(121 days)
Not Found
No
The device description and performance studies focus on the chemical composition and physical properties of a cleaning gel, with no mention of AI or ML technologies.
No.
The device is described as a cleaning agent for dental restorations external to the mouth, used prior to insertion. It does not treat or cure any disease or condition of the patient.
No
The device is described as a cleaning agent for dental restorations, not for diagnosing conditions or diseases. Its purpose is to cleanse restorations externally before placement in the mouth.
No
The device description clearly states it is a "thin, non-alcohol based gel containing chlorhexidine gluconate" and is provided in "syringes and floc-tipped applicator tips," indicating it is a physical substance and delivery system, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to cleanse dental restorations external to the mouth prior to insertion. This is a cleaning/preparation step for a medical device (the dental restoration), not a diagnostic test performed on a biological sample from the body.
- Mechanism of Action: The device acts as a cleaning agent through its water solubility, abrasive action, and low viscosity. This is a physical/chemical cleaning process, not a diagnostic process that detects or measures substances in a biological sample.
- Lack of Biological Sample Analysis: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze any biological samples.
The device is a cleaning agent for dental restorations, which are medical devices themselves. Its use is external to the body and focused on preparing the restoration, not diagnosing a condition in a patient.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LBH, PME
Device Description
Resolve 2.0 is a thin, non-alcohol based gel containing chlorhexidine gluconate. This thin gel because of its water solubility, abrasive action and low viscosity when applied to dental restorations, acts as a cleaning agent. This gel is provided in easy to use syringes and floc-tipped applicator tips to precisely deliver the gel to the intended areas. For Use only by a Licensed Dentist. Rx Use Only. Non-sterile.
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
Licensed Dentist
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)
The document describes technological characteristic summaries and biocompatibility testing.
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. Key properties compared for Resolve 2.0 and Consepsis include: Cleansing Activity (Yes for both), Contains Chlorhexidine gluconate (Yes for both), Water Soluble (Yes for both), pH (6 for both), Contains silicate (sand) (Yes for both), Consistency (Thin liquid for both), Pigmented (Yes for both), Ageing/Shelf Life Test - Accelerated Ageing at 37°C (PASS, 2.0+ year shelf life established for both).
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."
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.
Consepsis, Ultradent Products (K925375)
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.
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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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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
3
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
134 Old Washington Street
Hanover, MA 02339-1629 | |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| OWNER/CONTACT PERSON | Dr. Jan G. Stannard
TEL:
FAX: | 781-826-9190
781-826-4465
j.stannard@denalicorporation.com |
| 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
under the 510(k) premarket notification process as Class II Dental
Devices under CFR PME 872.3260. | |
| DEVICE DESCRIPTION | Resolve 2.0 is a thin, non-alcohol based gel containing chlorhexidine gluconate.
This thin gel because of its water solubility, abrasive action and low viscosity when
applied to dental restorations, acts as a cleaning agent. This gel is provided in easy
to use syringes and floc-tipped applicator tips to precisely deliver the gel
to the intended areas.
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
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. | |
4
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.