JUELL HARD CURE

{0}------------------------------------------------ ### 510K Summary July 13, 2011 KIIII77 Trade Name : JUELLCure Hard SEP 1 2 2011 Common Name: Hard impression material Company Contact: John Roderick, Operations Manager Juell Dental 2401 N. Commerce Ardmore, OK 73401 (580) 798-4414 Classification Name - Resin, denture, relining, repairing, rebasing CFR Section: 872.3760 FDA Device Class: Class II FDA Product Code : EBI Classification Panel : Dental Device Description: JuellCure hard is a cold-curing, hard relining material for permanently relining dentures. #### Indications for Use: JUELL Hard Cure is intended for use as a permanent hard relining for total and partial dentures - . hard permanent total or partial relining for restoring partial- and complete dentures - � lengthening denture margins ## Performance Testing: Testing including adhesion to denture material, thermocycling, flexural strength, color stability, heat of polymerization, and translucency were conducted. The values for these performance characteristics was found to be very similar to the predicate device. Predicate Device: Ufi Gel hard C, K030916, VOCO GmbH, Germany {1}------------------------------------------------ Image /page/1/Picture/0 description: The image contains a series of symbols or characters that appear to be handwritten. The characters include what looks like a capital 'K', followed by four vertical lines, and then two symbols that resemble the number '7'. The writing is somewhat crude and lacks uniformity, suggesting it may be a quick or informal note. # Substantial Equivalence: | | Juell Hard Cure | Ufi Gel Hard C K030916 | |-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | JUELL Hard Cure is intended for<br>use as a permanent hard relining<br>for total and partial dentures<br>hard permanent total or<br>partial relining for<br>restoring partial- and<br>complete dentureslengthening denture<br>margins | Ufi Gel Hard C is intended for use<br>as a permanent hard relining for<br>total and partial dentures<br>hard permanent total or<br>partial relining for<br>restoring partial- and<br>complete dentureslengthening denture<br>margins | | Setting Time | 135-180 seconds | 135-180 seconds | | Appearance | Paste is a colorless, homogenous<br>liquid and the catalyst is a white<br>homogenous paste. | Paste is a colorless, homogenous<br>liquid and the catalyst is a white<br>homogenous paste. | | Composition of Catalyst | Matrix 40-60%<br>Filler 30-40%<br>Catalyst 2-4%<br>Modifier 6-7%<br>Stabilizer <0.1% | Matrix 40-60%<br>Filler 30-40%<br>Catalyst 2-4%<br>Modifier 6-7%<br>Stabilizer <0.1% | | Composition of Paste | Monomer : HEDMA, UDMA, Bis-<br>GMA 30-50%<br>Filler 40-60%<br>Colorant <0.1%<br>Modifier 5-6%<br>Stabilizer <0.1% | Monomer : HEDMA, UDMA, Bis-<br>GMA 30-50%<br>Filler 40-60%<br>Colorant <0.1%<br>Modifier 5-6%<br>Stabilizer <0.1% | | Flexural Strength | 78 Mpa | 78 Mpa | | Translucency of 2mm specimens | 44% | 44% | Juell Hard Cure is substantially equivalent to VOCO Ufi Gel Hard C in regards to composition, indications for use and performance characteristics. . . . . . {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized symbol that resembles an abstract representation of a human figure. The symbol consists of three curved lines that converge at the bottom, forming a shape that suggests a person with outstretched arms. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MI) 20993-0002 Juell Dental C/O Ms. Angela Blackwell Senior Consultant Biologies Consulting Group 2401 N Commerce Ardmore, Oklahoma 73401 SEP 1 2 2011 Re: K111177 Trade/Device Name: JuellCure Hard Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: 11 Product Code: EBI Dated: August 30, 2011 Received: September 1, 2011 Dear Ms. Blackwell: 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 111 (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. {3}------------------------------------------------ Page 2 - Ms. Blackwell 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/detault.htm for the CDRH² 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 vours. Wh 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 {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): K111177 Device Name: Indications for Use: ... · JuellCure Hard is intended for use as a permanent hard relining for total and partial dentures - . Hard permanent total or partial relining for restoring partial and complete dentures - Lengthening denture margins . Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Susan Pearson (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices Page __ of ___________________________________________________________________________________________________________________________________________________________________ 510(k) Number: K11177