(105 days)
No
The document describes a composite luting cement and its physical/mechanical properties and biocompatibility. There is no mention of AI or ML technology.
No
This device is a dental luting cement used for cementing various restorative materials and posts; it does not treat or prevent a disease or condition.
No
This device is described as a "composite luting cement" used for cementing restorations, endodontic posts, and abutments. Its function is to bond, not to diagnose.
No
The device description clearly states it is a "composite luting cement," which is a physical material, not software. The performance studies also focus on physical and biocompatibility properties.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that DuoLink II is a composite luting cement used for cementing various dental restorations and posts. This is a direct application within the body (or on structures that will be placed within the body), not for testing samples taken from the body to diagnose a condition.
- Device Description: The description reinforces that it's a luting cement, a material used for bonding.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. DuoLink II does not fit this description.
N/A
Intended Use / Indications for Use
DuoLink II is a dual-cured, radio-apparent composite luting cement.
The indications of use of DuoLink II are to cement:
-
- 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.
-
- All abutments (ie. screws)
Product codes
EMA
Device Description
DuoLink II is a dual-cured, radio-apparent composite luting cement.
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
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.
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.
Key Metrics
Not Found
Predicate Device(s)
Duolink K934596, Calibra K040906, Self-Adhesive Luting Cement K093338
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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:
-
- 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.
-
- 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
1
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 | DuoLink
K934596 | Calibra
(K040906) | Self Adhesive
Luting Cement
K093338 | 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 Property
Comparison | DuoLink
K934596 | Calibra
(K040906) | DuoLink II |
|----------------------------------------------|--------------------|----------------------|------------|
| Medium viscosity dispensable
material | 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
2
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
3
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.
4
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
5
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:
-
- All indirect restorations (ie. crowns, bridges, inlay, and onlays fabricated from metal composite, porcelain, ceramic, zirconia, alumina, etc)
101
- 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)
-
- 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