POINT 4 FLOWABLE 2

K013325 · Kerr Dental Materials Center · EBF · Oct 23, 2001 · Dental

Device Facts

• Record ID: K013325
• Device Name: POINT 4 FLOWABLE 2
• Applicant: Kerr Dental Materials Center
• Product Code: EBF · Dental
• Decision Date: Oct 23, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Point 4 Flowable 2 is a low viscosity light cure hybrid resin restorative suitable for Class III, Class IV, and Class V restorations. Additional functions include: repair of enamel defects, repair of porcelain restorations, minor occlusal build-ups in non-stress bearing areas, pit and fissure sealant, cement for ceramic/composite veneers, incisal abrasions, and core build-ups.

Device Story

Point 4 Flowable 2 is a low-viscosity, light-curable hybrid resin restorative material. Used by dental professionals in clinical settings for restorative procedures, including Class III, IV, and V restorations, enamel/porcelain repair, and core build-ups. Material is applied to the tooth structure and cured using a dental light source. Provides structural repair and aesthetic restoration of dental defects.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Low-viscosity light-cure hybrid resin restorative material. Class II device (21 CFR 872.3690).

Indications for Use

Indicated for Class III, IV, and V dental restorations; repair of enamel defects and porcelain restorations; minor occlusal build-ups in non-stress bearing areas; pit and fissure sealant; cement for ceramic/composite veneers; incisal abrasions; and core build-ups.

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

• Point 4 Flowable (Kerr Corporation)

Submission Summary (Full Text)

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OCT 2 4 2001

Image /page/0/Picture/1 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above the letters. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are written in a bold, sans-serif font. The logo is in black and white.

K013325

## RON DENTAL SPECIALTIES

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 Colleen Boswell - Contact Person

Date Summary Prepared: October 2001

#### Device Name:

- Trade Name Point 4 Flowable 2 .
- Common Name Light-Curable Dental Restorative Material .
- Classification Name Tooth Shade Resin Material, per 21 CFR § 872.3690 .

#### Devices for Which Substantial Equivalence is Claimed:

- Kerr Corporation, Point 4 Flowable .
#### Device Description:

Point 4 Flowable 2 is a low viscosity light cure hybrid resin restorative suitable for Class III, Class IV, and Class V restorations. Additional functions include: repair of enamel defects, repair of porcelain restorations, minor occlusal build-ups in non-stress bearing areas, pit and fissure sealant, cement for ceramic/composite veneers, incisal abrasions, and core build-ups.

#### Intended Use of the Device:

The intended use of Point 4 Flowable 2 is for use as a filling material for Class III, Class IV, and Class V restorations. Additional functions include: repair of enamel defects, repair of porcelain restorations, minor occlusal build-ups in non-stress bearing areas, pit and fissure sealant, cement for ceramic/composite veneers, incisal abrasions, and core build-ups.

#### Substantial Equivalence:

Point 4 Flowable 2 is substantially equivalent to other legally marketed devices in the United States. The composite restorative marketed by Kerr Corporation functions in a manner similar to and is intended for the same use as the product manufactured by Kerr Dental Materials Center.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or a bird in flight, represented by three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 4 2001

Ms. Colleen Boswell Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

Re: K013325

Trade/Device Name: Point 4 Flowable 2 Regulation Number: 21 CFR 872.3690 Regulation Name: Light-Curable Dental Restorative Material Regulatory Class: Class II Product Code: EBF Dated: October 4, 2001 Received: October 5, 2001

Dear Ms. Boswell:

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 vour 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.

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Boswell

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely,

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# KO13325

#### Section I

## Indications for Use Statement

Ver/ 3 - 4/24/96

Applicant: Kerr Dental Material Center

510(k) Number (if known): K013325

Device Name: Point 4 Flowable 2

Indications For Use:

Point 4 Flowable 2 is a low viscosity light cure hybrid resin restorative suitable for Class III,
Class IV, and Class V restorations. Additional functions include: repair of enamel defects, repair
of porcelain restorations, minor occlusal build-ups in non-stress bearing areas, pit and fissure
sealant, cement for ceramic/composite veneers, incisal abrasions, and core build-ups.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)
(Optional Format 1-2-96)

(Division Sign-Off)
Division of Dental, Infection Contro,
and General Hospital Devices
510(k) Number K01332分