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.

Device Description

JuellCure hard is a cold-curing, hard relining material for permanently relining dentures.

AI/ML Overview

The provided text describes the 510(k) summary for the JuellCure Hard, a hard impression material for relining dentures. The submission aims to demonstrate substantial equivalence to a predicate device, Ufi Gel Hard C (K030916).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Predicate Device K030916)	Reported Device Performance (JuellCure Hard)
Setting Time	135-180 seconds	135-180 seconds
Appearance	Paste is a colorless, homogenous liquid and the catalyst is a white homogenous paste.	Paste is a colorless, homogenous liquid and the catalyst is a white homogenous paste.
Composition of Catalyst	Matrix 40-60%, Filler 30-40%, Catalyst 2-4%, Modifier 6-7%, Stabilizer <0.1%	Matrix 40-60%, Filler 30-40%, Catalyst 2-4%, Modifier 6-7%, Stabilizer <0.1%
Composition of Paste	Monomer: HEDMA, UDMA, Bis-GMA 30-50%, Filler 40-60%, Colorant <0.1%, Modifier 5-6%, Stabilizer <0.1%	Monomer: HEDMA, UDMA, Bis-GMA 30-50%, Filler 40-60%, Colorant <0.1%, Modifier 5-6%, Stabilizer <0.1%
Flexural Strength	78 Mpa	78 Mpa
Translucency of 2mm specimens	44%	44%
Adhesion to denture material	Implied to be similar to predicate	Implied to be similar to predicate
Thermocycling	Implied to be similar to predicate	Implied to be similar to predicate
Color stability	Implied to be similar to predicate	Implied to be similar to predicate
Heat of polymerization	Implied to be similar to predicate	Implied to be similar to predicate

Note: For "Adhesion to denture material," "Thermocycling," "Color stability," and "Heat of polymerization," the document states: "The values for these performance characteristics was found to be very similar to the predicate device." While specific numerical acceptance criteria are not explicitly given for these, the "very similar" statement implies the JuellCure Hard met an unstated acceptance threshold based on predicate performance.

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

The document does not specify the sample size used for performance testing (e.g., for flexural strength, translucency, etc.) nor does it explicitly mention data provenance (e.g., country of origin, retrospective or prospective). The testing appears to be laboratory-based evaluation of material properties, not clinical data from patients.

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

This information is not provided in the document. The performance testing described relates to the physical and chemical properties of the material, which would be measured in a lab setting, not typically evaluated by clinical experts in the same way, for example, diagnostic imaging studies would be.

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

The concept of an "adjudication method" (like 2+1 or 3+1 consensus) is primarily relevant for studies involving subjective human interpretation, such as medical image reading. For laboratory-based performance testing of a material, this method is not applicable and therefore not mentioned in the submission.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC study is relevant for evaluating the impact of AI on human reader performance in tasks like diagnostic interpretation. This submission is for a dental material (hard impression material), not an AI-powered diagnostic device. Therefore, an MRMC study was not conducted and is not applicable.

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

This is not an AI-powered device. Therefore, a standalone (algorithm-only) performance evaluation was not done and is not applicable.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance testing mentioned (e.g., flexural strength, setting time, translucency) would be established through standardized material testing methods and measurements. For instance, flexural strength would be measured using an appropriate mechanical testing machine, and setting time would be determined according to an established dental materials standard. The comparison is made against the reported performance of the predicate device.

8. The Sample Size for the Training Set

This question is relevant for machine learning or AI-based devices. The JuellCure Hard is a material, not an AI device, so there is no training set in this context.

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

As there is no training set, this question is not applicable.

Summary

{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 foruse as a permanent hard reliningfor total and partial dentureshard permanent total orpartial relining forrestoring partial- andcomplete dentureslengthening denturemargins	Ufi Gel Hard C is intended for useas a permanent hard relining fortotal and partial dentureshard permanent total orpartial relining forrestoring partial- andcomplete dentureslengthening denturemargins
Setting Time	135-180 seconds	135-180 seconds
Appearance	Paste is a colorless, homogenousliquid and the catalyst is a whitehomogenous paste.	Paste is a colorless, homogenousliquid and the catalyst is a whitehomogenous paste.
Composition of Catalyst	Matrix 40-60%Filler 30-40%Catalyst 2-4%Modifier 6-7%Stabilizer <0.1%	Matrix 40-60%Filler 30-40%Catalyst 2-4%Modifier 6-7%Stabilizer <0.1%
Composition of Paste	Monomer : HEDMA, UDMA, Bis-GMA 30-50%Filler 40-60%Colorant <0.1%Modifier 5-6%Stabilizer <0.1%	Monomer : HEDMA, UDMA, Bis-GMA 30-50%Filler 40-60%Colorant <0.1%Modifier 5-6%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

Regulation Number and Section

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.