ESTELITE FLOW QUICK

K051808 · Tokuyama Dental Corporation · EBF · Aug 8, 2005 · Dental

Device Facts

• Record ID: K051808
• Device Name: ESTELITE FLOW QUICK
• Applicant: Tokuyama Dental Corporation
• Product Code: EBF · Dental
• Decision Date: Aug 8, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ESTELITE FLOW QUICK is a low viscous, light cured hybrid composite dental tooth shade resin material. It is intended for use in various dental procedures, including direct anterior and posterior restorations (particularly for small/shallow/tunnel shaped cavities), as the first layer of direct restorations, blocking out cavity undercuts before fabricating indirect restorations, and repair of porcelain/composite materials.

Device Story

ESTELITE FLOW QUICK is a low-viscosity, light-cured hybrid composite resin used by dental professionals for restorative procedures. It is applied directly into small, shallow, or tunnel-shaped cavities, used as a base layer for restorations, or utilized to block out undercuts prior to indirect restoration fabrication. It also serves as a repair material for existing porcelain or composite restorations. The device is cured using a dental light source. By providing a flowable, light-curable material, it allows clinicians to efficiently fill and repair dental structures, potentially improving procedural speed and restoration outcomes.

Clinical Evidence

No clinical data provided; substantial equivalence is based on chemical formulation comparison and performance characteristics.

Technological Characteristics

Low-viscosity, light-cured hybrid composite dental resin. Chemical composition is nearly identical to predicate with minor modifications to reduce curing time. Form factor is a flowable resin material.

Indications for Use

Indicated for use as a tooth shade resin material in dental procedures for direct anterior and posterior restorations, as a first layer for direct restorations, for blocking out cavity undercuts, and for repair of porcelain or composite materials.

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

• PALFIQUE ESTELITE LV (K002863)

Submission Summary (Full Text)

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# AUG 8 - 2005

<051808

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

#### Name of Device

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

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

#### Preparation Date

May 5, 2005

#### 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 FLOW QUICK is a low viscous, light cured hybrid composite dental tooth shade resin material. It is intended for use in various dental procedures, including direct anterior and posterior restorations (particularly for small/shallow/tunnel shaped cavities), as the first layer of direct restorations, blocking out cavity undercuts before fabricating indirect restorations, and repair of porcelain/composite materials.

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## Technological Characteristics and Substantial Equivalence

The chemical structure of ESTELITE FLOW QUICK is nearly identical to that of Tokuyama's own PALFIQUE ESTELITE LV (K#002863). The only change is a slight modification to the formula by adding three new chemicals, each of which comprising more than 0.1% of the total ingredients, which results in a reduction in the curing time of the device.

The ESTELITE FLOW QUICK is substantially equivalent to Tokuyama's own PALFIQUE ESTELITE LV (K#002863) for purposes of FDA market authorization. Although the ESTELITE FLOW QUICK has a slightly different chemical formulation resulting in improved performance, these differences do not raise new questions of safety or effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 8 - 2005

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

Re: K051808

Trade/Device Name: Estelite Flow Quick Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: June 30, 2005 Received: July 08, 2005

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 substant to market the device
referenced above and have determined the device is substantially equivalent for the indicatio use stated in the enclosure) to legally marketed predicate devices market in interstate on the indications for
prior to May 28, 1976, the enactment adte of the Madios Davices prior to May 28, 1976, the enactment date of the Medical Device American of the have been reclassified in accordance with the provisions of the Federal Front of the Personal Production
Act (Act) that do not require approval of a premarka organizat provis Act (Act) that do not require with the provisions of the Federal Food, Drug, and Cosm
Act (Act) that do not require approval of a premarket approval application (PMA). You m therefore, market the device, subject to the general controls provisions (PMA). You may,
therefore, market the device, subject to the general controls provisions of the Act. controls provisions of the Act include requirements for annual registration, listing of the peners
controls provisions of the Act include requirements for annual registration 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 culture, it
found in the Code of Federal Regulations Title 21, 2004 - 000 found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In additions and and the Code of Feriend of Feriend of Feriends, and further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Keith A. Barritt, Esq.

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 (Sections 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" (21 CFR 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.

Jennie Y. Michael Oms.

Chiu S. Lin, PhD 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

ા ૭ રાષ્ટ્રવૃત્ત

510(k) Number (if known):

Device Name: ESTELITE FLOW QUICK .

Indications For Use:

For use as a tooth shade resin material in dental procedures

AND/OR Over-The-Counter Use Prescription Use ਮ (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

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

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510(k) Number: K051808