(115 days)
Not Found
No
The summary describes a resin-based composite material and its physical properties, with no mention of AI or ML capabilities.
No.
The device is a resin-based composite material used for lining or preventive resin restorations in teeth, which are structural and restorative functions, not therapeutic.
No
The device is a restorative material used in dental procedures, not for diagnosing conditions. Its primary function is to serve as a liner or restorative material, not to identify or characterize diseases or health conditions.
No
The device description clearly states it is a "resin-based, flowable polymerizable composite paste," indicating it is a physical material, not software. The performance studies also focus on material properties like radiopacity, compressive strength, and depth of cure.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for use as a liner or initial layer beneath composite resins, or as a flowable composite in preventive resin restorations. This is a direct application within the patient's mouth for restorative dental procedures.
- Device Description: The description confirms it's a resin-based, flowable composite paste used as a lining material or for preventive resin restorations. This is a material applied to the tooth.
- Lack of In Vitro Testing: The description of performance studies focuses on physical and mechanical properties of the material itself (light curing, radiopacity, compressive strength, depth of cure, biocompatibility). There is no mention of testing patient samples (blood, urine, tissue, etc.) to provide diagnostic information.
- Anatomical Site: The anatomical site is the tooth, which is a part of the patient's body. IVDs typically analyze samples taken from the body.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, disease or congenital abnormality. This device does not fit that definition.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
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 radiographic observation compared to enamel, dentin, and possible secondary caries.
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
Licensed Dentist
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)
Comparison of technological characteristics between Calcium Bridge and predicate device Tetric EvoCeram, including light curing capability (cures less than 20 seconds for both), radiopacity (3.5 mm Aluminum for Calcium Bridge, 2.0 mm Aluminum for predicate), fluorescence (visible blue glow detected for both), compressive strength (Greater Than 250 MPa for Calcium Bridge, 250 MPa for predicate), depth of cure (Greater Than 1.5 mm for both), and biocompatibility (Zone of Inhibition 0.25 cm for Calcium Bridge, N/A for predicate). Differences in radiopacity and compressive strength were noted but determined not to change performance or usage. Biocompatibility was assessed according to ISO 10993-5.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Light Curing Capability: Cures Less Than 20 seconds
Radiopaque, Aluminum Equivalent to Equal 1 mm: 3.5 mm Aluminum (Calcium Bridge), 2.0 mm Aluminum (Tetric Evoceram)
Fluorescence, Visible Blue Glow Under UV Lighting: Visible Blue Glow Detected
Compressive Strength (MPa): Greater Than 250 MPa (Calcium Bridge), 250 MPa (Tetric Evoceram)
Depth of Cure Greater Than 1.5 mm: Greater Than 1.5 mm
Biocompatibility, ISO 10993-5 (Cytoxicity): Zone of Inhibition 0.25 cm (Calcium Bridge)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Tetric EvoCeram (K042819)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other. The profiles are simple and abstract, with a flowing, wave-like design.
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.
1
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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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)
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 CORPORATION |
| 134 Old Washington Street / Hanover, MA 02339-1629 | |
| OWNER/CONTACT PERSON | Dr. Jan G. Stannard |
| TEL: 781-826-9190 / FAX: 781-826-4465 | |
| j.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 equivalent |
| under the 510(k) premarket notification process as Class II Dental | |
| Devices under CFR EBF 872.3690, Tooth Shade Resin Material. | |
| DEVICE DESCRIPTION | Calcium Bridge is a resin-based, flowable polymerizable composite paste recom |
| mended 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. | |
| 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. | |
| TECHNOLOGICAL | |
| CHARACTERISTICS | |
| SUMMARY | Calcium Bridge has the same technological characteristics as the predicate device |
| Tetric 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 compressive | |
| 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
"Evaluation of Medical Devices-Cytotoxicity", and is consistent in formulation
to Tetric EvoCeram, in its intended use and biocompatibility. |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBSTANTIAL
EQUIVALENCE
DETERMINATION AND
SUMMARY | 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 comparison
of the physical and mechanical characteristics (tensile strength, compressive
strength), 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 subject
device reflect the current usage of the term "flowable composite". A flowable
composite is used today for the predicate device's Indications For Use. The usage of
the term flowable composite does not effect any usage or performance difference
between the subject and predicate device. Calcium Bridge has been found to be
substantially equivalent in design, composition, ageing, biocompatibility,
performance, and intended use to Tetric EvoCeram. |