SOFRELINER TOUGH S

K112445 · Tokuyama Dental Corporation · EBI · Oct 28, 2011 · Dental

Device Facts

• Record ID: K112445
• Device Name: SOFRELINER TOUGH S
• Applicant: Tokuyama Dental Corporation
• Product Code: EBI · Dental
• Decision Date: Oct 28, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SOFRELINER TOUGH S denture relining, repairing, or rebasing resin device is for use as a denture reliner.

Device Story

SOFRELINER TOUGH S is a prescription addition-cured silicone chairside soft lining material for removable dentures. It consists of a base and catalyst paste, a primer for bonding to acrylic surfaces, and various accessories (spatula, brush, mixing tip, finishing tools). Used by dental professionals in a clinical setting to reline, repair, or rebase dentures. The material is applied to the denture surface to improve fit and patient comfort. It does not require sterilization. Safety is established through biocompatibility testing and physical property evaluation.

Clinical Evidence

No clinical data. Evidence consists of non-clinical bench testing of physical properties (depth of penetration, consistency, working/setting time) conducted in accordance with ISO 10139-1:1991 and ISO 10139-2:1999, alongside biocompatibility testing.

Technological Characteristics

Addition-cured silicone resin material. Components: base/catalyst paste, primer. No energy source. Non-sterile. Physical properties tested per ISO 10139-1:1991 and ISO 10139-2:1999.

Indications for Use

Indicated for use as a denture reliner for patients requiring soft lining of removable dentures.

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

• TOKUYAMA SOFRELINER (K982537)
• TOKUYAMA SOFRELINER TOUGH (K030663)
• GC RELINE ULTRA SOFT (K990736)

Submission Summary (Full Text)

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12112445

# 510(k) Summary Tokuyama Dental Corporation SOFRELINER TOUGH S Denture Relining, Repairing, Or Rebasing Resin Device

The following information is provided pursuant to 21 CFR 807.92.

## 807.92(a)(1)

## (i) 510(k) Submitter

Tokuyama Dental Corporation 38-9 Taitou 1-chome, Taitou-ku Tokyo 110-0016 Japan Phone: [phone]

# (ii) 510(k) Submitter Contact

Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W., Suite 1100 Washington, DC 20005 Phone: [phone] Facsimile: [phone] Email: barritt(@fr.com

## (iii) Preparation Date

August 3, 2011

# 807.92(a)(2)

| Trade or Proprietary Name: | SOFRELINER TOUGH S |
|----------------------------|---------------------------------------------------------|
| Common Name: | denture relining, repairing, or rebasing resin material |
| Classification Name: | resin, denture, relining, repairing, rebasing |
| Product Code: | EBI |

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#### 807.92(a)(3)

The SOFRELINER TOUGH S device is substantially equivalent for purposes of FDA medical device regulations to multiple predicate devices, namely Tokuyama's own TOKUYAMA SOFRELINER (K#982537), TOKUYAMA SOFRELINER TOUGH (K#030663), and GC America's GC RELINE ULTRA SOFT (K#990736).

## 807.92(a)(4)

The SOFRELINER TOUGH S denture relining, repairing, or rebasing resin device is a prescription addition-cured silicone chairside soft lining material for removable dentures. It is indicated for use as a denture reliner.

The main components of the SOFRELINER TOUGH S device are:

- 1) A paste consisting of a base and catalyst;
- A primer packaged separate used for bonding to the acrylic surfaces; and 2)
- Various accessories, namely a spatula, brush, drip-cap, drip-cup, mixing 3) tip, coarse point, finish wheel, and washer

Nearly all ingredients used in the SOFRELINER TOUGH S denture relining, repairing, or rebasing device are either commonly used in similar dental devices or have been subjected to extensive biocompatibility testing. However, the paste of the SOFRELINER TOUGH S does contain one new ingredient and thus toxicity testing was performed, namely cytotoxicity, sensitization, irritation, subchronic systemic toxicity, and genotoxicity.

The SOFRELINER TOUGH S denture relining, repairing, or rebasing resin device does not come sterilized and is not intended to be sterilized prior to use.

#### 807.92(a)(5)

The SOFRELINER TOUGH S denture relining, repairing, or rebasing resin device is for use as a denture reliner.

#### 807.92(a)(6)

The SOFRELINER TOUGH S device has the same basic technological characteristics in terms of design, material, and chemical composition as the predicate devices identified above. The SOFRELINER TOUGH S device does not have an energy source.

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Specifically, for purposes of design the device has the same basic design and performance characteristics as Tokuyama's own TOKUYAMA SOFRELINER (K#982537). TOKUYAMA SOFRELINER TOUGH (K#030663), and GC America's GC RELINE ULTRA SOFT (K#990736). For purposes of material composition, the device has the same basic properties as TOKUYAMA SOFRELINER TOUGH.

# 807.92(b)(1)

Non-clinical testing of the physical properties of the SOFRELINER TOUGH S device, including depth of penetration, difference between mean depth of penetration at 24 hours and 28 days, depth of penetration ratio "R", consistency, 2 hour penetration, 7 day penetration, and penetration ratio were conducted in accordance with ISO 10139-1: 1991 and ISO 10139-2: 1999. Other testing included appearance, working time, and setting time.

#### 807.92(b)(2)

There were no clinical tests performed for the SOFRELINER TOUGH S device.

#### 807.92(b)(3)

Based on the non-clinical testing conducted of the physical properties of the SOFRELINER TOUGH S device and the material composition review in comparison to the predicate devices and biocompatibility testing as described above, it is concluded that the SOFRELINER TOUGH S device is as safe, as effective, and performs as well as or better than the predicate devices.

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Image /page/3/Picture/0 description: The image contains a partial view of a logo on the left and the word "DEPARTMENT" on the right. The logo includes the words "HUMAN SERVICES - USA" arranged in a circular pattern around a stylized graphic. Below the word "DEPARTMENT" is a horizontal line.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

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

OCT 2 8 2011

Tokuyama Dental Corporation C/O Mr. Keith A. Barritt, Esq. Fish & Richardson P.C. 1425 K Street, N.W., Suite 1100 Washington, DC 20005

Re: K112445

Trade/Device Name: Sofreliner Tough S Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Codes: EBI Dated: August 12, 2011 Received: August 24, 2011

Dear Mr. Barritt:

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 - Mr. Barritt

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

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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Indications for Use

K112445 510(k) Number (if known): uńknown

Device Name: SOFRELINER TOUGH S

Indications for Use:

The SOFRELINER TOUGH S denture relining, repairing, or rebasing resin device is for use as a denture reliner.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Kumar

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

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510(k) Number: K112445

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