(56 days)
Not Found
No
The summary describes a material (resin-modified calcium silicate) used for dental procedures and its physical/mechanical properties. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is used to treat damaged dentin and is indicated for uses such as pulpotomy, repair of root and furcation perforations, and pulp exposures, all of which are therapeutic interventions.
No
The device, TheraCal DC, is a resin-modified calcium silicate used for treating damaged dentin and for various dental repair procedures. Its intended uses (pulpotomy, temporary filling, root/furcation perforation repair, etc.) and the description of its properties and testing (flexural strength, biocompatibility, etc.) indicate it is a therapeutic or restorative material, not a diagnostic device.
No
The device description clearly states that TheraCal DC is a "biocompatible, dual-cured, resin-modified calcium silicate," which is a physical material, not software. The performance studies also focus on physical and mechanical properties of this material.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to direct dental procedures performed on a patient's teeth (pulpotomy, filling, repair of perforations, root-end filling, pulp capping, liner/base). These are therapeutic and restorative actions within the body.
- Device Description: The description details a material used to treat damaged dentin within the tooth structure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is used inside the body for treatment and repair.
N/A
Intended Use / Indications for Use
- Pulpotomy
- Temporary Filling Material
- Repair of Root Perforations
- Repair of Furcation Perforations
- Repair of Perforating Internal and External Resorptions
- Root-End Filling in Endodontic Surgery
- Pulp Exposures (Direct Pulp Capping)
- Protective Liner (Indirect Pulp Capping) and Base for Use Under a Variety of Substrates
Product codes (comma separated list FDA assigned to the subject device)
EJK
Device Description
TheraCal DC is a biocompatible, dual-cured, resin-modified calcium silicate that is used to treat damaged dentin in both the crown and the root. TheraCal DC's precise placement allows its use in all deep cavity preparations and endodontic repairs. The dual-cure set permits immediate placement and condensation of the restorative material. Its proprietary formulation allows for a command set with a light curing unit while maintaining ease of placement due to its thixotropic properties.
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
Prescription Use (Part 21 CFR 801 Subpart D)
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)
The following physical/mechanical properties of TheraCal DC were tested: flexural strength (ISO 4049:2009), compressive strength (ANSI/ADA Spec. No. 27:1993 Appendix A2), dimetral tensile strength (in-house test method), working time (in-house test method), bond strength (in-house test method), radiopacity (ISO 4049:2009), water sorption and solubility (ISO 4049:2009 and ISO 6876:2012), calcium release (in-house test method), and pH (in-house test method). An evaluation of biocompatibility of TheraCal DC was conducted using ISO 7405:2008 and ISO 10993-1:2009. Direct comparison testing demonstrates that TheraCal DC is equivalent to the predicate device. It is concluded from the evaluation and the results of the cytotoxicity study that TheraCal DC meets the requirements of the testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 872.3250 Calcium hydroxide cavity liner.
(a)
Identification. A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth.(b)
Classification. Class II.
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April 5, 2018
Bisco, Inc. Ryan Hobson RA Product Registration Manager 1100 West Irving Park Road Schaumburg, Illinois 60193
Re: K180344
Trade/Device Name: TheraCal DC Regulation Number: 21 CFR 872.3250 Regulation Name: Calcium Hydroxide Cavity Liner Regulatory Class: Class II Product Code: EJK Dated: March 5, 2018 Received: March 7, 2018
Dear Ryan Hobson:
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 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 (QS) regulation (21 CFR Part 820);
1
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,
Mary S. Runner -S
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) K180344
Device Name TheraCal DC
Indications for Use (Describe)
-
Pulpotomy
-
Temporary Filling Material
-
Repair of Root Perforations
-
Repair of Furcation Perforations
-
Repair of Perforating Internal and External Resorptions
-
Root-End Filling in Endodontic Surgery
-
Pulp Exposures (Direct Pulp Capping)
-
Protective Liner (Indirect Pulp Capping) and Base for Use Under a Variety of Substrates
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for BISCO. Above the name are five connected hexagons. The first and last hexagons are red, while the middle three are blue. The name BISCO is written in a sans-serif font, with the top half of the letters in gray and the bottom half in black.
Special 510(k) SUMMARY
Bisco, Inc. 1100 W. Irving Park Road Schaumburg IL, 60193
Contact Person:
Ryan Hobson Tel: 847-534-6143 Fax: 847-534-6143
5 March 2018
Date Prepared:
Trade Name: Common Name: Product Code: Classification/Name:
TheraCal DC Dual-Cured Resin-Modified Calcium Silicate Pulp Protectant EJK Liner, Cavity, Calcium Hydroxide Class II per 21 CFR 872.3250
Predicate Devices:
TheraCal DC is substantially equivalent to: TheraCal DC by Bisco Inc. K143292 Primary Predicate:
TheraCal DC is indicated for use for:
-
- Pulpotomy
-
- Temporary Filling Material
-
- Repair of Root Perforations
-
- Repair of Furcation Perforations
-
- Repair of Perforating Internal and External Resorptions
-
- Root-End Filling in Endodontic Surgery
-
- Pulp Exposures (Direct Pulp Capping)
-
- Protective Liner (Indirect Pulp Capping) and Base for Use Under a Variety of Substrates
800-247-3368 or 847-534-6000 Fax: 847-891-5049 www.bisco.com
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Image /page/4/Picture/0 description: The image shows the BISCO company logo. The logo consists of five connected hexagons, with the first and last hexagons being red, the second and fourth being blue, and the middle hexagon being light blue. Below the hexagons is the word "BISCO" in a gray, sans-serif font, with the bottom half of the letters being black.
Special 510(k) SUMMARY (continued)
The indications for use of TheraCal DC are identical to the predicate device.
| TheraCal DC | Modified TheraCal DC |
|---|---|
| (K143292) | |
| TheraCal DC is indicated for use for: | TheraCal DC is indicated for use for: |
| 1. Pulpotomy | 1. Pulpotomy |
| 2. Temporary filling material | 2. Temporary filling material |
| 3. Repair of root perforations | 3. Repair of root perforations |
| 4. repair of furcation perforations | 4. repair of furcation perforations |
| 5. repair of perforating internal and external resorptions | 5. repair of perforating internal and external resorptions |
| 6. apexification | 6. apexification |
| 7. root-end filling in endodontic surgery | 7. root-end filling in endodontic surgery |
| 8. pulp exposures (direct pulp capping) | 8. pulp exposures (direct pulp capping) |
Description of Applicant Device:
TheraCal DC is a biocompatible, dual-cured, resin-modified calcium silicate that is used to treat damaged dentin in both the crown and the root. TheraCal DC's precise placement allows its use in all deep cavity preparations and endodontic repairs. The dual-cure set permits immediate placement and condensation of the restorative material. Its proprietary formulation allows for a command set with a light curing unit while maintaining ease of placement due to its thixotropic properties.
Technological Characteristics:
All components of TheraCal DC are based upon industry standard chemistry. Comparisons of the chemical composition of TheraCal DC to the predicate is provided in the following table:
| Chemical Composition | TheraCal DC
(K143292) | Modified TheraCal DC |
|--------------------------|----------------------------------------------------|----------------------------------------------------|
| Filler | Portland Cement | Portland Cement |
| Resin Composition | Hydrophilic resin to facilitate calcium
release | Hydrophilic resin to facilitate calcium
release |
| Method of polymerization | Dual-Cure | Dual-Cure |
| Method of Application | bonding agent not required | bonding agent not required |
| Ions Released | Calcium and hydroxide | Calcium and hydroxide |
| Physical / Mechanical Property Comparison | TheraCal DC
(K143292) | Modified TheraCal DC |
|-------------------------------------------------|--------------------------|----------------------|
| Radiographic Appearance
(ISO 4049:2009 7.14) | Radiopaque | Radiopaque |
| Ions Released | Calcium releasing | Calcium releasing |
| pH | basic | basic |
| Shelf-Life | 12 months | 18 months |
800-247-3368 or 847-534-6000 Fax: 847-891-5049 www.bisco.com
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Image /page/5/Picture/0 description: The image shows the logo for BISCO. The logo consists of five connected hexagons in a row. The first, third, and fifth hexagons are red, while the second and fourth hexagons are blue. Below the hexagons is the word "BISCO" in a sans-serif font, with the top half of the letters in gray and the bottom half in black.
The primary difference between the subject device and the predicate is the stated shelf life.
Performance Data:
The following physical/mechanical properties of TheraCal DC were tested: flexural strength (ISO 4049:2009), compressive strength (ANSI/ADA Spec. No. 27:1993 Appendix A2), dimetral tensile strength (in-house test method), working time (in-house test method), bond strength (in-house test method), radiopacity (ISO 4049:2009), water sorption and solubility (ISO 4049:2009 and ISO 6876:2012), calcium release (in-house test method), and pH (in-house test method). An evaluation of biocompatibility of TheraCal DC was conducted using ISO 7405:2008 and ISO 10993-1:2009. Direct comparison testing demonstrates that TheraCal DC is equivalent to the predicate device.
It is concluded from the evaluation and the results of the cytotoxicity study that TheraCal DC meets the requirements of the testing.
Conclusion:
It is concluded from review of the predicate device indications, chemical composition, biocompatibility, and physical properties that TheraCal DC is substantially equivalent in safety and effectiveness to the predicate device.
800-247-3368 or 847-534-6000 Fax: 847-891-5049 www.bisco.com