JUELL SOFT CURE

K111178 · Juell Dental · EBI · Sep 12, 2011 · Dental

Device Facts

• Record ID: K111178
• Device Name: JUELL SOFT CURE
• Applicant: Juell Dental
• Product Code: EBI · Dental
• Decision Date: Sep 12, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

JUELLCure Soft is indicated for use as a permanent soft relining for total and partial dentures: . - to relieve pressure from pressure points - - to dam the palatal vibrating line - - in cases of flabby ridge and/or insufficient adhesion - - to cushion sharp-edged alveolar processes

Device Story

JuellCure Soft is a self-curing, silicone-based, permanently soft relining material for removable dentures. It is applied by dental professionals in a clinical setting to improve denture fit and patient comfort. The material functions by providing a cushioning layer between the denture base and the oral mucosa, effectively relieving pressure from sensitive areas such as sharp-edged alveolar processes or flabby ridges, and assisting in sealing the palatal vibrating line. The device is supplied as a multi-component system (base, catalyst, glazing components) that is mixed and applied to the denture. The resulting material provides a stable, soft interface that improves denture adhesion and reduces patient discomfort. No complex electronic or software components are involved.

Clinical Evidence

Bench testing only. Performance was evaluated through comparative laboratory testing of physical properties, including surface hardness (Shore A), adhesion to dentures, and working/setting times. Results showed identical performance metrics between JuellCure Soft and the predicate device.

Technological Characteristics

Silicone-based, self-curing resin for denture relining. Composition includes monomer matrix (70-90%), rheologic modifiers (10-30%), catalysts (0.1-0.5%), stabilizers, and co-monomers. Physical properties: Shore A hardness 26.3, adhesion 190 N, working time 201 s. Non-electronic, non-software device.

Indications for Use

Indicated for patients requiring permanent soft relining for total or partial dentures to address pressure points, palatal vibrating line damming, flabby ridges, insufficient adhesion, or sharp-edged alveolar processes.

Regulatory Classification

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.

Predicate Devices

• Ufi Gel SC (K974772)

Submission Summary (Full Text)

{0}------------------------------------------------

KIII78

#### 510k Summary

SEP 1 2 2011 July 13, 2011

#### Trade Name: JUELLCure Soft

Common Name: soft impression material

Company Contact:

John Roderick, Operations Manager Juell Dental 2401 N. Commerce Ardmore, OK 73401 [phone]

Device Classification: resin, denture, relining, rebasing

Device CFR Section: 21 CFR 872.3760

FDA Device Class: Class II

FDA Product Code: EBI

Classification Panel: Dental

Device Description: JuellCure Soft is a self-curing, silicone-based and permanently soft relining material for removable dentures.

#### Indications for Use:

JUELL Soft Cure is intended for use as a permanent soft relining for total and partial dentures

- . To relieve pressure from pressure points
- To dam the palatal vibrating line ●
- . In cases of flabby ridge and/or insufficient adhesion
- . To cushion sharp-edged alveolar processes

#### Testing

The working time and setting time were determined for the Soft Cure base, catalyst, glazing base, and glazing catalyst. The surface hardness (Shor hardness A), and adhesion to dentures was determined.

Predicate Device: Ufi Gel SC, K974772, VOCO GmbH, Germany

{1}------------------------------------------------

511178

### Substantial Equivalence

The material composition of Ufi Gel SC and Juel Soft Cure are very similar. The indications for use are the same. The surface hardness, adhesion time and working time are the same.

| Function | JUELL Soft Cure | Ufi Gel SC |
|--------------------|-----------------|------------|
| Monomer Matrix | 70-80 % | 70-80 % |
| Rheologic Modifier | 15-30 % | 15-30 % |
| Catalyst | 0,1-0,5 % | 0,1-0,5 % |
| Monomer Matrix | 70-80 % | 70-80 % |
| Rheologic Modifier | 15-30 % | 15-30 % |
| Colorant | <0.1 % | <0.1 % |
| Co-Monomer | 5-10 % | 5-10 % |

| Function | JUELL Soft Cure | Ufi Gel SC |
|--------------------|-----------------|-------------|
| Monomer Matrix | 80 - 90 % | 80 - 90 % |
| Rheologic Modifier | 10 - 20 % | 10 - 20 % |
| Catalyst | 0,1 - 0,5 % | 0,1 - 0,5 % |
| Monomer Matrix | 60 - 70 % | 60 - 70 % |
| Rheologic Modifier | 20 - 30 % | 20 - 30 % |
| Stablizer | 8 - 15 % | 8 - 15 % |

| Function | JUELL Soft Cure | Ufi Gel SC |
|----------------|-----------------|------------|
| Monomer Matrix | 70 - 85 % | 70 - 85 % |

{2}------------------------------------------------

| | | 8<br>- |
|---|--------|--------|
| | r<br>- | - |
| f | -<br>/ | |
| 1 | | |

| Rheologic Modifier | 15-20 % | 15-20 % |
|--------------------|-------------|-------------|
| Stabilizer | 0,1 - 0,5 % | 0,1 - 0,5 % |
| Co-Monomer | 2-5% | 2-5% |

| Test Item | JUELL Soft Cure | Ufi Gel SC |
|----------------------------------------|-----------------|------------|
| Surface hardness<br>(Shore hardness A) | 26.3 | 26.3 |
| Adhesion to dentures | 190 N | 190 N |
| Working time | 201 s | 201 s |

24.25

JuellCure Soft is substantially equivalent to Ufi Gel SC in regards to indications, composition, and testing results.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle around the eagle. The eagle is facing to the right. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Juell Dental C/O Ms. Angela Blackwell Senior Consultant Biologies Consulting Group 2401 N Commerce Ardmore, Oklahoma 73401

SEP 12 2011

Re: K111178

Trade/Device Name: JuellCure Soft Impression Material Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining. Repairing. or Rebasing Resin Regulatory Class: II 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 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. 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 (OS) 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 (CDRHis) 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 [phone] or [phone] 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}------------------------------------------------

# Indications for Use

510(k) Number (if known): _K111178

Device Name: JuellCure Soft Impression Material

Indications for Use:

JUELLCure Soft is indicated for use as a permanent soft relining for total and partial dentures: .

- to relieve pressure from pressure points -
- to dam the palatal vibrating line -
- in cases of flabby ridge and/or insufficient adhesion -
- to cushion sharp-edged alveolar processes

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 Puma

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

Page of

510(k) Number: K111178