(231 days)
No
The 510(k) summary describes a dental restorative material and its physical/mechanical properties, with no mention of AI or ML technology.
No.
The device is a restorative material for dental use, specifically a light-curing, radiopaque composite for various types of restorations in teeth. It is used to fill cavities and rebuild tooth structure, which is a restorative function, not a therapeutic one.
No
Ecosite Bulk Fill is described as a "light-curing, radiopaque restorative material" for dental restorations and core build-ups. Its intended use is to repair or replace existing dental structures, not to identify or diagnose conditions.
No
The device description explicitly states it is a "light-curing, radiopaque restorative material," which is a physical substance, not software. The performance studies also focus on physical and mechanical properties of the material.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a restorative material for dental procedures (filling cavities, building up cores, etc.). This is a therapeutic use, not a diagnostic one.
- Device Description: The description confirms it's a "light-curing, radiopaque restorative material." This aligns with a material used to repair or replace damaged tooth structure.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or condition.
- Performance Studies: The performance studies focus on the physical and mechanical properties of the material (strength, hardness, depth of cure, etc.) and its biocompatibility, which are relevant for a restorative dental material. They do not involve evaluating its ability to detect or measure a biological marker or condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / 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
Product codes
EBF
Device Description
Ecosite Bulk Fill is a light-curing, radiopaque restorative material developed especially for use in the posterior region.
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
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.
Clinical Performance Data: Not applicable. Clinical performance testing has not been performed for the proposed device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
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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)
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Section 5 – 510(k) Summary
K171772
- Submitter Information DMG USA, Inc. 23 Frank Mossberg Drive Attleboro, MA 02703, USA Phone: (508) 226-5660 Fax: (508) 226-7528
Contact Person: Pamela Papineau, RAC (US, EU, CAN) Phone: (978) 391-1391 Fax: (978) 391-1392 E: delphimdc@comcast.net
Date prepared: 30 January 2018
-
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
-
Predicate Device and Reference Devices Nanocomposite Restorative Kit (K080480); Primary Predicate Device LuxaCore/LuxaCore Dual (K012307); Reference Device
-
Device Description
Ecosite Bulk Fill is a light-curing, radiopaque restorative material developed especially for use in the posterior region.
- 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.
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| Definition or | Product | ||
|---|---|---|---|
| Property [unit] | Ecosite Bulk Fill | ||
| (proposed device) | Nanocomposite | ||
| (predicate device) | |||
| (K080480) | |||
| Common name | Restorative material | Restorative material | |
| Classification name | Tooth shade resin material | ||
| 21 CFR 872.3690 | Tooth shade resin material | ||
| 21 CFR 872.3690 | |||
| Product code | EBF | EBF | |
| 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 | Restorations of all cavity | ||
| classes | |||
| Fabrication of direct inlays, | |||
| onlays and indirect veneers | |||
| Core build-up after tooth | |||
| preparation with the root canal | |||
| post | |||
| Machinable Composite for | |||
| Restorations | |||
| Indirect Inlays/Onlays | |||
| Composition | Barium glass in a Bis-GMA- | ||
| based matrix of dental resins. | |||
| Pigments, additives and | |||
| catalyst. Filler content: 82% by | |||
| weight = 65% by volume. The | |||
| range of variation of the | |||
| inorqanic filler particles is | |||
| between 0.02 and 0.7 µm | |||
| (d50/d50) . | Barium glass in a Bis-GMA- | ||
| based matrix of dental resins. | |||
| Pigments, additives and | |||
| catalyst. Filler ratio: 82 percent | |||
| by weight = 65 percent by | |||
| volume (0.02 - 1.5 µm | |||
| expressed as d50/d90 or 0.02 - | |||
| 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, | |||
| measured as | |||
| cumulative value over 7 | |||
| 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.