CeraClean is an extraoral cleaner of pre-treated ceramic, zirconia and metal restoration surfaces which have been contaminated during intraoral try-in.

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.

AI/ML Overview

The provided text describes a 510(k) summary for the CeraClean device, which is an extraoral cleaner for dental restoration surfaces. The study presented aims to demonstrate substantial equivalence to a predicate device, Resolve 2.0.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a typical clinical study sense with quantitative thresholds for sensitivity, specificity, and so on. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and performance data. The implicit acceptance criterion is that CeraClean's performance must be "substantially equivalent" to that of the predicate device, Resolve 2.0, across various relevant parameters.

Acceptance Criterion (Implicit: Substantial Equivalence to Predicate)	Reported Device Performance (CeraClean)
Indications for Use:
- Extraoral cleaner for dental restorations.	- Extraoral cleaner of pre-treated ceramic, zirconia, and metal restoration surfaces which have been contaminated during intraoral try-in. (Stated as substantially equivalent)
Chemical Composition:
- Water Solubility	- Water Soluble (Explicitly stated as substantially equivalent to predicate)
- pH after rinsing (Neutral)	- pH = 7 (Predicate: pH = 7; Stated as substantially equivalent to predicate)
Physical/Mechanical Properties:
- Shear Bond Strength (removes saliva contamination)	- Removes saliva contamination (Explicitly stated as substantially equivalent to predicate based on modified ISO 29022:2013)
- Water Solubility	- Water Soluble (Explicitly stated as substantially equivalent to predicate)
- Method of application (Syringe tip w/brush)	- Syringe tip or brush (Similar, within equivalence)
- Method of removal (Water spray & air dried)	- Water spray & air dried (Identical)
- Removal from substrate (SEM EDX)	- Demonstrates device is removed from substrate.
Biocompatibility:
- Meets biocompatibility requirements.	- Met the requirements of the test (ISO 7405:2008 and ISO 10993-1:2009 cytotoxicity testing)

Note on Differences: The document acknowledges differences in chemical composition (e.g., CeraClean is water-based gel with xanthum gum and potassium hydroxide vs. acrylate resin-based with silicate and chlorohexidine for Resolve 2.0; CeraClean is non-abrasive while Resolve 2.0 is abrasive). However, it argues these differences do not raise new questions of safety or effectiveness as both are water soluble, used outside the mouth, and rinsed off.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size for the test set. For the shear bond strength test based on modified ISO 29022:2013, it implies that the device was tested, but the number of samples or cases is not provided. Similarly, for water solubility, pH, and SEM EDX, specific sample sizes are not mentioned.

The data provenance is not specified. It's likely an in-house or contracted laboratory study, but the country of origin or whether it's retrospective or prospective data is not detailed. Given the nature of a 510(k) submission for a cleaning solution, this would typically involve laboratory testing rather than human subject data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. For a product like CeraClean, "ground truth" might refer to analytical chemistry results or physical property measurements rather than expert interpretations of images or clinical outcomes. The document relies on established ISO standards (ISO 29022:2013 for bond strength, ISO 7405:2008 and ISO 10993-1:2009 for biocompatibility) for its performance claims, implying that adherence to these standards constitutes the "ground truth" of performance evaluation.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method. Given that the tests are laboratory-based (shear bond strength, pH, water solubility, SEM EDX, biocompatibility), results would typically be quantitative and objectively measured, not requiring expert adjudication in the same way clinical imaging studies do.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human interpretation is involved. CeraClean is an extraoral cleaning solution, and its performance is evaluated through material science and biocompatibility tests.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was done

The performance tests conducted (Shear Bond Strength, Water Solubility, pH, SEM EDX, Biocompatibility) are standalone laboratory tests of the device's physical and chemical properties. There is no "human-in-the-loop" component to these performance measurements as they assess the intrinsic properties and effectiveness of the cleaning solution itself.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation appears to be based on:

Established material science standards and measurements: e.g., modified ISO 29022:2013 for shear bond strength, direct measurements for pH and water solubility, SEM EDX for residue removal.
Biocompatibility standards: ISO 7405:2008 and ISO 10993-1:2009.

This is not expert consensus, pathology, or outcomes data in the clinical sense, but rather objective, repeatable measurements under controlled laboratory conditions referencing international standards.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device or study design. Training sets are used in machine learning or AI algorithm development. CeraClean is a physical cleaning solution, not a software algorithm.

9. How the Ground Truth for the Training Set Was Established

As there is no training set, this question is not applicable.

Summary

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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

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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 RoadSchaumburg IL, 60193
Contact Person:	Ryan HobsonBisco, Inc.1100 W. Irving Park RoadSchaumburg IL, 60193Tel: 847-534-6143Fax: 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:

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 2.0K152322 (predicate device)	CeraClean
Resolve 2.0 is recommended for use on dentalrestorations, external to the mouth, prior toinsertion into the mouth. After applyingResolve 2.0 to cleanse the restoration, thesurface of the restoration should be washedthoroughly with water, and then air driedbefore placement in the mouth.	CeraClean is an extraoral cleaner of pre-treatedceramic, zirconia and metal restorationsurfaces which have been contaminated duringintraoral 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 2.0K152322 (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

K163171

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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 / MechanicalProperty	Resolve 2.0K152322 (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 / MechanicalProperty	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

Regulation Number and Section

§ 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.