Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use clearly describe a dental composite material, not a software or hardware device that would typically incorporate AI/ML. There are no mentions of AI, ML, image processing, or data sets for training/testing.

Therapeutic

No.
The device is a composite material used for dental fillings and cavity lining, which is a restorative material rather than a device for treating or curing a disease or condition.

Diagnostic

No
Explanation: The device is a dental restorative material (composite) used for filling cavities. It does not perform any diagnostic function. Its purpose is to repair tooth structure, not to detect or assess a condition.

SaMD (Software as a Medical Device)

No

The device is a physical dental composite material, not a software application.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for filling and lining cavities in teeth. This is a direct treatment applied to the patient's tooth structure.
Device Description: The device is a composite material used for dental restorations. It is applied directly to the tooth.
Anatomical Site: The anatomical site is tooth structure.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.

IVDs are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (within the body) as a restorative material.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

UFill Bulk Fill Posterior Flowable Composite is indicated for use (i) in fillings with layer thicknesses up to 4mm in Class I and II cavities, (ii) in cavity lining- as a first (bottom layer) in Class I and II cavities.

Product codes

EBF

Device Description

UFill Bulk Fill Posterior Flowable Composite is à light cure radiopaque posterior composite for use in the Bulk-Fill Technique. The flowable viscous material is suitable for filling layers of up to 4mm in thickness and as a cavity lining (bottom layer) for both Class I and II restorations. Placed in a unit dose needle capsule containing 0.25g of material, the device is delivered by a standard dental unit-dose tip applicator dispenser gun, and offered in a universal dentin shade that is formulated and manufactured without Bis-GMA, HEMA, or TEG-DMA.

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)

Physical testing per ISO 4049-2009, Dentistry -- Polymer-based restorative materials was conducted with all criteria for success satisfied.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K120453

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

510(k) SUMMARY

JUL 0 2 2014

K140512 Premarket Notification Number ________________________________________________________________________________________________________________________________________________

This 510(k) summary information is being submitted in accordance with the requirements of 21 CFR 807.92.

510(k) Sponsor:

Juno Dentistry LP 63 Wall Street, Madison, CT. 06443

Submitted by:

Roger Mastrony MedTek LLC 848-1/2 Derby Avenue Orange, CT. 06477

Date of Submission: February 21, 2014

Device Classification:

Class 2 Ref §21CFR 872.3690

Product Code:

EBF

Trade Name:

UFill Bulk Fill Posterior Flowable Composite

Common Name:

Tooth shade resin material

1

Device Description:

UFill Bulk Fill Posterior Flowable Composite is à light cure radiopaque posterior composite for use in the Bulk-Fill Technique. The flowable viscous material is suitable for filling layers of up to 4mm in thickness and as a cavity lining (bottom layer) for both Class I and II restorations. Placed in a unit dose needle capsule containing 0.25g of material, the device is delivered by a standard dental unit-dose tip applicator dispenser gun, and offered in a universal dentin shade that is formulated and manufactured without Bis-GMA, HEMA, or TEG-DMA.

Predicate Device(s):

3m-Filtek Bulk Fill Flowable Restorative cleared under K120453

Indications for Use:

UFill Bulk Fill Posterior Flowable Composite is indicated for use (i) in fillings with layer thicknesses up to 4mm in Class I and II cavities, (ii) in cavity lining- as a first (bottom layer) in Class I and II cavities.

Technological Characteristics:

UFill Bulk Fill Posterior Flowable Composite is a one-part light-curing, radiopaque posterior composite for use in a bulk-fill technique. The composite contains UDMA and BDDMA as resin components. A combination of silanized strontium aluminum boron silicate glass and silanized silica with a range of particle size from 0.04 to 15 um is used as fillers. The inorqanic filler loading is approximately 77 % by weight.

A dental adhesive is used to permanently bond the restoration to the tooth structure. When irradiated by light, the methacrylate functionalities of the resin and fillers undergo, in conjunction with the photoinitiator system, a light induced polymerization to form a hard composite that is bonded to the tooth structure with a permanent dental adhesive.

Performance Testing:

Physical testing per ISO 4049-2009, Dentistry -- Polymer-based restorative materials was conducted with all criteria for success satisfied.

2

Safety Testing:

The device has undergone evaluation and testing in accordance with AAMI/ANSI/ISO 10993-1:2009, Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process. The device was found to be suitable for body contact type and duration.

Risk Management:

The device has been evaluated in accordance with ISO 14971:2007 Medical devices - Application of risk management to medical devices. The device is safe and effective as no new risks have been identified.

Substantial Equivalence Discussion:

Substantial equivalence of the subject device, UFill Bulk Fill Posterior Composite is claimed to the predicate device, 3M - Filtek Bulk Fill cleared under K120453. The following discussion provides evidence to substantiate that claim.

Specifically,

Indications .
Intended Use .
Basic composition of materials .
Light activated cure .
Delivery System /Method of application .
Shade
Depth of cure
Performance characteristics

3

:

.

4

	SUBJECT DEVICE	PREDICATE DEVICE
	UFill Bulk Fill Posterior
Composite	3M - Filtek Bulk Fill
(K120453)
Intended Use	Fillings with Class I and II cavities,

In cavity lining- as a first
(bottom layer) in Class I
and II cavities. | Base under Class I and II direct restorations.

Liner under direct restorative
materials |
| Basic material
composition | UDMA and BDDMA as
resin components

Silicate glass and
silanized silica fillers | UDMA and BDDMA as resin
components

Flowable

Compliant to ISO 4049
Fourth edition 2009-10-
01 Dentistry - Polymer-
based restorative material
(see Performance Testing-
Bench) | Radiopaque

Flowable

Compliant to ISO 4049
Fourth edition 2009-10-01
Dentistry - Polymer-based
restorative material |

Conclusion:

There are no differences in the technological characteristics or indications for use between the subject and predicate device that raise different questions of safety & effectiveness. The subject device indications are a sub set of and are identical to those indications in the predicate device.

5

Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings. The bird is positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the bird.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

1

July 2, 2014

Juno Dentistry LP C/O Mr. Roger Mastrony MedTek LLC 848-1/2 Derby Avenue Orange, CT 06477

Re: K140512

Trade/Device Name: UFill Bulk Fill Posterior Flowable Composite Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: May 29, 2014 Received: June 3, 2014

Dear Mr. Mastrony:

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.

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

6

Page 2 - Mr. Mastrony

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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Manf. By Bunner -S

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

7

Addendum B

Indications for Use Statement

(Prescribed format)

Follows this page

8

(Page 1 of 1)

Indications for Use

510(k) Number (if

known): _________ K140512

Device Name: UFill Bulk Fill Posterior Flowable Composite Indications for Use:

. UFill Bulk Fill Posterior Flowable Composite is indicated for use (i) in fillings with layer thicknesses up to 4mm in Class I and II cavities, (ii) in cavity lining- as a first (bottom layer) in Class I and II cavities

AND/OR Over-The-Counter Use Prescription Use X (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sheena A 2014.07.02 -04'00'