Resolve 2.0

K152322 · Denali Corporation · PME · Dec 16, 2015 · Dental

Device Facts

• Record ID: K152322
• Device Name: Resolve 2.0
• Applicant: Denali Corporation
• Product Code: PME · Dental
• Decision Date: Dec 16, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3260
• Device Class: Class 2

Intended Use

Resolve 2.0 is recommended for use on dental restorations, external to the mouth, prior to insertion into the mouth. After applying Resolve 2.0 to cleanse the restoration, the surface of the restoration should be washed thoroughly with water, and then air dried before placement in the mouth. For Use only by a Licensed Dentist. Rx Use Only. Non-sterile.

Device Story

Resolve 2.0 is a non-alcohol based chlorhexidine gluconate gel used as a cleaning agent for dental restorations. The device is supplied in syringes with floc-tipped applicators for precise delivery. It is applied to restorations external to the mouth, followed by water rinsing and air drying before placement. Used by licensed dentists in a clinical setting. The gel's water solubility and abrasive action facilitate the removal of contaminants from the restoration surface, potentially improving the quality of the final dental restoration placement.

Clinical Evidence

Bench testing only. Evidence includes comparative analysis of physical properties (pH, water solubility, cleansing activity), shelf-life testing (accelerated aging at 37°C), and biocompatibility testing per ISO 10993-5. Both Resolve 2.0 and the predicate exhibited 'Moderate' cytotoxicity reactivity zones up to 1.0 cm.

Technological Characteristics

Non-alcohol based gel containing chlorhexidine gluconate and silicate (sand). pH 6. Water soluble. Thin liquid consistency. Delivered via syringe and floc-tipped applicator. Biocompatibility evaluated per ISO 10993-5. Shelf life established via accelerated aging at 37°C.

Indications for Use

Indicated for cleansing dental restorations external to the mouth prior to insertion. For use by licensed dentists only.

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

• Consepsis, Ultradent Products (k925375)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a central emblem. The emblem consists of a stylized representation of three human profiles facing right, stacked on top of each other, symbolizing health and human services.

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

December 16, 2015

Denali Corporation Jan G. Stannard President 134 Old Washington Street Hanover, Massachusetts 02339

Re: K152322

Trade/Device Name: Resolve 2.0 Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity varnish Regulatory Class: Class II Product Code: LBH Dated: November 4, 2015 Received: November 9, 2015

Dear Ms. Jan G. Stannard:

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 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

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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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

# Erin I. Keith -S

Erin I. Keith, M.S. 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 STATEMENT

510 (k) Number 152322

Device Name

Resolve 2.0

Indications for Use:

Resolve 2.0 is recommended for use on dental restorations, external to the mouth, prior to insertion into the mouth. After applying Resolve 2.0 to cleanse the restoration, the surface of the restoration should be washed thoroughly with water, and then air dried before placement in the mouth.

For Use only by a Licensed Dentist. Rx Use Only. Non-sterile.

Please do not write below this line. Continue on another page if needed.

Concurrence of CDRH, Office of Device Evaluation (ODE)

or

区

Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use

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## denali corporation 134 Old Washington Street
Hanover, MA 023339 USA

# T 781.826.9190
F 781.826.4465
denalicorporation.com

### 510 (k) Summary

December 10, 2015

| ADDRESS | DENALI CORPORATION<br>134 Old Washington Street<br>Hanover, MA 02339-1629 | |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| OWNER/CONTACT PERSON | Dr. Jan G. Stannard<br>TEL:<br>FAX: | 781-826-9190<br>781-826-4465<br>[e-mail] |
| TRADE NAME | Resolve 2.0 | |
| COMMON NAME | External Cleansing Solution, Cavity Varnish | |
| CLASSIFICATION NAME | Cavity Varnish, Class II (21 CFR 872.3260, Product Code PME) | |
| REGISTRATION | 3006367836 | |
| PRIMARY PREDICATE DEVICE | Consepsis, Ultradent Products (k925375) | |
| EQUIVALENCE | The predicate product has been found substantially equivalent<br>under the 510(k) premarket notification process as Class II Dental<br>Devices under CFR PME 872.3260. | |
| DEVICE DESCRIPTION | Resolve 2.0 is a thin, non-alcohol based gel containing chlorhexidine gluconate.<br>This thin gel because of its water solubility, abrasive action and low viscosity when<br>applied to dental restorations, acts as a cleaning agent. This gel is provided in easy<br>to use syringes and floc-tipped applicator tips to precisely deliver the gel<br>to the intended areas.<br>For Use only by a Licensed Dentist. Rx Use Only. Non-sterile. | |
| INTENDED USE | Resolve 2.0 is recommended for use on dental restorations, external to the<br>mouth, prior to insertion into the mouth. After applying Resolve 2.0 to cleanse the<br>restoration, the surface of the restoration should be washed thoroughly with<br>water, and then air dried before placement in the mouth.<br>For Use only by a Licensed Dentist. Rx Use Only. Non-sterile. | |

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Image /page/4/Picture/0 description: The image shows the logo for Denali Corporation. The logo features a blue and black geometric shape with a blue sphere and a curved line around it. Next to the logo is the text "denali corporation" in gray. Below the company name is the address "134 Old Washington Street, Hanover, MA 02339 USA".

T 781.826.9190 F 781.826.4465 denalicorporation.com

#### TECHNOLOGICAL CHARACTERISTICS SUMMARY

Resolve 2.0 has the same technological characteristics as Consepsis including: design, composition, biocompatibility, performance, ageing, intended use, physical characteristics, including pH, shelf life, water solubility, and cleansing activity, as summarized in the Table below.

| PROPERTY | Resolve 2.0 | Consepsis* |
|-----------------------------------------------------|----------------------------------------|----------------------------------------|
| Cleansing Activity | Yes | Yes |
| Contains Chlorhexidine gluconate | Yes | Yes |
| Water Soluble | Yes | Yes |
| pH | 6 | 6 |
| Contains silicate (sand) | Yes | Yes |
| Consistency | Thin liquid | Thin liquid |
| Pigmented | Yes | Yes |
| Ageing/Shelf Life Test - Accelerated Ageing at 37°C | PASS, 2.0+ year shelf life established | PASS, 2.0+ year shelf life established |

BIOCOMPATIBILITY

Resolve 2.0 was found to be biocompatible, and is consistent in formulation to Consepsis, in its limited intended uses, biocompatibility, and properties, Resolve 2.0 was evaluated per ISO 10993-5 "Biological Evaluation of Medical Devices". Resolve 2.0 and Consepsis according to ISO 10993-5 both had cytotoxicity values of "Moderate", exhibiting a reactivity zone extending from the specimen up to 1.0 cm. According to these results Resolve 2.0 was found to be equivalent in biocompatibilty compared to the predicate product Consepsis.

SUBSTANTIAL Resolve 2.0 is substantially equivalent in design, composition, biocompatibility EQUIVALENCE according to ISO 10993, performance, ageing, limited intended uses, and safety DETERMINATION and effectiveness to Consepsis. This assessment is based upon a comparison AND SUMMARY of the composition and physical properties of water solubility, pH, shelf-life and cleansing activity to Consepsis, as well as Biocompatibility evaluation. The results of these tests are consistent with values of the predicate product.

CONCLUSIONS Resolve 2.0 has been found to be substantially equivalent in design, composition, ageing, biocompatibility, performance, with limited intended uses to Consepsis.