TheraBase, TheraBase Ca
Device Facts
| Record ID | K192007 |
|---|---|
| Device Name | TheraBase, TheraBase Ca |
| Applicant | Bisco, Inc. |
| Product Code | EMA · Dental |
| Decision Date | Mar 17, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3275 |
| Device Class | Class 2 |
Indications for Use
1. Metal crowns, bridges, inlays, onlays (includes porcelain-fused -to- metal and composite-to-metal) 2. Porcelain, Ceramic Crowns, inlays, and onlays (includes alumina and zirconia) 3. Resin crowns, bridges, inlays, and onlays (resin-based composite-ceramic hybrid) 4. Metal (prefabricated or cast) and non-metal/fiber endodontic posts 5. Implant supported restorations 6. Orthodontic Appliances (brackets, bands) 7. Lining and basing applications under restorations
Device Story
TheraBase and TheraBase Ca are self-etching, self-adhesive, dual-cured resin luting cements and base/liners. Used by dental professionals in clinical settings for luting crowns, bridges, inlays, onlays, posts, and orthodontic appliances, or as a base/liner under restorations. Paste/paste delivery system; requires no etching, priming, or bonding. Radiopaque for radiographic identification. Provides calcium (and fluoride in TheraBase) release. Healthcare providers apply the material directly to the prepared surface; the dual-cure mechanism ensures setting. Benefits include reduced chair time and simplified application process compared to traditional multi-step bonding systems.
Clinical Evidence
Bench testing only. Evaluated physical/mechanical properties including bond strength (modified ISO 29022), diametral tensile strength, film thickness (ISO 4049:2009), flexural strength (ISO 4049:2009), radiopacity (ISO 4049:2009), working/setting time, compressive strength, and ion release. Biocompatibility assessed via ISO 7405:2008 and ISO 10993-1, including an oral toxicity study (10 mice, 14 days) showing no toxicity.
Technological Characteristics
Dual-cured, self-adhesive, self-etching resin cement. Composition: Methacrylate-based resin, amorphous silica, and Portland cement. Radiopaque. Delivery: Dual-syringe. Standards: ISO 4049:2009 (film thickness, flexural strength, radiopacity), ISO 7405:2008, ISO 10993-1. No bonding agent required.
Indications for Use
Indicated for dental professionals to cement metal, porcelain, ceramic, or resin crowns, bridges, inlays, onlays, and endodontic posts; to cement implant-supported restorations and orthodontic appliances; and for use as a liner or base under dental restorations.
Regulatory Classification
Identification
Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.
Predicate Devices
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Tuesday, March 17, 2020
Bisco, Inc. Diana Vu RA Registration Specialist 1100 West Irving Park Rd. Schaumburg, Illinois 60193
Re: K192007
Trade/Device Name: TheraBase / TheraBase Ca Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA Dated: December 19, 2019 Received: December 23, 2019
Dear Diana Vu:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 Srivinas 'Nandu' Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K192007
Device Name TheraBase / TheraBase Ca
#### Indications for Use (Describe)
- 1. Metal crowns, bridges, inlays (includes porcelain-fused -to- metal and composite-to-metal)
- 2. Porcelain, Ceramic Crowns, inlays, and onlays (includes alumina and zirconia)
- 3. Resin crowns, bridges, inlays, and onlays (resin-based composite-ceramic hybrid)
- 4. Metal (prefabricated or cast) and non-metal/fiber endodontic posts
- 5. Implant supported restorations
- 6. Orthodontic Appliances (brackets, bands)
- 7. Lining and basing applications under restorations
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/1 description: The image shows the BISCO company logo. The logo consists of five connected hexagons, alternating between red and blue. Below the hexagons is the word "BISCO" in a bold, sans-serif font, with the letters in shades of gray and black.
## 510 (k) SUMMARY
Applicant:
Bisco, Inc. 1100 W. Irving Park Road Schaumburg IL, 60193
Contact Person:
Diana Vu Tel: 847-534-6091 Fax: 847-534-6091
Date Prepared: 19 December 2019
Trade Name: Common Name: Product Code: Classification/Name:
TheraBase; TheraBase Ca Self-Adhesive Calcium Releasing Resin Cement and Base/Liner EMA Dental Cement Class II per 21 CFR 872.3275
## Predicate Devices:
## TheraCem is substantially equivalent to:
| Primary Predicate: | TheraCem by Bisco, Inc. K161256 |
|----------------------|---------------------------------------------------|
| Reference Predicate: | NuSmile Biocem by NuSmile, LTD / Pulpdent K123265 |
## Indications for Use:
- 1. Metal crowns, bridges, inlays and onlays (includes porcelain-fused-to-metal and composite-to-metal)
- 2. Porcelain, Ceramic Crowns, inlays and onlays (includes alumina and zirconia)
- Resin crowns, bridges, inlays and onlays (resin-based composite-ceramic hybrid) 3.
- 4. Metal (prefabricated or cast) and non-metal/fiber endodontic posts
- 5. Implant supported restorations
- Orthodontic Appliances (brackets, bands) 6.
- Lining and basing applications under restorations 7.
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Image /page/4/Picture/1 description: The image shows the logo for BISCO. The logo consists of five connected hexagons, with the first and last hexagons being red, the second and fourth being blue, and the middle one being light blue. Below the hexagons is the word "BISCO" in gray and black lettering, with the bottom half of the letters being black.
# 510 (k) SUMMARY (continued)
The indications for use of TheraBase and TheraBase Ca are the similar to those for TheraCem and NuSmile BioCem and are summarized in the table below:
| TheraCem<br>(K161256) | TheraBase | TheraBase Ca | NuSmile BioCem<br>(K123265) |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Use TheraCem to cement<br>the following:<br>1. Metal crowns,<br>bridges, inlays and<br>onlays (includes<br>porcelain-fused-to-<br>metal and composite-<br>to-metal)<br>2. Porcelain, Ceramic<br>Crowns, inlays and<br>onlays (includes<br>alumina and zirconia)<br>3. Resin crowns,<br>bridges, inlays and<br>onlays (resin-based<br>composite/composite-<br>ceramic hybrid)<br>4. Metal (prefabricated<br>or cast) and non-<br>metal/fiber endodontic<br>posts<br>5. Implant supported<br>restorations<br>6. Orthodontic<br>Appliances (brackets,<br>bands) | 1. Metal crowns,<br>bridges, inlays, onlays<br>(includes porcelain-<br>fused -to- metal and<br>composite-to-metal)<br>2. Porcelain, Ceramic<br>Crowns, inlays, and<br>onlays (includes<br>alumina and zirconia)<br>3. Resin crowns,<br>bridges, inlays, and<br>onlays (resin-based<br>composite/composite-<br>ceramic hybrid)<br>4. Metal (prefabricated<br>or cast) and non-<br>metal/fiber endodontic<br>posts<br>5. Implant supported<br>restorations<br>6. Orthodontic<br>Appliances (brackets,<br>bands)<br>7. Lining and basing<br>applications under<br>restorations | 1. Metal crowns,<br>bridges, inlays, onlays<br>(includes porcelain-<br>fused -to- metal and<br>composite-to-metal)<br>2. Porcelain, Ceramic<br>Crowns, inlays, and<br>onlays (includes<br>alumina and zirconia)<br>3. Resin crowns,<br>bridges, inlays, and<br>onlays (resin-based<br>composite/composite-<br>ceramic hybrid)<br>4. Metal (prefabricated<br>or cast) and non-<br>metal/fiber endodontic<br>posts<br>5. Implant supported<br>restorations<br>6. Orthodontic<br>Appliances (brackets,<br>bands)<br>7. Lining and basing<br>applications under<br>restorations | Pulpdent RMGI Low<br>Viscosity is a resin-<br>modified glass ionomer<br>preparation used by dental<br>professionals as a liner,<br>base or luting material in<br>dental restorations. |
The only change in the indication for use from TheraCem to TheraBase and TheraBase Ca is the addition of "Lining and basing applications under restorations." NuSmile BioCem is added as a reference predicate to demonstrate that it does not raise new questions of safety and effectiveness as it contains the same indication listed as "liner, base."
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Image /page/5/Picture/1 description: The image shows the BISCO company logo on the left side of the image. The logo consists of a series of red and blue hexagons, followed by the word "BISCO" in large, bold letters. To the right of the logo, the text "510 (k) SUMMARY (continued)" is visible. The background of the image is white, with a faint pattern of hexagons in the upper right corner.
#### Description of Applicant Device:
TheraBase and TheraBase Ca are a self-etching, self-adhesive, dual-cured resin luting cement and base/liner that is exclusively formulated for luting crowns, bridges, inlays, onlays and posts (prefabricated metal and non-metal/fiber posts, as well as cast posts) and basing/lining under restorations. TheraBase is a paste/paste, fluoride- and calcium-releasing, luting cement and base/liner which requires no etching, no priming or bonding of the prepared surfaces. TheraBase Ca is a paste/paste, calcium-releasing, luting cement and base/liner which requires no etching, no priming or bonding of the prepared surfaces. They are easy-to use, require only a short chair time, and produce a good bond to most dental materials. The cements are available in a Natural shade. They are radiopaque, allowing for easy identification on radiographs.
#### Technological Characteristics:
All components of TheraBase and TheraBase Ca are based upon industry standard chemistry. The chemical composition of TheraBase is the same as TheraCem. The chemical composition of TheraBase Ca is similar to TheraCem. The chemical composition of TheraBase and TheraBase Ca is similar to NuSmile BioCem. The chemical compositon of each product is summarized in the table below:
| Chemical<br>Composition | TheraCem<br>(K161256) | NuSmile BioCem<br>(K123265) | TheraBase | TheraBase Ca |
|--------------------------|---------------------------------------|-------------------------------------|---------------------------------------|---------------------------------------|
| Filler | Amorphous Silica &<br>Portland Cement | Amorphous Silica | Amorphous Silica &<br>Portland Cement | Amorphous Silica &<br>Portland Cement |
| Resin composition | Methacrylate based | Methacrylate based | Methacrylate based | Methacrylate based |
| Polymerization<br>Method | Dual cured | Dual cured | Dual cured | Dual cured |
| Method of<br>Application | Bonding agent not<br>required | Bonding agent not<br>required | Bonding agent not<br>required | Bonding agent not<br>required |
| Ions Released | Calcium and fluoride | Calcium, phosphate,<br>and fluoride | Calcium and<br>fluoride | Calcium |
| Physical Mechanical<br>Property | TheraCem<br>(K161256) | NuSmile BioCem<br>(K123265) | TheraBase | TheraBase Ca |
|---------------------------------|-----------------------------------|-----------------------------------|-----------------------------------|-------------------|
| Radiographic<br>Appearance | Radiopaque | Radiopaque | Radiopaque | Radiopaque |
| Ions Released | Fluoride and<br>calcium releasing | Fluoride and<br>calcium releasing | Fluoride and<br>calcium releasing | Calcium releasing |
| Delivery system | Dual-syringe | Dual-syringe | Dual-syringe | Dual-syringe |
The difference in filler is TheraCem's, TheraBase's, and TheraBase Ca's additional use of Portland cement, an industry standard chemical, to facilitate calcium release and is substantially equivalent in performance to amorphous silica.
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Image /page/6/Picture/1 description: The image shows the logo for BISCO. The logo consists of a series of connected hexagons in red and blue, above the word "BISCO" in gray and black. The hexagons appear to be 3D, with shading to give them depth.
510 (k) SUMMARY (continued)
#### Performance Data:
| The following physical/mechanical properties of TheraBase and TheraBase Ca were tested: | | |
|-----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Physical / Mechanical Property | TheraBase | TheraBase Ca |
| Bond Strength<br>(Modified ISO 29022<br>and<br>Gel-Cap method) | TheraBase is higher than or<br>equivalent to 6.9 MPa, and bond<br>to all the substrates. | TheraBase Ca is higher than or<br>equivalent to 6.9 MPa, and bond<br>to all the substrates. |
| Diametral Tensile<br>Strength | TheraBase is greater than or<br>equal to 32 MPa. | TheraBase Ca is greater than or<br>equal to 32 MPa. |
| Film Thickness<br>(ISO 4049:2009) | TheraBase is < 35 µm which<br>meets the ISO 4049:2009<br>requirement of < 50 µm. | TheraBase Ca is < 35 µm which<br>meets the ISO 4049:2009<br>requirement of < 50 µm. |
| Flexural Strength<br>(ISO 4049:2009) | TheraBase is greater than the<br>minimum flexural strength of 50<br>MPa. | TheraBase Ca is greater than the<br>minimum flexural strength of 50<br>MPa. |
| Radiopacity<br>(ISO 4049:2009) | TheraBase is greater than or<br>equal to 2.0. | TheraBase Ca is greater than or<br>equal to 2.0. |
| Working Time /<br>Setting Time | TheraBase is greater than the<br>minimum working time of 1 minute<br>at room temperature (22±1°C)<br>and is less than the maximum<br>setting time of 5 minutes at<br>37±1°C. | TheraBase Ca is greater than the<br>minimum working time of 1 minute<br>at room temperature (22±1°C) and<br>is less than the maximum setting<br>time of 5 minutes at 37±1°C. |
| Compressive<br>Strength | TheraBase is equivalent to or<br>greater than 189 MPa. | TheraBase Ca is equivalent to or<br>greater than 189 MPa. |
| Calcium Release | TheraBase releases calcium<br>greater than or equal to 3.3 µg<br>Ca/cm². | TheraBase Ca releases calcium<br>greater than or equal to 3.3 µg<br>Ca/cm². |
| Fluoride Release | TheraBase releases fluoride. | N/A, TheraBase Ca does not<br>contain fluoride |
## Biocompatibility:
An evaluation of biocompatibility was conducted using ISO 7405:2008 and ISO 10993-1 to determine the safety of TheraBase and TheraBase Ca. It is concluded from the safety evaluation and the results of the Oral Toxicity Study (10 mice, 14 days) that TheraBase and TheraBase Ca were not toxic in this test.
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Image /page/7/Picture/1 description: The image shows the logo for BISCO. The logo consists of five connected hexagons, with the two outer hexagons being red and the three inner hexagons being blue. Below the hexagons is the word "BISCO" in a sans-serif font, with the top half of the letters being gray and the bottom half being black. The number 5 is in the bottom right corner of the image.
510 (k) SUMMARY (continued)
## Conclusion:
It is concluded from review of the predicate device indications, chemical composition, biocompatibility, and physical properties that TheraBase and TheraBase Ca are substantially equivalent to the predicate devices.
800-247-3368 or 847-534-6000 Fax: 847-891-5049 www.bisco.com
