K Number
K070070
Device Name
ASCENT DENTAL CLEANSER
Manufacturer
Date Cleared
2007-05-25

(137 days)

Product Code
Regulation Number
872.3260
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ascent Dental Cleanser is indicated for: - The cleansing and disinfecting only of tooth cavity preparations in conjunction with dental restorative procedures
Device Description
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.
More Information

Not Found

No
The device description and the "Mentions AI, DNN, or ML" section explicitly state that AI/ML is not found. The device is a chemical cleanser, not a software or imaging device that would typically incorporate AI/ML.

No
The device is indicated for cleansing and disinfecting tooth cavity preparations, which is a preparatory step and not a treatment of a disease or condition itself.

No

The device is described as a cleanser and disinfectant for tooth cavity preparations. Its function is to dislodge material and clean the site, not to diagnose a condition or disease.

No

The device description clearly states it is a "water-based tooth cavity preparation cleanser containing chlorhexidine gluconate and a solvent" and is "dispensed from a prefilled applicator." This indicates a physical substance and a physical delivery mechanism, not a software-only device.

Based on the provided information, the Ascent Dental Cleanser is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVDs are used to examine specimens derived from the human body. The intended use of the Ascent Dental Cleanser is for "cleansing and disinfecting only of tooth cavity preparations in conjunction with dental restorative procedures." This is a direct application to a part of the body (tooth cavity), not the examination of a specimen taken from the body.
  • The device description focuses on its chemical composition and mechanism of action within the tooth cavity. It describes how it dislodges material within the cavity, not how it analyzes or tests a biological sample.
  • There is no mention of analyzing biological samples or providing diagnostic information. The purpose is cleansing and disinfecting, which are therapeutic or procedural actions, not diagnostic ones.

Therefore, the Ascent Dental Cleanser falls under the category of a medical device used for a procedural purpose, not an in vitro diagnostic device.

N/A

Intended Use / Indications for 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.

Ascent Dental Cleanser is indicated for:

  • The cleansing and disinfecting only of tooth cavity preparations in conjunction with dental restorative procedures

Product codes (comma separated list FDA assigned to the subject device)

LBH

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

dental professional

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K021131

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 872.3260 Cavity varnish.

(a)
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.(b)
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.

0

1572

Image /page/0/Picture/1 description: The image shows the text "K070070" written in a handwritten style. The text appears to be a code or identifier. A line is drawn underneath the text, possibly indicating emphasis or underlining.

510(k) Summary of Safety and Effectiveness

CAO GROUP 4628 West Skyhawk Drive West Jordan, UT 84084 Tel: 801.256.9282 Fax: 801.256.9287 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.

1

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.

2

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with its wings spread and head turned to the side. The bird is depicted in a simple, graphic style, with bold black lines.

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.

3

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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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

4

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 UseXOROver-The-Counter Use
-------------------------------------------------

(Per 21 CFR 801.109)

Kai Malay for MSE

ospial,

KO700702-1