Ecosite Bulk Fill

K171772 · Dmg USA, Inc. · EBF · Jan 31, 2018 · Dental

Device Facts

• Record ID: K171772
• Device Name: Ecosite Bulk Fill
• Applicant: Dmg USA, Inc.
• Product Code: EBF · Dental
• Decision Date: Jan 31, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Restorations in the posterior region (Classes I and II, including replacement of individual cusps) Restorations of class V (cervical caries, root erosions, wedge-shaped defects) Core build-up Restorations in deciduous teeth

Device Story

Ecosite Bulk Fill is a light-curing, radiopaque restorative material for dental use. It is applied by dental professionals in a clinical setting to restore tooth structure. The material is placed into the cavity preparation and cured using a dental light-curing unit. It functions as a restorative resin to replace lost tooth structure in posterior teeth, Class V defects, and deciduous teeth, or to provide core build-up. The output is a hardened, tooth-colored restoration that restores form and function to the patient's tooth, potentially preventing further decay or structural failure.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing comparing physical and mechanical properties (compressive strength, flexural strength, depth of cure, surface hardness, radio-opacity, water sorption/solubility, and fluoride release) and biocompatibility testing per ISO 7405 (2008) and FDA guidance.

Technological Characteristics

Light-curing, radiopaque dental restorative material. Composition: Barium glass filler (82% wt/65% vol) in a Bis-GMA-based resin matrix. Filler particle size: 0.02–0.7 µm. Physical properties: 420 MPa compressive strength, 138 MPa flexural strength, 5.3 mm depth of cure. Biocompatibility evaluated per ISO 7405.

Indications for Use

Indicated for dental restorations in the posterior region (Classes I and II, including cusp replacement), Class V restorations (cervical caries, root erosions, wedge-shaped defects), core build-ups, and restorations in deciduous teeth.

Regulatory Classification

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.

Predicate Devices

• Nanocomposite Restorative Kit (K080480)

Reference Devices

• LuxaCore/LuxaCore Dual (K012307)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

DMG USA Inc. % Pam Papineau Consultant President Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer, Massachusetts 01432

January 31, 2018

Re: K171772

Trade/Device Name: Ecosite Bulk Fill Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: December 20, 2017 Received: January 17, 2018

## Dear Pam Papineau:

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

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device 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.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K171772

Device Name Ecosite Bulk Fill

Indications for Use (Describe)

- · Restorations in the posterior region (Classes I and II, including replacement of individual cusps)
- · Restorations of class V (cervical caries, root erosions, wedge-shaped defects)
- · Core build-up
- Restorations in deciduous teeth

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

{3}------------------------------------------------

# Section 5 – 510(k) Summary

## K171772

1. Submitter Information DMG USA, Inc. 23 Frank Mossberg Drive Attleboro, MA 02703, USA Phone: [phone] Fax: [phone]

Contact Person: Pamela Papineau, RAC (US, EU, CAN) Phone: [phone] Fax: [phone] E: [e-mail]

Date prepared: 30 January 2018

2. Device Name Name of device: Ecosite Bulk Fill Common name: Tooth shade resin material Classification name: Material, Tooth Shade, Resin (21 CFR 872.3690) Requlatory device class: II Product code: EBF

3. Predicate Device and Reference Devices Nanocomposite Restorative Kit (K080480); Primary Predicate Device LuxaCore/LuxaCore Dual (K012307); Reference Device

4. Device Description

Ecosite Bulk Fill is a light-curing, radiopaque restorative material developed especially for use in the posterior region.

5. Indications for Use

- Restorations in the posterior region (Classes I and II, including replacement of individual cusps)
- · Restorations of class V (cervical caries, root erosions, wedge-shaped defects)
- Core build-up
- Restorations in deciduous teeth

### 6. Comparison to the Predicate Device

A comparison of Ecosite Bulk Fill with the predicate device indicates the following similarities and differences.

{4}------------------------------------------------

| Definition or | Product | | |
|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Property [unit] | Ecosite Bulk Fill<br>(proposed device) | Nanocomposite<br>(predicate device)<br>(K080480) | |
| Common name | Restorative material | Restorative material | |
| Classification name | Tooth shade resin material<br>21 CFR 872.3690 | Tooth shade resin material<br>21 CFR 872.3690 | |
| Product code | EBF | EBF | |
| Indications for Use | Restorations in the posterior<br>region (Classes I and II,<br>including replacement of<br>individual cusps)<br>Restorations of Class V<br>(cervical caries, root erosions,<br>wedge-shaped defects)<br>Core build-up<br>Restorations in deciduous teeth | Restorations of all cavity<br>classes<br>Fabrication of direct inlays,<br>onlays and indirect veneers<br>Core build-up after tooth<br>preparation with the root canal<br>post<br>Machinable Composite for<br>Restorations<br>Indirect Inlays/Onlays | |
| Composition | Barium glass in a Bis-GMA-<br>based matrix of dental resins.<br>Pigments, additives and<br>catalyst. Filler content: 82% by<br>weight = 65% by volume. The<br>range of variation of the<br>inorqanic filler particles is<br>between 0.02 and 0.7 µm<br>(d50/d50) . | Barium glass in a Bis-GMA-<br>based matrix of dental resins.<br>Pigments, additives and<br>catalyst. Filler ratio: 82 percent<br>by weight = 65 percent by<br>volume (0.02 - 1.5 µm<br>expressed as d50/d90 or 0.02 -<br>0.7 µm expressed as d50/d50). | |
| Curing mechanism | Light-curing | Light-curing | |
| Compressive strength | 420 MPa | 475 MPa | |
| Flexural strength | 138 MPa | 134 MPa | |
| Elastic modulus | 10.7 GPa | (not specified) | |
| Depth of cure | 5.3 mm | 6.3 mm | |
| Surface hardness | 80 | 84 | |
| Radio-opacity | 230 % Al | 241 % Al | |
| Water sorption | 15.9 µg/mm3 | 17.4 µg/mm3 | |
| Water solubility | -0.1 µg/mm3 | 1.7 µg/mm³ | |
| Fluoride release,<br>measured as<br>cumulative value over 7<br>days | 13.1 ppm | 16.1 ppm | |

Ecosite Bulk fill is similar to the predicate device Nanocomposite in that they are both light-curing tooth shade resin materials to be used for dental restorations. The devices have substantially equivalent physical and mechanical properties as well as a substantially equivalent composition.

The subject and predicate devices have slightly different Indications for Use wording. Ecosite Bulk Fill is different from the predicate device in that different shades of the

{5}------------------------------------------------

material are available and the shades are suitable for restorations in the posterior region. The differences in the Indications for Use affect neither the Intended Use nor substantial equivalence.

The predicate device, Nanocomposite, has the same FDA Product Code (EBF = Tooth shade resin material) as the proposed device Ecosite Bulk Fill. The composition of Nanocomposite is substantially equivalent to Ecosite Bulk Fill. Thus Ecosite Bulk Fill is similar to the predicate Nanocomposite in composition, curing and indications.

## 7. Non-Clinical Performance Data

Physical and mechanical properties of Ecosite Bulk Fill were investigated and compared to the predicate device in accordance with the FDA Guidance for Industry and FDA Staff: "Dental Composite Resin Devices – Premarket Notification [510(k)] Submissions", issued on 26 October 2005 (compressive strength, flexural strength, particle size range, depth of cure, surface hardness, radio-opacity, water sorption and solubility, fluoride release, biocompatibility). Comparative data relevant for dental restoration materials demonstrate substantial equivalence of Ecosite Bulk Fill to the predicate device, Nanocomposite.

The biocompatibility testing was performed according to the FDA 1998 Guidance and the following consensus standard:

- ISO Standard 7405 Second edition (2008): Dentistry Evaluation of . biocompatibility of medical devices used in dentistry
Biocompatibility was demonstrated using the primary predicate (K080480) and reference device (K012307) per use of the FDA Guidance Document Dental Composite Resin Devices – Premarket Notification [510(k)] Submissions.

Substantial equivalence to the predicate device and reference device was demonstrated by comparison of the composition, including colorants.

## 8. Clinical Performance Data

Not applicable. Clinical performance testing has not been performed for the proposed device.

## 9. Conclusions

Based on the device Indications for Use, composition, and physical / mechanical properties, Ecosite Bulk Fill has been shown to be substantially equivalent to the predicate device.