(115 days)
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.
Calcium Bridge is a resin-based, flowable polymerizable composite paste recommended as a lining material beneath composite resins or as a preventive resin restoration (PRR) material (a minimally invasive procedure to protect a tooth). A PRR restoration is not intended to prevent caries but intended to be used in the treatment of caries. Because Calcium Bridge is highly radio-opaque this allows for easy radio-graphic observation compared to enamel, dentin, and possible secondary caries.
This document is a 510(k) summary for a dental device called "Calcium Bridge." It compares the device to a predicate device, "Tetric EvoCeram," to demonstrate substantial equivalence. It does not contain information about a study proving the device meets acceptance criteria related to AI or digital image analysis. Therefore, it's not possible to provide the requested information.
The document discusses the following properties, which could be considered acceptance criteria for a dental material:
Table of Acceptance Criteria and Reported Device Performance (as inferred from the provided test values):
| Property | Acceptance Criteria (Predicate) | Reported Device Performance (Calcium Bridge) |
|---|---|---|
| Light Curing Capability | Cures Less Than 20 seconds | Cures Less Than 20 seconds |
| Radiopacity (Aluminum Equivalent) | Equal to 2.0 mm Aluminum | 3.5 mm Aluminum |
| Fluorescence | Visible Blue Glow Detected | Visible Blue Glow Detected |
| Compressive Strength | 250 MPa | Greater Than 250 MPa |
| Depth of Cure | Greater Than 1.5 mm | Greater Than 1.5 mm |
| Biocompatibility (ISO 10993-5, Cytotoxicity) | (N/A - Not Available for Predicate) | Zone of Inhibition 0.25 cm |
Missing Information (based on your request, but not present in the document):
The document does not describe a study involving human readers, AI, or ground truth establishment in the context of diagnostic performance. Therefore, I cannot answer the following parts of your request:
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
- Standalone (algorithm only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How the ground truth for the training set was established.
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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 (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 Industry and Consumer Education 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 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)
风
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 CORPORATION134 Old Washington Street / Hanover, MA 02339-1629 |
| OWNER/CONTACT PERSON | Dr. Jan G. Stannard |
| TEL: 781-826-9190 / FAX: 781-826-4465j.stannard@denalicorporation.com | |
| 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 equivalentunder the 510(k) premarket notification process as Class II DentalDevices under CFR EBF 872.3690, Tooth Shade Resin Material. |
| DEVICE DESCRIPTION | Calcium Bridge is a resin-based, flowable polymerizable composite paste recommended as a lining material beneath composite resins or as a preventive resinrestoration (PRR) material (a minimally invasive procedure to protect a tooth). A PRRrestoration is not intended to prevent caries but intended to be used in the treatment ofcaries. Because Calcium Bridge is highly radio-opaque this allows for easy radio-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 initiallayer beneath all composite resins, or as flowable composite in preventive resinrestorations.For Use only by a Licensed Dentist. Rx Use Only. |
| TECHNOLOGICALCHARACTERISTICSSUMMARY | Calcium Bridge has the same technological characteristics as the predicate deviceTetric Evoceram including: design, composition, biocompatibility, performance,ageing, intended use, physical characteristics, setting time, depth of cure, radio-opacity fluorecensing ability and mechanical properties (tensile and compressivestrength), 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
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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"Evaluation of Medical Devices-Cytotoxicity", and is consistent in formulationto Tetric EvoCeram, in its intended use and biocompatibility. |
|---|---|
| SUBSTANTIALEQUIVALENCEDETERMINATION ANDSUMMARY | Calcium Bridge is substantially equivalent in design, composition, biocompatibility(ISO 10993-5, Evaluation of Medical Devices - Cytotoxicty), performance, ageing,and intended use to Tetric EvoCeram. This assessment is based upon a comparisonof the physical and mechanical characteristics (tensile strength, compressivestrength), depth of cure, setting time, radio-opacity, and fluorecesing ability.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 subjectdevice reflect the current usage of the term "flowable composite". A flowablecomposite is used today for the predicate device's Indications For Use. The usage ofthe term flowable composite does not effect any usage or performance differencebetween the subject and predicate device. Calcium Bridge has been found to besubstantially equivalent in design, composition, ageing, biocompatibility,performance, and intended use to Tetric EvoCeram. |
§ 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.