ESTELITE SIGMA QUICK

K080940 · Tokuyama Dental Corporation · EBF · Jun 19, 2008 · Dental

Device Facts

• Record ID: K080940
• Device Name: ESTELITE SIGMA QUICK
• Applicant: Tokuyama Dental Corporation
• Product Code: EBF · Dental
• Decision Date: Jun 19, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ESTELITE SIGMA QUICK is is a light cured, radiopaque, submicron-filled composite resin for use in anterior and posterior restorations and is indicated for all carious classes.

Device Story

ESTELITE SIGMA QUICK is a light-cured, radiopaque, submicron-filled composite resin used by dental professionals for anterior and posterior restorations. It is applied to treat all carious classes. The device functions as a restorative material that hardens upon exposure to a dental curing light. It is designed to offer a shortened curing time compared to its predecessor. The material is intended for clinical use by dentists to restore tooth structure affected by decay, providing both functional and aesthetic benefits to the patient.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Light-cured, radiopaque, submicron-filled composite resin. Formulated for shortened curing time compared to predicate devices. Class II medical device.

Indications for Use

Indicated for use as a tooth shade resin in dental procedures for anterior and posterior restorations in all carious classes.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Predicate Devices

• ESTELITE SIGMA (K980051)
• ESTELITE FLOW QUICK (K051808)

Submission Summary (Full Text)

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KO 80940

## 510(k) SUMMARY Tokuyama Dental Corporation ESTELITE SIGMA QUICK

JUN 19 2008

#### Name of Device

Trade or Proprietary Name: Common Name: Classification Name: Product Code:

ESTELITE SIGMA QUICK tooth shade resin material material, tooth shade, resin EBF

#### Preparation Date

March 28, 2008

#### 510(k) Sponsor

Tokuyama Dental Corporation 38-9 Taitou 1-chome, Taitou-ku Tokyo 110-0016 Japan

### 510(k) Sponsor Contact

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

#### Intended Use

ESTELITE SIGMA QUICK is is a light cured, radiopaque, submicron-filled composite resin for use in anterior and posterior restorations and is indicated for all carious classes.

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## Technological Characteristics and Substantial Equivalence

The chemical structure of ESTELITE SIGMA QUICK is nearly identical to Tokuyama's own ESTELITE SIGMA (a modification of K#980051) and ESTELITE FLOW QUICK (K#051808). ESTELITE SIGMA QUICK is formulated to shorten the curing time of the resin material compared to ESTELITE SIGMA.

The ESTELITE SIGMA QUICK is substantially equivalent, for purposes of FDA market authorization, to Tokuyama's own ESTELITE SIGMA (K#980051 as modified) and ESTELITE FLOW QUICK (K#051808). Although the ESTELITE SIGMA QUICK has a slightly different chemical formulation than either product, these differences do not raise new questions of safety or effectiveness, as discussed below.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN 1 9 2008

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

Rc: K080940

Trade/Device Name: ESTELITE SIGMA QUICK Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: April 2, 2008 Received: April 4, 2008

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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 (Scctions 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Sutie y. Mickeonds

Chiu Lin, Ph.D. 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

510(k) Number (if known): K080940

Device Name: Estelite Sigma Quick

Indications for Use:

For use as a tooth shade resin in dental procedures.

Prescription Use X (21 CFR Part 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR Part 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suren Russo

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

510(k) Number:

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