INJECTAFIL

K091647 · Apex Dental Materials, Inc. · EBF · Sep 21, 2009 · Dental

Device Facts

• Record ID: K091647
• Device Name: INJECTAFIL
• Applicant: Apex Dental Materials, Inc.
• Product Code: EBF · Dental
• Decision Date: Sep 21, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Injectafil™ is a dual cured (photo initiated, free radical polymerization and / or peroxide / tertiary amine initiated free radical polymerization) injectable composite material, designed for use as a filling material for all direct dental restorations, a resin cement for the delivery of indirect restorations or a core build up material. Injectafil™ is a composite material which, when utilized properly, provides a material fordirect dental restorations. Injectafil™ can also be used as a resin cement for the delivery of indirect restorations or as a core build up material. Injectafil™ is compatible with all other methactylate based dental materials.

Device Story

Injectafil™ is a dual-cured (photo-initiated and/or peroxide/tertiary amine-initiated free radical polymerization) injectable composite dental material. It is used by dental professionals in a clinical setting for direct dental restorations, as a resin cement for indirect restorations, and for core build-up procedures. The material is compatible with other methacrylate-based dental materials. It is applied directly by the clinician to the tooth structure or restoration site, where it undergoes polymerization to provide a restorative or adhesive function. The device benefits patients by restoring tooth structure, securing indirect restorations, or providing a foundation for crowns/bridges.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dual-cured (photo-initiated and peroxide/tertiary amine-initiated) methacrylate-based composite resin. Injectable form factor. Compatible with methacrylate-based dental materials.

Indications for Use

Indicated for use as a filling material for direct dental restorations, a resin cement for delivery of indirect restorations, and as a core build-up material in dental patients.

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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SEP 21 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Mr. Chris Kulton Apex Dental Materials, Incorporated 330 Telser Road Lake Zurich, Illinois 60047

Re: K091647

Trade/Device Name: InjectafilTM Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF, KLE Dated: September 14, 2009 Received: September 17, 2009

Dear Mr. Kulton:

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- Mr. Kulton

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to http://www.fda.gov/cdrl/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 Division 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:

Injectafil™

Injectafil™ is a dual cured (photo initiated, free radical polymerization and / or peroxide / tertiary amine initiated free radical polymerization) injectable composite material, designed for use as a filling material for all direct dental restorations, a resin cement for the delivery of indirect restorations or a core build up material.

Injectafil™ is a composite material which, when utilized properly, provides a material fordirect dental restorations. Injectafil™ can also be used as a resin cement for the delivery of indirect restorations or as a core build up material. Injectafil™ is compatible with all other methactylate

based dental materials.

Kain Muluy for MS
(Division Sign-Off)
Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

510 (k) Number:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRL, Office of Device Evaluation (ODE)

Prescription use X (Per 21 CFR 801.109 OR

Over- The- Counter Use

(Optional Format 1-2-96)

510K Submission for Injectafil™ Apex Dental Materials, 330 Telser Road Lake Zurich, IL 60047

CONFIDENTIAL

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