(73 days)
Not Found
No
The device description and intended use focus on the chemical properties and function of a silane coupler for dental bonding, with no mention of AI or ML technologies.
No.
Prilane is a silane coupler used to improve the adhesion of dental restorative materials to porcelain, acting as a bonding agent rather than directly treating or mitigating a disease or condition for a therapeutic purpose.
No.
Explanation: Prilane is described as a silane coupler used to repair fractured dental porcelain and bond porcelain restorations, improving adhesion and strength. Its function is to facilitate bonding of restorative materials, not to diagnose a condition or disease.
No
The device description clearly states that Prilane is a liquid chemical substance (silane coupler) intended for physical application to dental surfaces. This is a material, 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 repair fractured dental porcelain and bond all porcelain restorations. This is a direct application to a material (dental porcelain) and a tooth surface, not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The device is a silane coupler that chemically bonds to inorganic surfaces and organic resins. This describes a material used for adhesion and repair, not a diagnostic test.
- Anatomical Site: The anatomical site is dental porcelain and etched tooth surface. While these are within the oral cavity, the device is acting on the materials themselves, not analyzing biological samples from the patient.
- Lack of Diagnostic Information: There is no mention of the device being used to detect, measure, or analyze any substance or characteristic in a biological specimen to provide diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information about a person's health. This device is used in vivo (within the body, on dental materials) for a restorative purpose.
N/A
Intended Use / Indications for Use
" Prilane is indicated as part of a system to repair fractured dental porcelain and to bond all porcelain restorations. The system involves etching the porcelain and then applying a small amount of Prilane to the etched surface.
Product codes
EIH
Device Description
Prilane is a silane coupler, a device that when applied to inorganic suffaces such as dental porcelain, will chemically bond to the porcelain and will then bond to the organic thermoset resins that are commonly used as luting agents and estorative materials in dentistry. The above results in: Improved adhesion. Increased composite wet & dry strength. Increased composite wet & dry flexural strength. Prilane is a clear, low viscosity liquid having a pH of 6. Prilane is a prehydrolized sillane. The hydrolization involves adding a small amount of water (.125%) to the silane. The hydrolization reaction causes the silane to be both organic and inorganic reactive. The silane material is Dow Corning Z-6030 which is -methacryloxypropyctrimethoxy silane.
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
dentists
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)
Not Found
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.
0
JUL 1 0 1998
Date: July 2, 1998
510(K) Summery
ibmitter; Gresco Products, Inc. 13391 Murphy Rd. Stafford, TX 77477 (281)261-1811
Contact person: Clinton D. Vaupel Device name: Prilane Common name: Silane Coupler Classification name: Unknown
· Prilane is substantially equivalent to Fusion marketed by Geo Taub Co. and Gerinate Prime marketed by Denmat. Both products were marketed prior to May 28, 1976. Both of the above products are silane couplers. These products are similar chemically but differ in that they must be hydrolized prior to use.
Scotch Prime, 510(K) number K853698, marketed by 3M is very similar to Prilane. Both are prehydrolized and ready to use in the purchased state. Both use sopropanol as a vehicle.
Description: Prilane is a silane coupler, a device that when applied to inorganic suffaces such as dental porcelain, will chemically bond to the porcelain and will then bond to the organic thermoset resins that are commonly used as luting agents and estorative materials in dentistry.
The above results in:
Improved adhesion.
Increased composite wet & dry strength.
Increased composite wet & dry flexural strength.
Prilane is a clear, low viscosity liquid having a pH of 6. Prilane is a prehydrolized sillane. The hydrolization involves adding a small amount of water (.125%) to the silane. The hydrolization reaction causes the silane to be both organic and inorganic reactive. The silane material is Dow Corning Z-6030 which is -methacryloxypropyctrimethoxy silane.
Intended use: There are two(2) intended uses of Prilane.
Repair of fractured porcelain:
Occasionally dental restorations that are made of porcelain will chip or
1
11:34 07/02/1998
fracture. When this happens, many times the dentist prefers to repair fracture. When this happens, ing it with a new crown or bridge. This repair procedure involves the following steps.
a. Etch porcelain with porcelain etchant.
- Apply Prilane or other silane to porcelain sufface and dry.
Apply Prilane or other silane to porcelain surface silens b. - c. Apply Bis-Gma unfilled resin over Prilane or other sillane.
- c. Apply Bis-Gma Restorative Resin over unfilled resin and light cure.
d. Apply Bis-Gma Restorative Resin over unfilled resin and light cure. - Bonding all porcelain restorations:
- Bonding all porcelain restorations.
Many dental restoration are now made totally of dental porcelain. To insure of restoration is always bonded with a composite luting resin. To insure of restoration is always bondou think a complex or other silane is used as one of the steps.
The all porcelain bonding steps are:
- Etch porcelain with porcelain etchant.
- Etch tooth with tooth etchant. b.
- Elon tooth with tool reterial.
Apply Prilane or other silane to etched porcelain interface and air dry. G.
- Apply Bis-Gma unfilled resin to porcelain interface. d.
- Apply Bis-Gma unfilled resin to etched tooth surface. e.
- Apply Bis-Gma Chiling Cement to interface of porcelain restoration. f.
- Seat porcelain on tooth to be restored a.
Prilane as stated earlier is similar to several legally marketed devices. All of these devices are chemically similar to similar to same purpose and all use a common silane raw material vendor. That vendor being Dow Corning.
· Prilane is never used on living tissue.
Philane is nevel used on noing tions and by dentists for over 25 years in millions of a - Silane materials nave been assure by contract an adverse or toxic reaction.
applications with, to the best of our knowledge never an adverse or toxic reaction.
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" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 10 1998
Mr. Clinton D. Vaupel ·President Gresco Products, Incorporated 13391 Murphy Road Stafford, Texas 77477
Re : K981524 Trade Name: Prilane Regulatory Class: II Product Code: EIH May 29, 1998 Dated: June 1, 1998 Received:
Dear Mr. Vaupel:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੈ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
3
Page 2 - Mr. Vaupel
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
11 : 34
GRESCO PRODUCTS
Alat
Image /page/4/Picture/4 description: The image shows a sequence of handwritten characters. The characters are K, 9, 8, 1, 5, and 2. The characters are written in black ink and are clearly visible against a white background.
510(K) number: K981524 Device name: Prilane
Indications for use:
. . .
ndications for use:
" Prilane is indicated as part of a system to repair fractured dental porcelain
the Prilane is indicated as a stantians and to bond all porcelain restorations.
d to bond all porcelain restorations.
The system involves etching the porcelain and then applying a small amount of Prilane to the etched surface.
Susan Runner
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices KG15 510(k) Number .
: