ASCENT DENTAL CLEANSER

K070070 · CAO Group, Inc. · LBH · May 25, 2007 · Dental

Device Facts

• Record ID: K070070
• Device Name: ASCENT DENTAL CLEANSER
• Applicant: CAO Group, Inc.
• Product Code: LBH · Dental
• Decision Date: May 25, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3260
• Device Class: Class 2

Intended Use

The Ascent Dental Cleanser is intended for cleaning and disinfecting cavity proparations in conjunction with dental restorative procedures. The water-based preparation, when introduced into a cavity preparation, works to dislodge unwanted and/or foreign matcrial. The amount of time the material is introduced at the site is determined by the dental professional as dictated by the location of the site and the extent of cleansing that is required. This material is used independently or in conjunction with other devices to achieve the level of cleansing desired.

Device Story

Ascent Dental Cleanser is a water-based dental cavity preparation cleanser containing chlorhexidine gluconate and a solvent. Used by dental professionals in a clinical setting during restorative procedures to dislodge foreign material from cavity preparations. Dispensed via prefilled applicator, either as a single-use unit dose or a larger quantity with disposable tips. The clinician applies the cleanser directly to the site; duration of application is determined by the professional based on site location and required cleansing extent. The device functions to clean and disinfect the cavity, potentially improving the environment for subsequent restorative materials.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use comparisons.

Technological Characteristics

Water-based dental cavity cleanser containing chlorhexidine gluconate and a solvent. Supplied in prefilled applicators with disposable tips. Non-electronic, manual application.

Indications for Use

Indicated for the cleansing and disinfecting of tooth cavity preparations in conjunction with dental restorative procedures.

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

• Chloraprep (K021131)

Submission Summary (Full Text)

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### 510(k) Summary of Safety and Effectiveness

CAO GROUP 4628 West Skyhawk Drive West Jordan, UT 84084 Tel: [phone] Fax: [phone] www.caogroup.com Robert K. Larsen, Operations Director Preparation Date: May 14, 2007

MAY 2 5 2007

#### Device Name:

| Trade Name: | Ascent Dental Cleanser |
|-------------------------|------------------------------------------------------|
| Common Name: | Dental cleansing material |
| Product Classification: | Varnish, Cavity (21 CFR 872.3260, Product Code: LBH) |

#### Legally Marketed Predicate Devices for Substantial Equivalence:

- Chloraprep, Manufactured by Centrix, Inc. . 510(k) Number: K021131
#### Rationale for Substantial Equivalence:

The aforementioned device shares similarities for the purpose of cleansing cavities in conjunction with dental restorative procedures. This device features similar indications for use and application methods to the predicate device.

#### Description of Submitted Device:

The Ascent Dental Cleanser is a water-based tooth cavity preparation cleanser containing chlorhexidine gluconate and a solvent. This composition, when introduced into a cavity preparation, works to dislodge unwanted and/or foreign material. The cleanser is dispensed from a prefilled applicator directly to the desired site. The applicator may be in the form of a one-time unit dose configuration, or may be supplied in a larger prefilled quantity that accommodates single-use disposable tips of varying size and length to accommodate the needs of a particular procedure. Exact information regarding the material's constituents is found in Part 8: Biocompatibility Assessment.

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K0700870

## Intended Uses of the Ascent Dental Cleanser:

The Ascent Dental Cleanser is intended for cleaning and disinfecting cavity proparations in conjunction with dental restorative procedures. The water-based preparation, when introduced into a cavity preparation, works to dislodge unwanted and/or foreign matcrial. The amount of time the material is introduced at the site is determined by the dental professional as dictated by the location of the site and the extent of cleansing that is required. This material is used independently or in conjunction with other devices to achieve the level of cleansing desired.

# Technological Characteristics of Substantial Equivalence:

Both the submitted and predicate device are composed of similar substances, with similar active constituents in similar concentrations. Both have similar indications for use. Both have similar methods of application. Both are used in conjunction with dental restorative procedures. A comparison table of the predicate device and submitted device is contained in Part 7: Performance Data.

### Performance Standards:

None

### Performance Data

See Part 7: Performance Data

#### Conclusion

The Ascent Dental Cleanser is substantially equivalent to the aforementioned predicate device with regards to purpose of the device, general composition, methods of application, and indications for use without raising any new issues regarding safety and/or effectiveness.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robert K. Larsen Operations Director CAO Group, Incorporated 4628 West Skyhawk Drive West Jordan, Utah 84084

MAY 2 5 2007

Re: K070070

Trade/Device Name: Ascent Dental Cleanser Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: May 14, 2007 Received: May 15, 2007

Dear Mr. Larsen:

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. Larsen

Please be advised that FDA's issuance of a substantial equivalence determination docs 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 and ilsuing (21 et read 007), 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,

Suzette Y. Mckend md.

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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Ko70070

# Indications for Use

510(k) Number (if known):

Device Name: Ascent Dental Cleanser

Indications For Use:

Ascent Dental Cleanser is indicated for:

- · The cleansing and disinfecting only of tooth cavity preparations in conjunction with dental restorative procedures
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | X | OR | Over-The-Counter Use | |
|------------------|---|----|----------------------|--|
|------------------|---|----|----------------------|--|

(Per 21 CFR 801.109)

Kai Malay for MSE

ospial,

KO70070^2-1