DYRACT EXTRA RESTORATIVE

K050880 · Dentsply Intl. · EBF · Apr 22, 2005 · Dental

Device Facts

• Record ID: K050880
• Device Name: DYRACT EXTRA RESTORATIVE
• Applicant: Dentsply Intl.
• Product Code: EBF · Dental
• Decision Date: Apr 22, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

DYRACT® EXTRA RESTORATIVE is indicated for Cavity Classes III, IV, V, and VI. Cavity Classes I and II where the cavity preparation is less than ½ of the intercuspal distance.

Device Story

DYRACT® EXTRA RESTORATIVE is a hybrid resin-based dental restorative material. It is supplied as a single paste. The material is placed into dental cavities in increments up to 2 mm and cured using visible light. It is intended for use by dental professionals in a clinical setting to fill various cavity classes. The device functions as a restorative material to replace tooth structure. It is used to restore the form and function of teeth affected by decay or damage.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Hybrid resin-based dental restorative material. Single paste formulation. Visible light-cured. Components are established materials used in previously marketed dental devices.

Indications for Use

Indicated for dental patients requiring restoration of cavity classes III, IV, V, and VI, and cavity classes I and II where preparation is less than ½ intercuspal distance.

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

• Dyract® AP Restorative (K973235)
• Quixx® Posterior Restorative (K040144)

Submission Summary (Full Text)

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K050880

APR 2 2 2005

# 510(k) SUMMARY

DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street. Suite 60 York, PA 17405-0872

| CONTACT: | Helen Lewis |
|----------------------------|--------------------------------------------------------------------------|
| DATE PREPARED: | April 1, 2005 |
| TRADE OR PROPRIETARY NAME: | DYRACT® EXTRA RESTORATIVE |
| CLASSIFICATION NAME: | Tooth shade resin material, 872.3690 |
| PREDICATE DEVICES: | Dyract® AP Restorative, K973235<br>Quixx® Posterior Restorative, K040144 |

DYRACT® EXTRA RESTORATIVE is a hybrid resin-DEVICE DESCRIPTION: DEVICE DESCREATIve material for use in filling all dental cavity classes. The direct Composite Testorative maingle paste that is filled into a cavity in increments up to 2 mm before visible light curing.

INTENDED USE: DYRACT® EXTRA RESTORATIVE is indicated for Cavity Classes III, INTENDED OOE. D'ITCTCTC 21 21 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 11 intercuspal distance.

TECHNOLOGICAL CHARACTERISTICS: All of the components in DYRACT® EXTRA TECHNOLOGICAL CHARACTERREAD IN marketed devices and found to be safe for dental use. NESTORATIVE have been assum rogenents of DYRACT® EXTRA RESTORATIVE in the we believe that the prof and of the support the safety and effectiveness of DYRACT® EXTRA RESTORATIVE for the indicated uses.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle-like symbol on the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the left side of the seal.

APR 2 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Helen Lewis Director, Corporate Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872

Re: K050880

Trade/Device Name: Dyract® eXtra Restorative Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: April 04, 2005 Received: April 06, 2005

Dear Ms. Lewis:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(x) premaiter is substantially equivalent (for the indications for referenced above and nave decimilied the ace need in ess marketed in interstate commerce
use stated in the enclosure) to legally markets of marketed in interesthat use stated in the enclosure) to legally man technique in end mentiments, or to devices that proof to May 28, 1970, the chacinent date of the Federal Food. Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Federal PMAA . You may have been reclassified in accordance with the provisions wal application (PMA). You may,
Act (Act) that do not require approval of a premarket approval application of the ge Act (Act) that do not require approval or a prematiconsplay in the Act. The general therefore, market the device, subject to mai general sense par registration, listing of devices, good
controls provisions of the Act include requirements for annial register controls provisions of the Act morade requiritions against misbranding and adulteration.

ﭗ

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (Sec above) interest major regulations affecting your device can be
may be subject to such additional controls. Existing major regulations FDA ma may be subject to such additions, Title 21, Parts 800 to 899. In addition, FDA may publish found in the Code of I caeral in the Federal Register.

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### Page 2 – Ms. Helen Lewis

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that PDA S Issualice of a substition with other requirements of the Act or that FDA has made a delemination that your develop other Federal agencies. You must comply with any Federal statules and regulations administered of to: registration and listing (21 CFR Part 807);
all the Act's requirements, including, but not limited to: set forth in t all the Act's requirements, including, but nor incertains as set forth in the quality.
Iabeling (21 CFR Part 801); good manufacturing procession in the product reading readin labeling (21 CFR Part 801), good manabitant (2) Production (2001), and if applicable, the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if appli systems (QS) regulation (21-531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin manceing your arrial equivalence of your device to a legally premarket nothcation. The PDA Intentify of baosanian organ
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 If you desire specific advice for your do note the regulation of the regulation entitled.
contact the Office of Compliance at [phone]. Also, please note the office of contact the Office of Compulance at (210) 270 of 10.17 PM Part 807.97). You may obtain other
"Misbranding by reference to premarket notification' (21 CFR Part Division of Sw "Misbranding by relefence to premail.cricans.com the Act from the Division of Small
general information on your responsibilities under the Act from the Universe (800) 6 general international on your responsionnes assistance at its toll-free number [phone] or Manufacturers, International and Collsaner Floram. For and Consistencial of Collection of Chindex.html.

Sincerely yours,

Suite y. Mahieu MD.

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 STATEMENT

ﻢ

510(K) Number (if known):

K050880

Device Name:

# DYRACT® EXTRA RESTORATIVE

Indications for Use:

Premarket Notification

Indicated for

- Cavity Classes III, IV, V, and VI .
- Cavity Classes I and II where the cavity preparation is less than ½ of the intercuspal ● distance

Prescription Use __X (Part 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)

Supa Ramsey

wision Sign-Off) vision of Anesthesiology, General Hospital, mection Control, Dental Devices

Number: 1903082

DYRACT® EXTRA RESTORATIVE