Choice 2 DC is a color stable dual-cured, resin luting/veneering cement that is specially formulated for the cementation of indirect restorations made from Glass Ceramic, Lithium Disilicate, Porcelain, Composite, Metal, or Zirconia.

AI/ML Overview

The provided FDA 510(k) clearance letter for Choice 2 DC, a dental cement, does not contain information about a study proving the device meets acceptance criteria in the context of an AI/ML algorithm or similar diagnostic device. The document explicitly states:

"Clinical testing is Not Applicable."

Instead, the submission relies on non-clinical testing to demonstrate substantial equivalence to predicate and reference devices. The acceptance criteria for this device are based on performance metrics defined by ISO standards for dental cements, rather than diagnostic accuracy metrics.

Therefore, many of the requested elements for describing an acceptance criteria study related to AI/ML or diagnostic performance (e.g., sample size for test set, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this specific 510(k) clearance.

However, I can still extract details about the non-clinical testing and the "acceptance criteria" as implied by the standards chosen for comparison:

Non-Clinical Performance Study Details for Choice 2 DC Dental Cement

The provided FDA 510(k) summary for Choice 2 DC Dental Cement describes non-clinical testing performed to demonstrate substantial equivalence to predicate and reference devices.

1. Table of Acceptance Criteria and Reported Device Performance

For this dental cement, "acceptance criteria" are implied by adherence to established ISO standards and performance at least equal to predicate devices. The document does not provide specific numerical "reported device performance" values for each test, but states that the device met the requirements of the ISO standard and performed at least equal to predicate and reference devices.

Performance Metric (Acceptance Criteria per ISO 4049:2019)	Reported Device Performance
Film thickness	Met requirements of ISO 4049:2019 and performed at least equal to predicate/reference devices.
Working time	Met requirements of ISO 4049:2019 and performed at least equal to predicate/reference devices.
Setting time	Met requirements of ISO 4049:2019 and performed at least equal to predicate/reference devices.
Flexural strength	Met requirements of ISO 4049:2019 and performed at least equal to predicate/reference devices.
Water sorption	Met requirements of ISO 4049:2019 and performed at least equal to predicate/reference devices.
Water solubility	Met requirements of ISO 4049:2019 and performed at least equal to predicate/reference devices.
Shade/color stability	Met requirements of ISO 4049:2019 and performed at least equal to predicate/reference devices.
Radiopacity	Met requirements of ISO 4049:2019 and performed at least equal to predicate/reference devices.
Shear bond strength (per ISO 29022:2013)	Performed at least equal to predicate/reference devices. (ISO 29022:2013 is a test standard, not necessarily defining a singular "requirement" like ISO 4049 for certain properties, but rather a methodology for comparison).

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

Sample Size: Not explicitly stated in the 510(k) summary. These details would typically be found in the full test reports referenced by the ISO standards.
Data Provenance: The testing was non-clinical (laboratory testing of material properties). Therefore, concepts like country of origin or retrospective/prospective collection are not applicable.

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

Not applicable. This was non-clinical material testing based on ISO standards, not a diagnostic study requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

Not applicable. This was non-clinical material testing.

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

Not applicable. This applies to diagnostic devices, not dental cements.

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

Not applicable. This applies to diagnostic algorithms, not dental cements.

7. The Type of Ground Truth Used

The "ground truth" (or reference standard) was defined by the methodologies and reference materials/procedures specified in the international standards ISO 4049:2019 (Dentistry — Polymer-based restorative materials) and ISO 29022:2013 (Dentistry — Adhesion — Notched-edge shear bond strength test). This involves standardized laboratory measurements of material properties.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/ML device or a clinical study requiring training data.

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

Not applicable, as there is no training set mentioned or implied.

Summary

FDA 510(k) Clearance Letter - Choice 2 DC Dental Cement

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

July 11, 2025

Bisco, Inc
Jessica Bernstein
Global Regulatory Affairs Manager
1100 West Irving Park Road
Schaumburg, Illinois 60193

Re: K250156
Trade/Device Name: Choice 2 DC
Regulation Number: 21 CFR 872.3275
Regulation Name: Dental Cement
Regulatory Class: Class II
Product Code: EMA
Dated: March 21, 2025
Received: January 25, 2025

Dear Jessica Bernstein:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

Page 2

July 11, 2025

Bisco, Inc
Jessica Bernstein
Global Regulatory Affairs Manager
1100 West Irving Park Road
Schaumburg, Illinois 60193

Dear Jessica Bernstein:

K250156 - Jessica Bernstein Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).

Page 3

K250156 - Jessica Bernstein Page 3

Sincerely,

Bobak Shirmohammadi -S

Michael E. Adjodha, M.ChE., RAC, CQIA
Assistant Director
DHT1B: Division of Dental and ENT Devices
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Indications for Use

Submission Number (if known)
K250156

Device Name
Choice 2 DC

Indications for Use (Describe)

Choice 2 DC is a dual-cured, resin luting/veneering cement. The indications for use are to cement:

Indirect restorations (i.e. crowns, fixed prostheses (bridges), inlay, onlays
Endodontic posts
Cement-retained implant restorations/abutments (i.e. screws and crowns)
Veneers

Type of Use (Select one or both, as applicable)

☒ 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."

Page 5

510(k)#: K250156

510(k) Summary

Prepared on: 2025-07-10

Contact Details

21 CFR 807.92(a)(1)

Field	Value
Applicant Name	Bisco, Inc
Applicant Address	1100 West Irving Park Road Schaumburg IL 60193 United States
Applicant Contact Telephone	847-534-6034
Applicant Contact	Ms. Jessica Bernstein
Applicant Contact Email	jbernstein@bisco.com

Device Name

21 CFR 807.92(a)(2)

Field	Value
Device Trade Name	Choice 2 DC
Common Name	Dental cement
Classification Name	Cement, Dental
Regulation Number	872.3275
Product Code(s)	EMA

Legally Marketed Predicate Devices

21 CFR 807.92(a)(3)

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K101787	Duo-Link Universal (cleared as DUOLINK II)	EMA

Device Description Summary

21 CFR 807.92(a)(4)

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

Choice 2 DC is a dual-cured, resin luting/veneering cement. The indications for use are to cement:

Indirect restorations (i.e. crowns, fixed prostheses (bridges), inlay, onlays
Endodontic posts
Cement-retained implant restorations/abutments (i.e. screws and crowns)
Veneers

Indications for Use Comparison

21 CFR 807.92(a)(5)

The indications for use of Choice 2 DC are the similar to those for the predicate and reference devices. Minor differences in the indications for use do not change the intended use.

Technological Comparison

21 CFR 807.92(a)(6)

Choice 2 DC has similar technological characteristics to the predicate device, Duo-Link Universal (K101787), and the reference device, Variolink Esthetic DC (K142389). All components of Choice 2 DC are based upon industry standard chemistry. The chemical composition of Choice 2 DC is similar to the predicate and reference devices. All three devices are dual-cured, paste / paste form, and radiopaque. All

Page 6

three require the use of a dental adhesive and are available in a dual-syringe. The reference device is included due to the similar self-cure initiator system incorporated into the subject device.

Non-Clinical and/or Clinical Tests Summary & Conclusions

21 CFR 807.92(b)

Choice 2 DC, the predicate device, and the reference device were tested according to ISO 4049:2019. The tests conducted from ISO 4049:2019 were film thickness, working time, setting time, flexural strength, water sorption, water solubility, shade/color stability, and radiopacity. Additionally shear bond strength testing per ISO 29022:2013 was also conducted.

Biological safety of Choice 2 DC was assessed using ISO 7405:2018 and ISO 10993-1:2018 and found to be biocompatible.

Clinical testing is Not Applicable.

The nonclinical testing showed Choice 2 DC performed at least equal to the predicate and reference devices. In addition, Choice 2 DC met the requirements set forth in ISO 4049:2019. These results demonstrate that Choice 2 DC is as safe, as effective, and performs at least as well as the predicate and reference devices.

Regulation Number and Section

§ 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.