(151 days)
Not Found
No
The summary describes a cleaning gel and its performance in terms of bond strength and solubility, with no mention of AI or ML.
No
CeraClean is described as an "extraoral cleaner" for pre-treated restoration surfaces contaminated during try-in, and its function is "non-abrasive cleaning." It is used outside the mouth and applied to prosthetic restorations, not directly to a patient to treat a condition or disease.
No
The device is described as an "extraoral cleaner" for dental restoration surfaces and applied before final placement. It performs a cleaning function, not a diagnostic one. The performance studies evaluate bond strength and material properties, not diagnostic accuracy.
No
The device description clearly states it is a "cleaning gel" and is "applied through a single-use tip or application," indicating it is a physical substance and delivery mechanism, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to clean the surfaces of dental restorations extraorally after intraoral try-in. This is a physical cleaning process performed outside the body.
- Device Description: The description reinforces that it's an extraoral cleaning gel applied to prosthetic restorations.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease, condition, or state of health. It does not analyze biological samples or provide information about a patient's health status.
- Performance Studies: The performance studies focus on the device's ability to clean and its impact on bond strength, water solubility, and pH – all related to its function as a cleaning agent for dental materials, not for diagnostic purposes.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. CeraClean does not fit this description.
N/A
Intended Use / Indications for Use
CeraClean is an extraoral cleaner of pre-treated ceramic, zirconia and metal restoration surfaces which have been contaminated during intraoral try-in.
Product codes (comma separated list FDA assigned to the subject device)
PME
Device Description
CeraClean is used outside the mouth, as an extraoral cleaning gel suitable for non-abrasive cleaning of the bonding surfaces of prosthetic restorations after intraoral try-in. CeraClean is applied through a single-use tip or application to the prosthetic restorations and rinsed off prior to the application of a primer or cement for final placement of the restoration.
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)
Shear bond strength was tested based upon ISO 29022:2013 Dentistry - Adhesion - Notchededge shear bond strength test. Additionally, water solubility and pH (before and after rinse) were tested. A comparison of the physical/mechanical properties of CeraClean to the predicate device is provided in the table below.
| Physical / Mechanical Property | CeraClean |
|---|---|
| Shear Bond Strength (modified ISO 29022:2013) | Substantially equivalent to the predicate device. |
| Water Solubility | Substantially equivalent to the predicate device. |
| pH (before rinse / after rinse) | Predicate: pH = 6/7, CeraClean pH = 14/7 |
| SEM EDX | Demonstrates device is removed from substrate. |
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
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 14, 2017
Bisco, Inc. Ryan Hobson Regulatory Affairs Product Registration Coordinator 1100 West Irving Park Road Schaumburg, Illinois 60193
Re: K163171
Trade/Device Name: CeraClean Regulation Number: 21 CFR 872.3260 Regulation Name: External Cleaning Solution Regulatory Class: Class II Product Code: PME Dated: March 23, 2017 Received: March 20, 2017
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
1
the quality systems (OS) 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/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,
Michael J. Ryan -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) K163171
Device Name CeraClean
Indications for Use (Describe)
Ceraclean is an extraoral cleaner of pre-treated ceramic, zirconia and metal restoration surfaces which have been contaminated during intraoral try-in.
| Type of Use (Select one or both, as applicable) |
|---|
| Research Use (Per 21 CFR 801.3 and/or R) |
| For In-Vitro Use Only (21 CFR 801.5 and/or G) |
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. The logo consists of five connected, three-dimensional hexagonal shapes. The shapes alternate in color between red and blue. Below the shapes is the word "BISCO" in a gray, sans-serif font. The letters are bold and slightly rounded.
510(k) SUMMARY
| Applicant: | Bisco, Inc.
1100 W. Irving Park Road
Schaumburg IL, 60193 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ryan Hobson
Bisco, Inc.
1100 W. Irving Park Road
Schaumburg IL, 60193
Tel: 847-534-6143
Fax: 847-534-6143 |
| Date Prepared: | 13 April 2017 |
| Trade Name: | CeraClean |
| Common Name: | Restoration Cleaner |
| Product Code: | PME |
Predicate Device:
Classification/Name:
Resolve 2.0, K152322 by Denali Corporation
CeraClean Indication for Use:
CeraClean is an extraoral cleaner of pre-treated ceramic, zirconia and metal restoration surfaces which have been contaminated during intraoral try-in.
External Cleaning Solution
Class II per 21 CFR 872.3260
Description of Applicant Device:
CeraClean is used outside the mouth, as an extraoral cleaning gel suitable for non-abrasive cleaning of the bonding surfaces of prosthetic restorations after intraoral try-in. CeraClean is applied through a single-use tip or application to the prosthetic restorations and rinsed off prior to the application of a primer or cement for final placement of the restoration.
BISCO, Inc. 1100 W. Irving Park Road Schaumburg, IL 60193 U.S.A.
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, colored in red and blue. Below the hexagons, the word "BISCO" is written in bold, gray letters, with the bottom portion of the letters in black.
510(k) SUMMARY (continued)
Comparison of Technological Characteristics:
Indications for Use
| Resolve 2.0
| K152322 (predicate device) | CeraClean |
|---|---|
| Resolve 2.0 is recommended for use on dental | |
| restorations, external to the mouth, prior to | |
| insertion into the mouth. After applying | |
| Resolve 2.0 to cleanse the restoration, the | |
| surface of the restoration should be washed | |
| thoroughly with water, and then air dried | |
| before placement in the mouth. | CeraClean is an extraoral cleaner of pre-treated |
| ceramic, zirconia and metal restoration | |
| surfaces which have been contaminated during | |
| intraoral try-in. |
CeraClean's Indications for Use Statement does not include the cleaning information included in the predicate's statement and list pre-treated ceramic, zirconia and metal restorations instead of just general restorations. These differences are not critical to the intended use of the subject device as equivalent cleaning instructions are included within the instructions for use. The increased specificity list the most common materials used in dental prosthetic restorations and fall within the general indication and no not alter the device risk. The subject device is just as safe and effective as compared to the predicate device.
Chemical Composition
| Chemical Composition | Resolve 2.0
K152322 (predicate device) | CeraClean |
|----------------------|-------------------------------------------|---------------------|
| Composition | Acrylate resin based gel | Water based gel |
| Viscosity modifier | Silicate | Xanthum Gum |
| Active ingredient | Chlorohexidine | Potassium Hydroxide |
| pH after rinsing | Neutral | Neutral |
| Water Solubility | Water Soluble | Water Soluble |
| Pigmented | Yes - Pink | Yes - Blue |
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 BISCO company logo. The logo consists of five connected hexagons, alternating in color between red and blue. Below the hexagons is the word "BISCO" in a bold, sans-serif font, with the letters in gray and black.
510(k) SUMMARY (continued)
Comparison of Technological Characteristics (continued):
| Physical / Mechanical
Property | Resolve 2.0
K152322 (predicate device) | CeraClean |
|--------------------------------------------------|-------------------------------------------|------------------------------|
| Shear Bond Strength
(modified ISO 29022:2013) | Removes saliva contamination | Removes saliva contamination |
| Method of application | Syringe tip w/brush | Syringe tip or brush |
| Method of cleaning | Abrasive | Non-abrasive |
| Method of Removal | Water spray & air dried | Water spray & air dried |
| Delivery configuration | Syringe | Syringe or Bottle |
| Removal | Water Soluble | Water Soluble |
The major differences between Resolve 2.0 and CeraClean are that Resolve 2.0 is a pigmented acrylate resin based gel that uses silicate as a viscosity modifier, includes Chlorohexidine, and is abrasive. CeraClean however, is a pigmented water based gel that uses xanthum gum as a viscosity modifier and does not require abrasive scrubbing to clean the substrate of saliva contamination in preparation for final restoration placement. The lack of acrylate resins in CeraClean does not raise new questions of safety or effectiveness as both devices are water soluble, used outside the mouth, and rinsed off the restorative device prior to placement in the mouth. CeraClean does not include the antimicrobial agent Chlorohexidine. Both devices are pigmented, water soluble, and cleaned substrates are neutral after rinsing.
BISCO, Inc. 1100 W. Irving Park Road Schaumburg, IL 60193 U.S.A.
800-247-3368 or 847-534-6000 Fax: 847-891-5049 www.bisco.com
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Image /page/6/Picture/0 description: The image shows the logo for BISCO. The logo consists of five geometric shapes arranged horizontally, with the first and last shapes being red, the second and fourth shapes being blue, and the middle shape being a lighter shade of blue. Below the shapes is the word "BISCO" in a bold, sans-serif font, with the "BI" in gray and the "SCO" in black.
510(k) SUMMARY (continued)
Performance Data:
Shear bond strength was tested based upon ISO 29022:2013 Dentistry - Adhesion - Notchededge shear bond strength test. Additionally, water solubility and pH (before and after rinse) were tested. A comparison of the physical/mechanical properties of CeraClean to the predicate device is provided in the table below.
| Physical / Mechanical
| Property | CeraClean |
|---|---|
| Shear Bond Strength | |
| (modified ISO 29022:2013) | Substantially equivalent to the predicate device. |
| Water Solubility | Substantially equivalent to the predicate device. |
| pH (before rinse / after rinse) | Predicate: pH = 6/7, CeraClean pH = 14/7 |
| SEM EDX | Demonstrates device is removed from substrate. |
Biocompatibility:
An evaluation of biocompatibility was conducted using ISO 7405:2008 and ISO 10993-1:2009. It is concluded from the biocompatibility evaluation and the results of the cytotoxicity testing that CeraClean met the requirements of the test.
Conclusion:
It is concluded that the information supplied in this submission has demonstrated that CeraClean is substantially equivalent in design, composition, performance, and intended use to the legally marketed predicate device.
BISCO, Inc. 1100 W. Irving Park Road Schaumburg, IL 60193 U.S.A.
800-247-3368 or 847-534-6000 Fax: 847-891-5049 www.bisco.com