(86 days)
No
The summary describes a dental luting cement and its physical/mechanical properties, with no mention of AI or ML capabilities.
No
The device is a dental luting cement used for cementing crowns, bridges, inlays, onlays, and posts, which are restorative and prosthetic procedures, not therapies aiming to cure or treat diseases.
No
TheraCem is described as a luting cement used for cementing various dental restorations and appliances, not for diagnosing medical conditions. Its use of radiographs is for identifying the cement after placement, not for diagnostic imaging of the patient.
No
The device description clearly states it is a "self-etching, self-adhesive, dual-cured resin luting cement," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a dental cement for luting various dental restorations and appliances. This is a direct application within the body (or on structures within the body like teeth), not for testing samples taken from the body.
- Device Description: The description reinforces its use as a luting cement for dental procedures.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease, condition, or state of health. It is a therapeutic/restorative material.
- Performance Studies: The performance studies focus on physical and mechanical properties relevant to a dental cement (bond strength, film thickness, flexural strength, etc.) and biocompatibility, not on diagnostic accuracy or analytical performance.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Use TheraCem to cement the following:
-
- Metal crowns, bridges, inlays and onlays (includes porcelain-fused-to-metal and composite-to-metal)
-
- Porcelain, Ceramic Crowns, inlays and onlays (includes alumina and zirconia)
-
- Resin crowns, bridges, inlays and onlays (resin-based composite-ceramic hybrid)
-
- Metal (prefabricated or cast) and non-metal/fiber endodontic posts
-
- Implant supported restorations
-
- Orthodontic Appliances (brackets, bands)
Product codes (comma separated list FDA assigned to the subject device)
EMA
Device Description
TheraCem is a self-etching, self-adhesive, dual-cured resin luting cement that is exclusively formulated for luting crowns, bridges, inlays, onlays and posts (prefabricated metal and nonmetal/fiber posts, as well as cast posts). TheraCem is a paste/paste, fluoride- and calciumreleasing, luting cement which requires no etching, no priming or bonding of the prepared surfaces. It is easy-to use, requires only a short chair time, and produces a good bond to most dental materials. The cement is available in a Natural shade. It is radiopaque, allowing for easy identification on radiographs.
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
Not Found
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 TheraCem were tested:
- Bond Strength (Modified ISO 29022 and Gel-Cap method): TheraCem is equivalent to the predicates.
- Diametral Tensile Strength: TheraCem is equivalent to the predicates.
- Film Thickness (ISO 4049:2009): TheraCem meets the requirements of ISO 4049:2009 for Film Thickness.
- Flexural Strength (ISO 4049:2009): TheraCem meets the requirements of ISO 4049:2009 for Flexural Strength.
- Radiopacity (ISO 4049:2009): TheraCem meets the requirements of ISO 4049:2009 for Radiopacity.
- Working Time / Setting Time: TheraCem is equivalent to the predicates.
- Compressive Strength: TheraCem is equivalent to the predicates.
- Calcium Release: TheraCem is equivalent to the predicates.
- Fluoride Release: TheraCem is equivalent to the predicates.
Biocompatibility: An evaluation of biocompatibility was conducted using ISO 7405:2008 and ISO 10993-1 to determine the safety of TheraCem. It is concluded from the safety evaluation and the results of the Oral Toxicity Study (10 mice, 14 days) that TheraCem was not toxic in this test.
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.
BisCem by Bisco, Inc. K082449
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.
NuSmile Biocem by NuSmile, LTD / Pulpdent K123265
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)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.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. 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.(2)
Classification. Class II.
0
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, creating a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 29, 2016
Bisco, Inc. Ryan Hobson RA Registration Coordinator 1100 West Irving Park Road Schaumburg, Illinois 60193
Re: K161256
Trade/Device Name: Theracem Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA, Dated: May 2, 2016 Received: May 4, 2016
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 (reporting of medical devicerelated 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.
1
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/ResourcesforYou/Industry/default.htm. 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.
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,
Image /page/1/Picture/7 description: The image shows the name "Susan Kunna DDS, MA" in a handwritten-like font. The text is in black ink and appears to be a signature or a title. The letters are connected, giving it a cursive appearance.
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
2
Indications for Use
510(k) Number (if known)
Device Name TheraCem
Indications for Use (Describe)
Use TheraCem to cement the following:
-
- Metal crowns, bridges, inlays and onlays (includes porcelain-fused-to-metal and composite-to-metal)
-
- Porcelain, Ceramic Crowns, inlays and onlays (includes alumina and zirconia)
-
- Resin crowns, bridges, inlays and onlays (resin-based composite-ceramic hybrid)
-
- Metal (prefabricated or cast) and non-metal/fiber endodontic posts
-
- Implant supported restorations
-
- Orthodontic Appliances (brackets, bands)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 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 a gradient of red and blue, and the middle hexagon being blue. Below the hexagons is the word "BISCO" in a bold, sans-serif font, with the top half of the letters in gray and the bottom half in black.
510 (k) SUMMARY
Applicant:
Bisco, Inc. 1100 W. Irving Park Road Schaumburg IL, 60193
Contact Person:
Ryan Hobson Tel: 847-534-6143 Fax: 847-534-6143
02 May 2016
Date Prepared:
Trade Name: Common Name: Product Code: Classification/Name:
TheraCem Self-Adhesive Resin Cement EMA Dental Cement Class II per 21 CFR 872.3275
Predicate Devices:
TheraCem is substantially equivalent to:
| Primary Predicate: | BisCem by Bisco, Inc. K082449 |
|---|---|
| Reference Predicate: | NuSmile Biocem by NuSmile, LTD / Pulpdent K123265 |
Indications for Use:
Use TheraCem to cement the following:
-
- Metal crowns, bridges, inlays and onlays (includes porcelain-fused-to-metal and composite-to-metal)
- Porcelain, Ceramic Crowns, inlays and onlays (includes alumina and zirconia) 2.
-
- Resin crowns, bridges, inlays and onlays (resin-based composite-ceramic hybrid)
-
- Metal (prefabricated or cast) and non-metal/fiber endodontic posts
-
- Implant supported restorations
-
- Orthodontic Appliances (brackets, bands)
BISCO, Inc. 1100 W. Irving Park Road Schaumburg, IL 60193 U.S.A.
4
Image /page/4/Picture/0 description: The image shows the BISCO company logo. The logo consists of a series of connected, three-dimensional, hexagonal shapes in red and blue. Below the shapes, the word "BISCO" is written in a bold, sans-serif font, with the letters in gray and black.
510 (k) SUMMARY (continued)
The indications for use of TheraCem are the same as those for BisCem and NuSmile BioCem and are summarized in the table below:
| | BisCem
(K082449) | TheraCem | NuSmile BioCem
(K123265) |
|--|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Luting metal crowns, bridges, inlay, and onlays including porcelain-fused-to-metal and composite-to-metal varieties Luting resin crowns, bridges, inlays, onlays, and veneers; Luting metal or non-metal/fiber posts; Luting orthodontic appliances; Luting porcelain inlays, onlays, crowns, and veneers (includes alumina and zirconia) | Use TheraCem to cement the following:
Metal crowns, bridges, inlays and onlays (includes porcelain-fused-to-metal and composite-to-metal) Porcelain, Ceramic Crowns, inlays and onlays (includes alumina and zirconia) Resin crowns, bridges, inlays and onlays (resin-based composite/composite-ceramic hybrid) Metal (prefabricated or cast) and non-metal/fiber endodontic posts Implant supported restorations Orthodontic Appliances (brackets, bands) | Pulpdent RMGI Low Viscosity is a resin-modified glass ionomer preparation used by dental professionals as a liner, base or luting material in dental restorations. |
Description of Applicant Device:
TheraCem is a self-etching, self-adhesive, dual-cured resin luting cement that is exclusively formulated for luting crowns, bridges, inlays, onlays and posts (prefabricated metal and nonmetal/fiber posts, as well as cast posts). TheraCem is a paste/paste, fluoride- and calciumreleasing, luting cement which requires no etching, no priming or bonding of the prepared surfaces. It is easy-to use, requires only a short chair time, and produces a good bond to most dental materials. The cement is available in a Natural shade. It is radiopaque, allowing for easy identification on radiographs.
BISCO, Inc. 1100 W. Irving Park Road Schaumburg, IL 60193 U.S.A.
5
Image /page/5/Picture/0 description: The image shows the logo for BISCO. The logo consists of a series of connected, three-dimensional hexagonal shapes in red, light blue, and dark blue. Below the shapes is the word "BISCO" in a bold, sans-serif font, with the top half of the letters in gray and the bottom half in black.
510 (k) SUMMARY (continued)
Technological Characteristics:
All components of TheraCem are based upon industry standard chemistry. The chemical composition of TheraCem is similar to BisCem and BioCem and is summarized in the table below:
| Chemical Composition | BisCem
(K082449) | NuSmile BioCem
(K123265) | TheraCem |
|-----------------------|-------------------------------|-------------------------------------|---------------------------------------|
| Filler | Amorphous Silica | Amorphous Silica | Amorphous Silica &
Portland Cement |
| Resin composition | Methacrylate based | Methacrylate based | Methacrylate based |
| Polymerization Method | Dual cured | Dual cured | Dual cured |
| Method of Application | Bonding agent not
required | Bonding agent not
required | Bonding agent not
required |
| Ions Released | Fluoride | Calcium, phosphate, and
fluoride | Calcium and fluoride |
| Physical Mechanical
Property | BisCem
(K082449) | NuSmile BioCem
(K123265) | TheraCem |
|---------------------------------|---------------------|-----------------------------------|-----------------------------------|
| Radiographic Appearance | Radiopaque | Radiopaque | Radiopaque |
| Ions Released | Fluoride releasing | Fluoride and calcium
releasing | Fluoride and calcium
releasing |
| Delivery system | Dual-syringe | Dual-syringe | Dual-syringe |
The difference in filler is TheraCem's use of Portland cement, an industry standard chemical, to facilitate calcium release and is substantially equivalent in performance to amorphous silica. A reference predicate, BioCem (K123265), has been included to demonstrate substantial equivalence for calcium releasing.
BISCO, Inc. 1100 W. Irving Park Road Schaumburg, IL 60193 U.S.A.
6
Image /page/6/Picture/0 description: The image shows the logo for BISCO. 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 (continued)
Performance Data:
The following physical/mechanical properties of TheraCem were tested:
| Physical / Mechanical Property | TheraCem |
|---|---|
| Bond Strength | |
| (Modified ISO 29022 and | |
| Gel-Cap method) | TheraCem is equivalent to the predicates. |
| Diametral Tensile Strength | TheraCem is equivalent to the predicates. |
| Film Thickness | |
| (ISO 4049:2009) | TheraCem meets the requirements of ISO 4049:2009 for Film |
| Thickness. | |
| Flexural Strength | |
| (ISO 4049:2009) | TheraCem meets the requirements of ISO 4049:2009 for |
| Flexural Strength. | |
| Radiopacity | |
| (ISO 4049:2009) | TheraCem meets the requirements of ISO 4049:2009 for |
| Radiopacity. | |
| Working Time / Setting Time | TheraCem is equivalent to the predicates. |
| Compressive Strength | TheraCem is equivalent to the predicates. |
| Calcium Release | TheraCem is equivalent to the predicates. |
| Fluoride Release | TheraCem is equivalent to the predicates. |
Biocompatibility:
An evaluation of biocompatibility was conducted using ISO 7405:2008 and ISO 10993-1 to determine the safety of TheraCem. It is concluded from the safety evaluation and the results of the Oral Toxicity Study (10 mice, 14 days) that TheraCem was not toxic in this test.
Conclusion:
It is concluded from review of the predicate device indications, chemical composition, biocompatibility, and physical properties that TheraCem is substantially equivalent to the predicate devices.
BISCO, Inc. 1100 W. Irving Park Road Schaumburg, IL 60193 U.S.A.