APEX UNIVERSAL ADHESIVE

K131043 · Apex Dental Materials, Inc. · KLE · Sep 10, 2013 · Dental

Device Facts

• Record ID: K131043
• Device Name: APEX UNIVERSAL ADHESIVE
• Applicant: Apex Dental Materials, Inc.
• Product Code: KLE · Dental
• Decision Date: Sep 10, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

Apex Universal Adhesive is a single component bonding system for: - Direct Restorations: to seal enamel / dentin prior to restoring with light-cure or self-cure . composite material - Indirect Restorations: bonding light-cured, self-cured or dual-cured composite cements or . glass ionomer or resin-modified glass ionomer cements - Bonding CEREC® restorations . - Desensitization: to treat hypersensitive and / or exposed root surfaces . - Desensitizing crown preparations . - Sealing preparations before placing amalgams ● - Bonding crowns and bridges . - Bonding in posts and cores . - Bonding veneers .

Device Story

Apex Universal Adhesive is a single-component dental bonding agent. It is applied by dental professionals in a clinical setting to tooth structures (enamel/dentin) to facilitate adhesion of restorative materials. The device functions as a chemical interface between the tooth surface and restorative materials, including light-cure, self-cure, or dual-cure composites, glass ionomers, and resin-modified glass ionomers. It is also used for desensitizing exposed root surfaces and crown preparations. The adhesive is applied directly to the prepared site by the clinician, improving the retention and sealing of restorations, crowns, bridges, posts, cores, and veneers. This benefits the patient by providing a stable, durable bond for dental restorations and reducing post-operative sensitivity.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Single-component resin-based dental bonding agent. Formulated for compatibility with light-cure, self-cure, and dual-cure restorative materials. Applied topically to dental surfaces.

Indications for Use

Indicated for dental patients requiring direct or indirect restorations, desensitization of root surfaces or crown preparations, and bonding of crowns, bridges, posts, cores, and veneers. Prescription use only.

Regulatory Classification

Identification

A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

ood and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 10, 2013

Apex Dental Materials, Incorporated C/O Mr. Chris Kulton 330 Telser Road LAKE ZURICH IL 60047

Re: K131043

Trade/Device Name: Apex Universal Adhesive Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: June 10, 2013 Received: June 13, 2013

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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

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## Page 2 - Mr. Kulton

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 Division of Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mary S. Brunner -S

Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation · Center for Devices and Radiological Health

Enclosure

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## Indications for Use:

510(K) Number (if known):

1131043

Device name:

Apex Universal Adhesive

Apex Universal Adhesive is a single component bonding system for:

- Direct Restorations: to seal enamel / dentin prior to restoring with light-cure or self-cure . composite material
- Indirect Restorations: bonding light-cured, self-cured or dual-cured composite cements or . glass ionomer or resin-modified glass ionomer cements
- Bonding CEREC® restorations .
- Desensitization: to treat hypersensitive and / or exposed root surfaces .
- Desensitizing crown preparations .
- Sealing preparations before placing amalgams ●
- Bonding crowns and bridges .
- Bonding in posts and cores .
- Bonding veneers .

Andrew l. Steen -5
2013.09.10 14:03:39 -04'00'

Division Sign-Off) ivision of Anesthesiology, General Hospital nfection Control, Dental Devices

510(k) Number: K131043

## (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)

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510K Submission for Apex Universal Adhesive Apex Dental Materials, 330 Telser Road Lake Zurich, IL 60047

CONFIDENTIAL