PREMISE FLOWABLE

K060472 · Kerr Corporation · EBF · Apr 28, 2006 · Dental

Device Facts

• Record ID: K060472
• Device Name: PREMISE FLOWABLE
• Applicant: Kerr Corporation
• Product Code: EBF · Dental
• Decision Date: Apr 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of Premise Flowable is for use as a filling material for Class I - V restorations. Additional functions include: base/liner material, repair of enamel defects, repair of temporaries, repair of porcelain restorations, minor occlusal build-ups in nonstress bearing areas, pit and fissure sealant, cement for ceramic/composite veneers, incisal abrasions, and core build-ups.

Device Story

Premise Flowable is a nano-filled, light-cure, resin-based dental restorative material. It is supplied in a syringe with single-use tips for clinical application by dental professionals. The material incorporates pre-polymerized fillers and nanofillers to provide strength and durability for various restorative procedures. It is used in dental clinics for filling Class I-V cavities, as a base or liner, for repairing enamel defects, temporaries, and porcelain restorations, as well as for pit and fissure sealing, cementation of veneers, and core build-ups. The clinician applies the material to the tooth structure, which is then cured using a dental light source. The device benefits patients by providing a versatile, durable, and aesthetic restorative option for multiple dental indications.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nano-filled, light-cure, resin-based dental restorative material. Supplied in syringe with single-use tips. Utilizes pre-polymerized filler and nanofiller technology. Class II device, product code EBF, per 21 CFR 872.3690.

Indications for Use

Indicated for use as a filling material for Class I-V dental restorations, base/liner material, repair of enamel defects, repair of temporaries, repair of porcelain restorations, minor occlusal build-ups in nonstress 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 (K060472)

Submission Summary (Full Text)

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APR 2 8 2006

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

# Submitter:

Sybron Dental Specialties, Inc. 100 Bayview Circle, Suite 6000 Newport Beach, California 92660 [phone] - Phone [phone] - Facsimile Colleen Boswell - Contact Person

February 2006 Date Summary Prepared:

### Device Name:

- Trade Name Premise Flowable ◆
- 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:

Premise Flowable is a nano-filled, light-cure, resin restorative material dispensed in a syringe with single-use tips. Premise Flowable uses pre-polymerized filler and nanofillers combined with proven Point 4 technology to deliver strength and durability.

### Intended Use of the Device:

The intended use of Premise Flowable is for use as a filling material for Class I - V restorations. Additional functions include: base/liner material, repair of enamel defects, repair of temporaries, repair of porcelain restorations, minor occlusal build-ups in nonstress bearing areas, pit and fissure sealant, cement for ceramic/composite veneers, incisal abrasions, and core build-ups.

# Substantial Equivalence:

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

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kerr Corporation C/O Ms. Colleen Boswell Sybron Dental Specialties 100 Bayview Circle Suite 6000 Newport Beach, California 92660

APR 2 8 2006

Re: K060472

Trade/Device Name: Premise Flowable Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: February 22, 2006 Received: February 23, 2006

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 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. Colleen Boswell

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" (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,

Chu 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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Section I

# Indications for Use

#### K060472 510(k) Number (if known):

Device Name: Premise Flowable

#### Indications For Use:

Premise Flowable is a nano-filled, light cure, resin dental restorative suitable for Class I -I remise i towable to a natio introl, togner include: base/liner material, repair of enamel v Testorations. Additional ransitions informers in restorations, minor occlusal build-ups in detects, repar of temporaries, repair vs pear vs peramic/composite veneers, incisal abrasions, and core build-ups.

Prescription Use ✓

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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) -11-21 11 0

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