LATIT FLOW

K040465 · Ab Ardent · EBF · Jul 20, 2004 · Dental

Device Facts

• Record ID: K040465
• Device Name: LATIT FLOW
• Applicant: Ab Ardent
• Product Code: EBF · Dental
• Decision Date: Jul 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

LATIT FLOW is to be used as a filling material for restoring function to teeth that have lost portions due to caries: Direct, fixed restorations, placed by the dentist after removal of carious tissue. Anterior restorations, Class III, IV Class V restorations, cervical caries, root erosion, wedge shaped defects. Small posterior restorations, Class I. Mini cavities, minimal invasion dentistry Veneering of discolored anterior teeth Splinting of mobile teeth. Preventive restorations in molars and premolars. Repair of composite and ceramic veneers. Luting of porcelain and composite veneers As first layer of Class I or II restorations

Device Story

LATIT FLOW is a tooth shade resin material used by dentists for direct, fixed dental restorations. It functions as a filling material to restore tooth function following caries removal. Applications include anterior and small posterior restorations, veneering, splinting, and luting of veneers. The material is applied by a clinician in a dental office setting. It benefits patients by restoring tooth structure and aesthetics. No complex data processing or software is involved.

Clinical Evidence

Bench testing only.

Technological Characteristics

Tooth shade resin material; Class II device; Product Code EBF; Regulation 872.3690. No software, electronics, or complex sensing mechanisms.

Indications for Use

Indicated for dental patients requiring restoration of tooth structure lost to caries or defects. Includes anterior restorations (Class III, IV, V), cervical caries, root erosion, wedge-shaped defects, small posterior restorations (Class I), mini cavities, veneering, splinting, and luting. Contraindicated if a dry working field cannot be maintained or if the patient has known allergies to device components.

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.

Submission Summary (Full Text)

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

'JUL 2 0 2004

AB Ardent C/O Mr. Clyde E. Ingersoll Official Correspondent & Agent Ardent Product Development 54 Riverview Avenue Tonawanda, New York 14150-5260

Re: K040465

Trade/Device Name: Latit Flow Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: May 18, 2004 Received: May 21, 2004

Dear Mr. Ingersoll:

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 - Mr. Ingersoll

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/dsma/dsmamain.html

Sincerely vours.

Chiu 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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ATTACHMENT #4 Indications for Use

510(k) Number: K040465

Device Name: LATIT FLOW

Indications for Use

LATIT FLOW is to be used as a filling material for restoring function to teeth that have lost portions due to caries:

Direct, fixed restorations, placed by the dentist after removal of carious tissue. Anterior restorations, Class III, IV Class V restorations, cervical caries, root erosion, wedge shaped defects. Small posterior restorations, Class I. Mini cavities, minimal invasion dentistry Veneering of discolored anterior teeth Splinting of mobile teeth. Preventive restorations in molars and premolars. Repair of composite and ceramic veneers. Luting of porcelain and composite veneers As first layer of Class I or II restorations

## Contra indications:

The placement of LATIT FLOW is contraindicated

If a dry working field cannot be established or if the stipulated technique cannot be applied.

If the patient is known to be allergic to the components of LATIT FLOW.

Prescription Use X AND/OR (Part 21 CFR801 Subpart D)

Over-the-counter Use (Part 21 CFR807 Subpart C)

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

concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runser

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

510(k) Number:

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