ACQUASEAL BENZ

K070289 · Acquamed Technologies, Inc. · LBH · May 4, 2007 · Dental

Device Facts

• Record ID: K070289
• Device Name: ACQUASEAL BENZ
• Applicant: Acquamed Technologies, Inc.
• Product Code: LBH · Dental
• Decision Date: May 4, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3260
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Acquaseal Benz is indicated for dental restorative, hypersensitivity, cervical, and hygiene procedures.

Device Story

Acquaseal Benz is a hydrophilic liquid dental bonding agent containing hydroxyethyl-methacrylate (HEMA), fluoride, and benzalkonium fluoride. Applied by dental professionals using a cotton swab, the agent functions as a varnish on sensitive teeth and exposed dentin on roots. Upon application, the material polymerizes to mechanically occlude dentinal tubules, thereby decreasing hypersensitivity. It is used in dental restorative, cervical, and hygiene procedures to eliminate post-treatment sensitivity and treat dentin or cementum sensitivity following root planing or periodontal surgery. The device benefits patients by reducing dental pain and sensitivity associated with exposed dentin and restorative procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Hydrophilic liquid resin bonding agent. Composition: Hydroxyethyl-methacrylate (HEMA), fluoride, and benzalkonium fluoride. Mechanism: Polymerization-based mechanical occlusion of dentinal tubules. Form factor: Liquid for topical application via cotton swab.

Indications for Use

Indicated for dental restorative, hypersensitivity, cervical, and hygiene procedures in patients requiring dental treatment.

Regulatory Classification

Identification

Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.

Special Controls

*Classification.* Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

Predicate Devices

• Hema-Benz (K953405)

Reference Devices

• Hema-Glu (K951220)

Submission Summary (Full Text)

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|<070289

MAY - 4 2007

## SUMMARY & STATEMENT OF COMPARISON (as per 21 CFR 807.92c)

| 1) Submitted by: | Hugh Palmer, Official Correspondent<br>Acquamed Technologies, Inc.<br>33 West 480 Fabyan Parkway, Unit 105<br>West Chicago, IL 60185 (Tel: [phone]) | |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 2) Establishment Registration No: | 3004691767 | |
| 3) Date Prepared: | 01/15/07 | |
| 4) Product Proprietary Name: | Acquaseal Benz | |
| 5) Device Common Name:Resin Tooth Bonding Agent | | |
| 6) Device Classification Name: | Agent, Tooth Bonding, Resin<br>(21 CFR 872.3200) | |
| 7) Device Class: | Class II (KLE) | |
| 8) Substantial equivalence: | The Acquaseal Benz manufactured and marketed by<br>Acquamed Technologies, Inc., is substantially equivalent<br>to the Legally Marketed Predicate: Hema-Benz<br>(K953405) originally manufactured by Health-Dent, Intl.<br>(Refer to section VI of this submission.) | |

The 510(k) Substantial Equivalence Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed as described below:

- 1) The Acquaseal Benz and the Hema Benz listed above have the same intended use, that being as varnish on sensitive teeth, over exposed dentin on exposed dentin on roots.
- 2) The technological characteristics for this product are the same as the predicate device listed as the ingredients are the same. No significant variation has been implemented.
- 3) Descriptive information per the table noted below further show that the materials from the listed predicate devices are substantially equivalent as they are used for the same purpose and have same properties.
- 4) As noted above, the Substantial Equivalence Decision-Making Process Chart was used.

See below for a comparison table showing similarities and differences from the predicate

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devices listed supporting substantial equivalence.

## Similarities:

| AcquaSeal Benz | Legally Marketed Predicate: Hema-Benz<br>(K953405) |
|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Hydrophilic liquid containing Hydroxyethyl- methacrylate (HEMA), Fluoride and Benzakonium Fluoride. | Hydrophilic liquid containing Hydroxyethyl- methacrylate (HEMA), Fluoride and Benzakonium Fluoride. |
| Indicated as a bonding agent for dental restoration. | Indicated as a bonding agent for dental restoration. |
| Desensitizing; Mechanically occludes the dentinal tubules due to polymerization to decrease hypersensitivity. | Desensitizing; Mechanically occludes the dentinal tubules due to polymerization to decrease hypersensitivity. |

## Differences:

| AcquaSeal Benz | Legally Marketed Predicate: Hema-Benz<br>(K953405) |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| As the predicate, the Acquaseal Benz is indicated<br>dental restorative procedures and<br>desensitization, but is also indicated for cervical<br>and hygiene procedures as the liquid is applied<br>with a cotton swab tipped device. | As this product's predecessor, Hema-Glu<br>(K951220) the Hema-Benz is indicated for dental<br>restoration and desensitization. Both of these<br>products are noted for use with adhesive bonding<br>systems and crown and bridge luting agents to<br>eliminate post treatment sensitivity. They are also<br>recommended for the treatment of dentin or<br>cementum sensitivity following root planning and<br>periodontal surgery and can be used prior to<br>placing amalgam restorations.<br>The above referenced products were developed to<br>be applied with a cotton pellet. |

## Conclusion:

Per the review noted above in accordance with the guidance document, the Acquaseal Benz is found to be substantially equivalent to the identified predicate device.

Date:

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Acquamed Technologies, Incorporated C/O Ms. Tammy Lavery Regulatory Affairs, Senior Manager Ultradent Products, Incorporated 505 West 10200 South South Jordan, Utah 84095

MAY - 4 2007

Re: K070289

Trade/Device Name: Acquaseal Benz Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Codes: LBH and KLE Dated: April 25, 2007 Received: April 26, 2007

Dear Ms. Lavery:

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. Tammy Lavery

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Tease be advised that I Drive issualized to your device complies with other requirements of the Act or that FDA has made a doctoring administered by other Federal agencies. You must comply with ally Federal statutes and regulations as limited to: registration and listing (21 CFR Part 807); an the Act 3 requirements; incrading, vefactice requirements as set forth in the quality labeling (21 CFR Part 801); good manager, 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) I ms letter will anow you'to begin mailioning of substantial equivalence of your device to a legally prematics notification: "The PDF macilassification 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 If you desire specific acrive ion 1041) 276-0115. Also, please note the regulation entitled, Colliact the Office of Complanes as (27/2 notification" (21 CFR 807.97). You may obtain other Misorancing of Forerence to promoibilities under the Act from the Division of Small general information on your responsibility of the enumber [phone] or Manufacturers, micrnational and Ocess http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Susan Kune
Chin S. Lin, PhD

Chiu S. Lin, PhD 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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# INDICATIONS FOR USE

107078 510(k) Number (if known):

Device Name: Acquaseal Benz

Indications for Use:

The Acquaseal Benz is indicated for dental restorative, hypersensitivity, cervical, and hygiene procedures.

Prescription Use X AND/OR

(Per 21 801 CFR Subpart D)

Over-The-Counter Use

(Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Russer

Page 1 of 1 (Posted November 13, 2003)

1. 1. 1. 1 The of Anesthestology, General Hospital, John Control, Dental Devices 1 1 0(k) Number ____