(41 days)
AuraLay Pit & Fissure Sealant is used the pits and fissures of teeth. AuraLay is comprised of hydrophilic resins and an HLB composition of fillers. Together these provide optimum properties for sealing and excellent tooth wetting. AuraLay has an extremely high compressive strength. This strength combined with excellent sealing and great esthetics make an excellent choice for sealing of teeth. Aural.ay is available in different fluoride concentrations for different patient use.
AuraLay Pit & Fissure Sealant is used the pits and fissures of teeth. AuraLay is comprised of hydrophilic resins and an HLB composition of fillers. Together these provide optimum properties for sealing and excellent tooth wetting. Aural ay has an extremely high compressive strength. This strength combined with excellent sealing and great esthetics make an excellent choice for sealing of teeth. AuraLay is available in different fluoride concentrations for different patient use.
The provided text is a 510(k) premarket notification for the "AuraLay Pit & Fissure Sealant." This type of submission is a claim of substantial equivalence to a legally marketed predicate device, rather than a submission that presents de novo clinical study data to demonstrate safety and effectiveness.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, a study proving the device meets those criteria, sample sizes, ground truth establishment, or specific performance metrics from a dedicated clinical study.
Instead, the submission relies on the following:
- Substantial Equivalence: The core of this document is the claim that AuraLay Pit & Fissure Sealant is substantially equivalent in design, composition, performance, intended use, and effectiveness to existing predicate devices (CosmeSeal Pit and Fissure Sealant, UltraSeal XT Pit and Fissure Sealant and Flowable Composite Kit, and Delton Clear Pit and Fissure Sealant Kit).
- Predicate Device Performance: The safety and effectiveness are supported by the track record of these predicate devices, which have been found to be substantially equivalent themselves and have been in general usage for about 30 years with a "high benefit-to-risk ratio" and no evidence of short-term or long-term risk.
- NIH Technology Assessment: A reference is made to an NIH Technology Assessment conference regarding "Effects and Side-Effects of Dental Restorative Materials," which states that such materials are "relatively trouble-free" and have "no suspicion of any problems after virtually billions of procedures in the United States."
In summary, there is no direct study described in this document that establishes specific acceptance criteria for the AuraLay Pit & Fissure Sealant and then demonstrates its performance against those criteria using a dedicated test set, ground truth, or statistical analysis (e.g., MRMC or standalone performance). The approval is based on equivalence to already approved and widely used devices.
{0}------------------------------------------------
denali corporation
Image /page/0/Picture/2 description: The image shows a sequence of numbers and a letter. The sequence starts with the letter 'K', followed by the numbers '07', '11', and '58'. The numbers and letter are written in a clear, handwritten style.
Aural.ay Pit & Fissure Sealant
SUMMARY OF SAFETY AND EFFECTIVENESS DATA
Dr. Jan G. Stannard 134 Old Washington Street Hanover, MA 02339-1629
781-826-9190 Telephone Fax 781-826-9190 i_stannard@comcast.net
DEVICE
Trade Name: AuraLav Pit & Fissure Sealant Classification Name: Sealant, Pit and Fissure, and Conditioner FDA Product Code: 76 EBC, 21 CFR Part 872.3765
JUN - 5 2007
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:
AuraLay Pit & Fissure Sealant is used the pits and fissures of teeth. AuraLay is comprised of hydrophilic resins and an HLB composition of fillers. Together these provide optimum properties for sealing and excellent tooth wetting. Aural ay has an extremely high compressive strength. This strength combined with excellent sealing and great esthetics make an excellent choice for sealing of teeth. AuraLay is available in different fluoride concentrations for different patient use.
COMPARISON WITH PREDICATE PRODUCTS:
AuraLay Pit & Fissure Sealant is substantially equivalent in design, composition and intended use to the products listed above. Please see page 20 for the entire comparison.
SAFETY AND EFFECTIVENESS:
The AuraLay 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.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, clutching a staff in its talons. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 5 2007
Dr. Jan G. Stannard President Denali Corporation 134 Old Washington Street Hanover, Massachusetts 02339-1629
Re: K071158
Trade/Device Name: AuraLay Pit & Fissure Sealant Regulation Number: 21 CFR 872.3765 Regulation Name: Pit and Fissure Sealant and Conditioner Regulatory Class: II Product Codes: EBC and LBH Dated: April 23, 2007 Received: April 26, 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.
{2}------------------------------------------------
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 (OS) 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 vours.
Syrite y. Michaud md.
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}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for Denali Corporation. The logo consists of a stylized mountain peak with a circular arc above it, followed by the words "denali corporation" in a bold, sans-serif font. The mountain peak is textured with a pattern of small dots, and the circular arc appears to be a stylized representation of a satellite or orbit.
510 (k) Premarket Notification
AuraLay Pit & Fissure Sealant
INDICATIONS FOR USE STATEMENT
510 (k) Number K071158
(if known)
Device Name AuraLay Pit & Fissure Sealant
Indications for Use:
AuraLay Pit & Fissure Sealant is used the pits and fissures of teeth. AuraLay is comprised of hydrophilic resins and an HLB composition of fillers. Together these provide optimum properties for sealing and excellent tooth wetting. AuraLay has an extremely high compressive strength. This strength combined with excellent sealing and great esthetics make an excellent choice for sealing of teeth. Aural.ay is available in different fluoride concentrations for different patient use.
Please do not write below this line. Continue on another page if needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susa Quinn
ion of Anesthesiology, General Hospital, Jon Control, Dental Devices
3(k) Number: K071158
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use
§ 872.3765 Pit and fissure sealant and conditioner.
(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(b)
Classification. Class II.