BUILD-IT LIGHT CURE

K091512 · Pentron Clinical Technologies · EBF · Oct 30, 2009 · Dental

Device Facts

• Record ID: K091512
• Device Name: BUILD-IT LIGHT CURE
• Applicant: Pentron Clinical Technologies
• Product Code: EBF · Dental
• Decision Date: Oct 30, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Build-It Light Cure is a translucent, light activated composite material designed for core build ups. It is used as core-building material on vital teeth as well as on non-vital teeth, in combination with or without a dental post. It may also be used as a final restorative filling material.

Device Story

Build-It Light Cure is a light-activated, translucent dental composite restorative material. It is used by dental professionals for core build-ups on vital or non-vital teeth, either with or without the use of a dental post, and as a final restorative filling material. The material features a depth of cure greater than 7 mm, facilitating bulk placement. Its consistency allows for easy adaptation to the tooth structure. The device is applied directly by the clinician during dental procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Light-activated composite material consisting of resin and barium borosilicate glass fillers with sodium fluoride. Features a depth of cure > 7 mm. Translucent shade. Class II device (21 CFR 872.3690).

Indications for Use

Indicated for core build-ups on vital and non-vital teeth, with or without dental posts, and as a final restorative filling material.

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

• Clearfil Photo Core (K013488)

Submission Summary (Full Text)

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K091512

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OCT 8.0 2009

## Section III - 510(k) Summary of Safety and Effectiveness

Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 [phone] - Phone [phone] - Facsimile Wendy Garman - Contact Person

May 2009 Date Summary Prepared:

#### . Device Name:

- · Trade Name Build-It Light Cure
- · Common Name Dental Composite Restorative Material
- · Classification Name Tooth Shade Resin Material, per 21 CFR § 872.3690

### Devices for Which Substantial Equivalence is Claimed:

- · Clearfil Photo Core, Kuraray Medical Inc.
#### Device Description:

Build-It light Cure is a line extension to the current two-component dual curable Build-If FR core material. It is available in a translucent shade only. The depth of cure of the material is > 7 mm to facilitate the bulk is available in a tallslucein silade only. The depart of on the resin mixture and the fillers are immy. The combination of the material dalbarumborosilicate glasses with a little sodium fluoride. The cosonially the connecter of the material facilitates easy adaption to the tooth.

#### Intended Use of the Device:

Build-It Light Cure is a translucent, light activated composite material designed for core build ups. I is usets Build-If Light Cure is a nailsluccin; agar actriated composited teeth, in combination with or without a dental v post. It may also be used as a final restorative filling material.

#### Substantial Equivalence:

Suild-It Light Cure is substantially equivalent to other legally marketed devices in the United States. Build-It Light Bulld-It Light Cure is substantary cquiratent to Clica regary an entrently marketed by Kuraray Medical Inc.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Pentron Clinical Technologies, LLC C/O Ms. Wendy Garman Director of Regulatory Affairs Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

OCT 3 0 2009

Re: K091512

Trade/Device Name: Build-It Light Cure Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: September 23, 2009 Received: September 30, 2009

Dear Ms. Garman:

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 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 - Ms. Garman

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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

for

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use

510(k) Number (if known):

Device Name: Build-It Light Cure

Indications For Use:

Build-It Light Cure is a translucent, light activated composite material designed for core build ups. It is used as core-building material on vital teeth as well as on non-vital teeth, in combination with or without a dental post. It may also be used as a final restorative filling material.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

I

Kein Muluy

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

510(k) Number: K091512

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