Choice 2 DC

K250156 · Bisco, Inc. · EMA · Jul 11, 2025 · Dental

Device Facts

• Record ID: K250156
• Device Name: Choice 2 DC
• Applicant: Bisco, Inc.
• Product Code: EMA · Dental
• Decision Date: Jul 11, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Choice 2 DC is a dual-cured, resin luting/veneering cement. The indications for use are to cement: 1. Indirect restorations (i.e. crowns, fixed prostheses (bridges), inlay, onlays 2. Endodontic posts 3. Cement-retained implant restorations/abutments (i.e. screws and crowns) 4. Veneers

Device Story

Choice 2 DC is a color-stable, dual-cured resin luting/veneering cement; used by dental professionals in clinical settings for permanent cementation of indirect restorations (glass ceramic, lithium disilicate, porcelain, composite, metal, or zirconia), endodontic posts, and implant-retained restorations. Device supplied in dual-syringe format; requires application of dental adhesive. Dual-cure mechanism allows for both light-curing and self-curing, ensuring polymerization in areas with limited light access. Provides radiopacity for radiographic identification. Clinical benefit includes secure, durable fixation of dental prosthetics, improving restoration longevity and patient oral function.

Clinical Evidence

No clinical data. Bench testing performed per ISO 4049:2019 (film thickness, working/setting time, flexural strength, water sorption/solubility, shade stability, radiopacity) and ISO 29022:2013 (shear bond strength). Biocompatibility assessed per ISO 7405:2018 and ISO 10993-1:2018. Results confirm Choice 2 DC performs at least equal to predicate and reference devices.

Technological Characteristics

Dual-cured resin cement; paste/paste formulation; radiopaque. Delivered via dual-syringe. Requires dental adhesive. Chemistry based on industry standards. Tested per ISO 4049:2019 and ISO 29022:2013.

Indications for Use

Indicated for cementation of indirect restorations (crowns, bridges, inlays, onlays), endodontic posts, cement-retained implant restorations/abutments, and veneers in patients requiring dental restorative procedures.

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

• Duo-Link Universal (K101787)

Reference Devices

• Variolink Esthetic DC (K142389)

Submission Summary (Full Text)

{0}

FDA U.S. FOOD & DRUG ADMINISTRATION

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"

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

{1}

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 ([e-mail]) or phone [phone] or 301-796-7100).

{2}

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

{3}

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

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:
1. Indirect restorations (i.e. crowns, fixed prostheses (bridges), inlay, onlays
2. Endodontic posts
3. Cement-retained implant restorations/abutments (i.e. screws and crowns)
4. 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
[e-mail]

"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."

{4}

| 510(k) #: K250156 | 510(k) Summary | Prepared on: 2025-07-10 |
| --- | --- | --- |
| Contact Details | | 21 CFR 807.92(a)(1) |
| 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 | [e-mail] | |
| Device Name | | 21 CFR 807.92(a)(2) |
| 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) |
| 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. | | |
| 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: 1. Indirect restorations (i.e. crowns, fixed prostheses (bridges), inlay, onlays 2. Endodontic posts 3. Cement-retained implant restorations/abutments (i.e. screws and crowns) 4. 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 | | |

{5}

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.