFill 2

Indications for Use (Describe)

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

1. 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:

1. Device Name:
- Proprietary Name: SonicFill 2 . ●
  - Tooth Shade Resin Material Classification Name:
- 872.3690 CFR Number: ●
- Device Class: ● II
- . Product Code: EBF, EBC
1. Predicate Device:

SonicFill 2 is substantially equivalent to the legally marketed device Metamorphosis (K091023) cleared on May 21, 2009, product code EBF, EBC.

1. 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.
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.

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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 FillComposite	SonicFill 2, Sonic-Activated BulkFill Composite
Target Users	Licensed dental professionals	Licensed dental professionals
Device Description	Metamorphosis, a nano-hybridcomposite, is a light-cured, resin-based, dental restorative designed fordirect placement.	SonicFill2, a nano-hybridcomposite, is a light cured, resin-based dental restorative designedfor direct placement.
	Metamorphosis is packaged into tips,which are custom-designed, single-dose and made from plastic. Thesingle-dose tips are dispensed usingthe SonicFill 2010 Handpiece(K091091).	SonicFill 2 uses the same deliverysystem as the predicate deviceMetamorphosis, which arecustom-designed, single dose andmade from plastic. The single-dose tips are dispensed using thesame SonicFill 2010 Handpiece(K091091) as the predicate device.
Common Name	Dental Composite RestorativeMaterial	Dental Composite RestorativeMaterial
Classification Name	Tooth Shade Resin Material, perCFR § 872.3690 andPit and Fissure Sealant andConditioner, per CFR § 872.3765	Tooth Shade Resin Material, perCFR § 872.3690
Class	II	II
Product Code	EBF/ EBC	EBF/EBC
Storage	Ambient Temperature	Ambient Temperature
Curing Mechanism	Photo initiation	Photo initiation
MaterialCompatibility	Biocompatibility meets requirements	Biocompatibility meetsrequirements
Shelf Life	24 months based on real time data	24 months based on accelerateddata
UV Color Stabilityper ISO 4049	Pass	Pass
Volumetric Shrinkage	Pass	Equivalent to Predicate
Shrinkage Stress	Pass	Equivalent to Predicate
Depth of Cure	Pass	Pass
Light Sensitivity perISO 4049	Pass	Pass
Flexural Strength perISO 4049	Pass	Pass
Radiopacity per ISO4049	Pass	Pass
Translucency	Pass	Pass
Working Time	Pass	Pass
Water Sorption/Solubility per ISO4049	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).

Regulation Number and Section

§ 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.