Calcium Bridge

K153191 · Denali Corporation · EBF · Feb 26, 2016 · Dental

Device Facts

• Record ID: K153191
• Device Name: Calcium Bridge
• Applicant: Denali Corporation
• Product Code: EBF · Dental
• Decision Date: Feb 26, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Calcium Bridge is a resin-based composite recommended for use as a liner or initial layer beneath all composite resins or as flowable composite in preventive resin restorations. For Use only by a Licensed Dentist. Rx Use Only.

Device Story

Calcium Bridge is a resin-based, flowable, polymerizable composite paste used by licensed dentists in clinical settings. It serves as a cavity liner or initial layer beneath composite resins, or as a material for preventive resin restorations (PRR) to treat caries. The device is light-cured (curing in less than 20 seconds). Its high radiopacity allows for radiographic observation of the restoration relative to enamel, dentin, and secondary caries. The clinician applies the material to the tooth structure; the material hardens upon light exposure. The device provides a protective layer and aids in the treatment of dental caries, benefiting the patient through restorative support and improved diagnostic visibility via radiopacity.

Clinical Evidence

Bench testing only. Comparison of physical and mechanical properties between Calcium Bridge and Tetric EvoCeram, including compressive strength, depth of cure, setting time, radiopacity, and fluorescence. Biocompatibility testing performed per ISO 10993-5 (Cytotoxicity).

Technological Characteristics

Resin-based composite; light-cured (curing <20 seconds); radiopaque (3.5 mm Aluminum equivalent); compressive strength >250 MPa; depth of cure >1.5 mm; exhibits fluorescence under UV light. Biocompatible per ISO 10993-5.

Indications for Use

Indicated for use as a liner or initial layer beneath composite resins or as a flowable composite in preventive resin restorations by licensed dentists.

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

• Tetric EvoCeram (k042819)

Submission Summary (Full Text)

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

February 26, 2016

Denali Corporation Ms. Jan G. Stannard President 134 Old Washington Street Hanover, Massachusetts 02339

Re: K153191

Trade/Device Name: Calcium Bridge Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade resin material Regulatory Class: II Product Code: EBF Dated: January 15, 2016 Received: January 19, 2016

Dear Ms. Stannard:

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 Industry and Consumer Education at its toll-free number [phone] or [phone] 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 Industry and Consumer Education at its toll-free number [phone] or [phone] 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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Image /page/2/Picture/1 description: The image shows the logo for Denali Corporation. The logo consists of a blue triangle with a blue sphere and a white arc around it on the left, and the words "denali corporation" in gray on the right. The text is in a bold, sans-serif font.

#### INDICATIONS FOR USE STATEMENT

510 (k) Number K153191 (if known)

Device Name

### Calcium Bridge

#### Indications for Use:

Calcium Bridge is a resin-based composite recommended for use as a liner or initial layer beneath all composite resins or as flowable composite in preventive resin restorations. For Use only by a Licensed Dentist. Rx Use Only.

Please do not write below this line. Continue on another page if needed.

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Prescription Use (Per 21 CFR 801.109)

or

Over-The-Counter Use

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# 510 (k) Summary

Image /page/3/Picture/1 description: The image shows the logo for Denali Corporation. The logo includes a blue and black geometric shape with a blue sphere and a curved line around it. The text "denali corporation" is written in gray next to the logo. Below the company name is the address "134 Old Washington Street, Hanover, MA 02339 USA" also written in gray.

T 781.826.9190 F 781.826.4465 denalicorporation.com

| February 26, 2016 | denalicorporation.com |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ADDRESS | DENALI CORPORATION<br>134 Old Washington Street / Hanover, MA 02339-1629 |
| OWNER/CONTACT PERSON | Dr. Jan G. Stannard |
| | TEL: [phone] / FAX: [phone]<br>[e-mail] |
| TRADE NAME | Calcium Bridge |
| COMMON NAME | Cavity Liner, Flowable Composite |
| CLASSIFICATION NAME | Tooth Shade Resin Material, Class II (21 CFR 872.3690, Product Code EBF) |
| REGISTRATION | 3006367836 |
| PREDICATE DEVICES | Tetric EvoCeram (k042819) |
| EQUIVALENCE | The predicate product has been found to be substantially equivalent<br>under the 510(k) premarket notification process as Class II Dental<br>Devices under CFR EBF 872.3690, Tooth Shade Resin Material. |
| DEVICE DESCRIPTION | Calcium Bridge is a resin-based, flowable polymerizable composite paste recom<br>mended as a lining material beneath composite resins or as a preventive resin<br>restoration (PRR) material (a minimally invasive procedure to protect a tooth). A PRR<br>restoration is not intended to prevent caries but intended to be used in the treatment of<br>caries. Because Calcium Bridge is highly radio-opaque this allows for easy radio-<br>graphic observation compared to enamel, dentin, and possible secondary caries. |
| INDICATIONS FOR USE | Calcium Bridge is a resin-based composite recommended for use as a liner or initial<br>layer beneath all composite resins, or as flowable composite in preventive resin<br>restorations.<br><b>For Use only by a Licensed Dentist. Rx Use Only.</b> |
| TECHNOLOGICAL<br>CHARACTERISTICS<br>SUMMARY | Calcium Bridge has the same technological characteristics as the predicate device<br>Tetric Evoceram including: design, composition, biocompatibility, performance,<br>ageing, intended use, physical characteristics, setting time, depth of cure, radio-<br>opacity fluorecensing ability and mechanical properties (tensile and compressive<br>strength), as summarized in the Table below. |

| Summary of Characteristics of Calcium Bridge and the Predicate Product | | | |
|------------------------------------------------------------------------|----------------------------|----------------------------|--|
| Property | Calcium Bridge | Tetric Evoceram | |
| Light Curing Capability, Cures Less Than 20 seconds | Cures Less Than 20 seconds | Cures Less Than 20 seconds | |
| Radiopaque, Aluminum Equivalent to Equal 1 mm | 3.5 mm Aluminum | 2.0 mm Aluminum | |
| Fluorescence, Visible Blue Glow Under UV Lighting | Visible Blue Glow Detected | Visible Blue Glow Detected | |
| Compressive Strength (MPa) | Greater Than 250 MPa | 250 MPa | |
| Depth of Cure Greater Than 1.5 mm | Greater Than 1.5 mm | Greater Than 1.5 mm | |
| Biocompatiblity, ISO 10993-5 (Cytoxicity) | Zone of Inhibition 0.25 cm | N/A - Not Available | |

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## 510 (k) Summary

Image /page/4/Picture/1 description: The image shows the logo for Denali Corporation. The logo includes a stylized graphic of a blue sphere orbiting a geometric shape. The text "denali corporation" is next to the graphic, and below that is the address "134 Old Washington Street, Hanover, MA 02339 USA".

T 781.826.9190 F 781.826.4465 denalicorporation.com

The differences between Calcium Bridge and the predicate product in the above Table are that of radiopacity and compressive strength. In this case, Calcium Bridge is more radiopague than the predicate device. Calcium Bridge was also found to have a higher compressive strength than the predicate product. These differences do not change the performance or usage between the subject and the predicate device.

| BIOCOMPATIBILITY | Calcium Bridge was found to be biocompatible according to ISO 10993-5<br>"Evaluation of Medical Devices-Cytotoxicity", and is consistent in formulation<br>to Tetric EvoCeram, in its intended use and biocompatibility. |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBSTANTIAL<br>EQUIVALENCE<br>DETERMINATION AND<br>SUMMARY | Calcium Bridge is substantially equivalent in design, composition, biocompatibility<br>(ISO 10993-5, Evaluation of Medical Devices - Cytotoxicty), performance, ageing,<br>and intended use to Tetric EvoCeram. This assessment is based upon a comparison<br>of the physical and mechanical characteristics (tensile strength, compressive<br>strength), depth of cure, setting time, radio-opacity, and fluorecesing ability.<br>The results of these tests are equivalent to the values of Tetric EvoCeram. |
| CONCLUSIONS | Differences in the Indications For Use between the predicate device and the subject<br>device reflect the current usage of the term "flowable composite". A flowable<br>composite is used today for the predicate device's Indications For Use. The usage of<br>the term flowable composite does not effect any usage or performance difference<br>between the subject and predicate device. Calcium Bridge has been found to be<br>substantially equivalent in design, composition, ageing, biocompatibility,<br>performance, and intended use to Tetric EvoCeram. |