1. All indirect restorations (ie. crowns, bridges, inlay, and onlays fabricated from metal composite, porcelain, ceramic, zirconia, alumina, etc)
1. All endodontic posts (ie. fiber, composite, and metal)
1. All abutments (ie. screws)

Device Description

DuoLink II is a dual-cured, radio-apparent composite luting cement.

AI/ML Overview

This document describes the DuoLink II Composite Luting Cement, a dental device cleared by the FDA. The submission for this device is a 510(k) premarket notification, which demonstrates substantial equivalence to legally marketed predicate devices rather than proving independent safety and efficacy through a standalone study with defined acceptance criteria and performance metrics.

Therefore, the requested information regarding acceptance criteria, specific study details (sample sizes, expert ground truth, adjudication, MRMC, standalone performance), and training set information is generally not applicable in the context of a 510(k) submission for a device like DuoLink II.

A 510(k) submission primarily focuses on comparing the new device's technological characteristics and performance data to established predicate devices to claim substantial equivalence.

Here's an adaptation of the requested table and explanation based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: For a 510(k) submission, "acceptance criteria" are typically met by demonstrating that the new device performs "as well as or better than" its predicate devices, rather than meeting specific numerical thresholds set independently. The "reported device performance" in this context refers to the comparative data presented.

Performance Metric / Characteristic	Acceptance Criteria (Met by demonstrating equivalence/superiority to predicate)	Reported Device Performance (DuoLink II)	Evidence Source
Chemical Composition	Must be based on industry standard monomer chemistry and be equivalent to predicate DuoLink (K934596).	Based upon industry standard monomer chemistry; shares key chemical characteristics (Self-Cure, Light-Cure, Glass Filled, Methacrylate resin based) with predicate DuoLink (K934596) and Calibra (K040906).	Chemical Composition table (Page 1)
Physical/Mechanical Properties	Must perform "as well as or better than" predicate Calibra (K040906), per ISO 4049:2009.	Medium viscosity dispensable material, Radio-apparent. Explicitly states: "DuoLink II is performs as well as or better than Calibra."	Performance Data section and table (Page 1), ISO 4049:2009
Biocompatibility	Must meet FDA guidelines and ISO 10993-1, showing no evidence of cell lysis or toxicity.	No evidence of causing any cell lysis or toxicity; met requirements of the test. Concluded safe for intended use.	Biocompatibility section (Page 1)
Indications for Use	Must be consistent with legally marketed predicate devices.	Cementing all indirect restorations (crowns, bridges, inlays, onlays), all endodontic posts, and all abutments.	Indications for Use section (Page 0, Page 5)

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

Sample Size for Test Set: Not specified. The document refers to "testing" for physical/mechanical properties and biocompatibility, but the sample sizes for these tests are not provided.
Data Provenance: The studies appear to be laboratory-based tests conducted to evaluate chemical, physical/mechanical, and biocompatibility aspects. The country of origin and whether they are retrospective or prospective are not detailed. These are likely internal or contract lab studies performed for the submission.

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

Not Applicable. For a 510(k) submission for a dental cement, ground truth in the sense of expert consensus on clinical outcomes or diagnoses is usually not established. The "ground truth" for the performance data derives from standardized laboratory tests (e.g., ISO standards) and material science principles.

4. Adjudication Method for the Test Set

Not Applicable. As the "test set" primarily refers to laboratory measurements, there is no expert adjudication method like 2+1 or 3+1 typically used for clinical endpoints or diagnostic accuracy.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study was not conducted as this is a dental cement, not a diagnostic imaging device. The "comparative effectiveness" is established through laboratory performance comparisons with predicate devices, not human reader performance.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

Not Applicable. This device is a material (dental cement), not an algorithm or AI system. Its performance is inherent to its physical, chemical, and biological properties, not a computational output.

7. Type of Ground Truth Used

The "ground truth" for demonstrating substantial equivalence relies on:
- Standardized Laboratory Testing: Adherence to standards like ISO 4049:2009 for physical/mechanical properties and ISO 10993-1 for biocompatibility.
- Chemical Analysis: Comparison of chemical composition to established, legally marketed predicate devices.
- Predicate Device Performance: The established performance and safety profile of the predicate devices (DuoLink K934596, Calibra K040906, Self-Adhesive Luting Cement K093338) serve as the benchmark for the new device.

8. Sample Size for the Training Set

Not Applicable. This is a material device; there is no "training set" in the context of machine learning. The term "training set" is not relevant here.

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

Not Applicable. As there is no training set, this question is not relevant.

Summary Explanation:

The provided document is a 510(k) summary for a dental cement. The purpose of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, not to prove de novo safety and effectiveness through extensive clinical trials with specific acceptance criteria as you might find for novel high-risk medical devices or AI/ML-based diagnostics.

The "study" in this context comprises various laboratory tests (chemical composition analysis, physical/mechanical property evaluation including ISO 4049:2009, and biocompatibility testing per ISO 10993-1) which are designed to show that DuoLink II functions similarly to and is as safe and effective as its predicate devices. The "acceptance criteria" are implicitly met by showing that the new device is "as well as or better than" the predicate devices in these measured aspects. The FDA's clearance (K101787) indicates that this substantial equivalence was successfully demonstrated.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for BISCO, a dental company. The logo is made up of six hexagons, each containing a letter that spells out the company's name. Below the logo is the tagline "Bringing Science to the Art of Dentistry." There is also a handwritten number "K10178" in the upper right corner of the image.

OCT 8 2010

510 (k) SUMMARY (per 21 CFR 807.92)

Applicant:

Contact Person:

Date Prepared: Trade Name: Common Name: Product Code: Classification/Name:

Bisco, Inc. 1100 W. Irving Park Road Schaumburg IL, 60193 Michelle Schiltz-Taing Tel: 847-534-6146 Fax: 847-534-6111 September 22, 2010 DuoLink II Composite Luting Cement EMA Dental Cement Class II per 21 CFR 872.3275

Predicate Devices:

Duolink by Bisco, Inc., Schaumburg IL K934596 Calibra by Dentsply Intl., York PA K040906 Self-Adhesive Luting Cement by DMG USA Inc., Ayer MA K093338

Description of the Applicant Device/Indications for use:

DuoLink II is a dual-cured, radio-apparent composite luting cement.

The indications of use of DuoLink II are to cement:

1. All indirect restorations (ie. crowns, bridges, inlay, and onlays fabricated from metal composite, porcelain, ceramic, zirconia, alumina, etc)
All endodontic posts (ie. fiber, composite, and metal) 2.
1. All abutments (ie. screws)

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

An ISO 13485 Certified Company

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Image /page/1/Picture/0 description: The image shows the logo for BISCO, a dental company. The logo consists of the letters "BISCO" arranged in a hexagonal pattern. Below the logo is the tagline "Bringing Science to the Art of Dentistry".

510 (k) SUMMARY (continued)

Technological Characteristics

All chemical components of DuoLink II are based upon industry standard monomer chemistry and are found in the legally marketed predicate device DuoLink (K934596). A comparison of the technological characteristics to the predicate devices is summarized below.

Chemical Composition	DuoLinkK934596	Calibra(K040906)	Self AdhesiveLuting CementK093338	DuoLink II
Self-Cure	X	X	X	X
Light-Cure	X	X	X	X
Glass Filled	X	X	X	X
Methacrylate resin based	X	X	X	X
Self-Adhesive			X

Performance Data

Physical/mechanical properties of Duo-Link II were tested using ISO 4049:2009. The Information provided in this 510(k) of DuoLink II as compared to Calibra (K040906) demonstrates that DuoLink II is performs as well as or better than Calibra. A comparison of the physical/mechanical properties is included in the chart below:

Physical / Mechanical PropertyComparison	DuoLinkK934596	Calibra(K040906)	DuoLink II
Medium viscosity dispensablematerial	X	X	X
Radio-apparent	X	X	X

Biocompatibility

Biocompatibility testing was conducted to determine the safety of the DuoLink II using FDA guidelines and ISO 10993-1. Cytotoxicity using the ISO Agarose Overlay Method determined t hat the samples showed no evidence of causing any cell lysis or toxicity and met the requirements of the test. The conclusion of the safety evaluation and subsequent cytotoxicity testing is that DuoLink II is safe for its intended use.

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/2/Picture/0 description: The image shows the logo for BISCO, a dental company. The logo consists of the letters "BISCO" arranged in a hexagonal pattern. Below the logo is the tagline "Bringing Science to the Art of Dentistry."

510 (k) SUMMARY (continued)

Conclusion

Side by side comparisons clearly demonstrate that the applicant device is substantially equivalent to other the legally marketed devices: Duolink (K934596), Calibra (K040906), and Self Adhesive Composite Luting Cement (K093338). It is concluded that the information, formulation, physical properties, and biocompatibility, supplied in this submission has proven the safety and efficacy of this product.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the department's name encircling a stylized emblem. The emblem consists of a symbol with three curved lines, resembling a stylized representation of a human form or a flame.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

Ms. Michelle Schiltz-Taing Regulatory Affairs Coordinator Bisco, Incorporated 1100 West Irving Park Road Schaumberg, Illinois 60193

OCT 82010

Re: K101787

Trade/Device Name: DuoLink II Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: September 28, 2010 Received: September 29, 2010

Dear Ms. Schiltz-Taing:

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.

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Page 2- Ms. Schiltz-Taing

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 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510 (k) Number (if known):

Device Name:

Indications for Use:

DuoLink II is a dual-cured, radio-apparent composite luting cernent.

The indications of use of DuoLink II are to cement:

1. All indirect restorations (ie. crowns, bridges, inlay, and onlays fabricated from metal composite, porcelain, ceramic, zirconia, alumina, etc)
  101
1. All endodontic posts (ie. fiber, composite, and metal)
1. All abutments (ie. screws)

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suza Rupar

(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division Control, Dental Devices

510(k) Number: K1016

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.