(57 days)
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No
The description focuses on the material properties and clinical applications of a dental sealant, with no mention of AI or ML capabilities.
Yes
The device is a sealant used for pit and fissure application and sealing of composite enamel margins, which are restorative and preventive dental treatments.
No.
AuraVue is described as a pit and fissure sealant, which is a restorative and preventative dental material, not a diagnostic tool. While it allows for observation of conditions beneath it and the use of caries detecting devices, it does not itself perform a diagnostic function.
No
The device description clearly identifies AuraVue as a "clear pit and fissure sealant," which is a physical material applied to teeth, not a software program.
Based on the provided information, AuraVue is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is a medical device intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, disease or congenital abnormality.
- AuraVue's Intended Use: The intended use of AuraVue is described as a pit and fissure sealant for dental applications. It is applied directly to the tooth surface to seal pits and fissures, prevent leakage, and potentially release fluoride.
- Lack of Specimen Examination: AuraVue does not involve the examination of specimens derived from the human body in vitro. It is a material applied directly to the tooth.
- Information Provided: While the clear nature of AuraVue allows for observation of the tooth surface and potential underlying conditions, this is a visual observation of the in vivo state, not an in vitro analysis of a specimen to provide diagnostic information.
Therefore, AuraVue falls under the category of a dental restorative or preventative material, not an IVD.
N/A
Intended Use / Indications for Use
AuraVue is a clear pit and fissure sealant. Because this material is clear this allows observation of the tooth surface. AuraVue is color stable which allows the material to be indicative of conditions which may occur beneath the sealant. This would include possible leakage, staining and also allows the use of caries detecting devices. AuraVue has excellent sealing ability and has demonstrated clinical success as a sealant. AuraVue is recommended for pit and fissure application and for minimally invasive dentistry. AuraVue is also recommended for sealing of composite enamel marqins and as a composite sealer. AuraVue is available in both fluoride and non-fluoride releasing formulas.
Product codes (comma separated list FDA assigned to the subject device)
76 EBC, EBD
Device Description
AuraVue is a clear pit and fissure sealant. Because this material is clear this allows observation of the tooth surface. AuraVue is color stable which allows the material to be indicative of conditions which may occur beneath the sealant. This would include possible leakage, staining and also allows the use of caries detecting devices. AuraVue has excellent sealing ability and has demonstrated clinical success as a sealant. AuraVue is recommended for pit and fissure application and for minimally invasive dentistry. AuraVue is also recommended for sealing of composite enamel margins and as a composite sealer. AuraVue is available in both fluoride and non-fluoride releasing formulas.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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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)
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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.
CosmeSeal Pit and Fissure Sealant, UltraSeal XT Pit and Fissure Sealant and Flowable Composite Kit, Delton Clear Pit and Fissure Sealant Kit
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.
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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
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
510 (k) Premarket Notification
AuraVue Pit & Fissure Sealant
Image /page/0/Picture/2 description: The image shows the logo for Denali Corporation. The logo consists of a stylized mountain peak with a circular orbit around it, followed by the words "denali corporation" in bold, sans-serif font. The logo is black and white.
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
Dr. Jan G. Stannard 134 Old Washington Street Hanover, MA 02339-1629
Telephone 781-826-9190 Fax 781-826-9190 i_stannard@comcast.net
DEVICE
Trade Name: AuraVue Pit & Fissure Sealant Classification Name: Sealant, Pit and Fissure, and Conditioner FDA Product Code: 76 EBC, 21 CFR Part 872.3765
PREDICATE DEVICES:
CosmeSeal Pit and Fissure Sealant UltraSeal XT Pit and Fissure Sealant and Flowable Composite Kit Delton Clear Pit and Fissure Sealant Kit
DESCRIPTION AND INTENDED USE:
AuraVue is a clear pit and fissure sealant. Because this material is clear this allows observation of the tooth surface. AuraVue is color stable which allows the material to be indicative of conditions which may occur beneath the sealant. This would include possible leakage, staining and also allows the use of caries detecting devices. AuraVue has excellent sealing ability and has demonstrated clinical success as a sealant. AuraVue is recommended for pit and fissure application and for minimally invasive dentistry. AuraVue is also recommended for sealing of composite enamel margins and as a composite sealer. AuraVue is available in both fluoride and non-fluoride releasing formulas.
COMPARISON WITH PREDICATE PRODUCTS:
AuraVue Pit & Fissure Sealant is substantially equivalent in design, composition and intended use to the products listed above.
SAFETY AND EFFECTIVENESS:
The AuraVue Pit & Fissure Sealant is substantially equivalent in design, composition, performance, intended use and effectiveness to the predicate kit products listed above.
The predicate products have been found substantially equivalent under the 510(k) premarket notification process as Class II Dental Devices under CFR EBC 872.3765.
According to the NIH Technology Assessment conference on Effects and Side-Effects of Dental Restorative Materials: "General usage of these materials over about 30 years indicates a high benetif-to-risk ratio...both composites and glass ionomers are relatively trouble-free. There is no evidence of short-term or long-term risk...There is no suspicion of any problems after virtually billions of procedures in the United States.
MAY -- 9 2007
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an eagle with its wings spread, symbolizing the agency's mission to protect the health of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 9 2007
Dr. Jan G. Stannard President Denali Corporation 134 Old Washington Street Hanover, Massachusetts 02339-1629
Re: K070693
Trade/Device Name: AuraVue Pit & Fissure Sealant Regulation Number: 21 CFR 872.3765 Regulation Name: Pit and Fissure Sealant and Conditioner Regulatory Class: II Product Codes: EBC and EBD Dated: April 23, 2007 Received: April 25, 2007
Dear Dr. 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.
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 - Dr. Jan G. Stannard
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 CFR Part 807); labeling (21 CFR Part 801); 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.
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" (21 CFR 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,
Suza Runre
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
3
oration
AuraVue Pit & Fissure Sealant
INDICATIONS FOR USE STATEMENT
510 (k) Number _______________________________________________________________________________________________________________________________________________________________ (if known)
Device Name AuraVue Pit & Fissure Sealant
Indications for Use:
AuraVue is a clear pit and fissure sealant. Because this material is clear this allows observation of the tooth surface. AuraVue is color stable which allows the material to be indicative of conditions which may occur beneath the sealant. This would include possible leakage, staining and also allows the use of caries detecting devices. AuraVue has excellent sealing ability and has demonstrated clinical success as a sealant. AuraVue is recommended for pit and fissure application and for minimally invasive dentistry. AuraVue is also recommended for sealing of composite enamel marqins and as a composite sealer. AuraVue is available in both fluoride and non-fluoride releasing formulas.
Please do not write below this line. Continue on another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
or
Susa Pease
of Anesthasiclegy, General Hospital, Jon Control, Dental Devices
M) Number Y070693
Over-The-Counter Use
Prescription Use
(Per 21 CFR 801.109) V