(30 days)
Not Found
No
The device is a chemical etching gel and the description focuses on its chemical composition and application method. There is no mention of AI/ML or any computational processing.
No.
The device is used to prepare the tooth surface for a dental adhesive, which is a preparatory step rather than a direct treatment for a disease, injury, or to restore, correct, or modify a bodily function.
No.
The device is an etching gel used to prepare the tooth surface for dental adhesive, which is a treatment preparation rather than a diagnostic process.
No
The device is a chemical substance (etching gel) and not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prepare the surface of a tooth before a dental adhesive is used. This is a direct application to the tooth surface for a physical/chemical effect on the tooth itself, not for testing a sample from the body to diagnose a condition.
- Device Description: It's a phosphoric acid solution applied directly to the tooth.
- Performance Studies: The performance studies focus on the effectiveness of the etching gel in preparing the tooth surface for adhesive bonding, not on analyzing a biological sample.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
Hydro-Cast Etching Gel is used to prepare the surface of the tooth before a dental adhesive is used. It is applied directly on the tooth, and after fifteen seconds, the tooth is rinsed and dried.
Hydro-Cast Dental Etching Gel is used to prepare the tooth surface before a dental adhesive is used. It is applied directly on the tooth surface, the area is rinsed and dried after fifteen seconds, and then tooth surface is ready for the adhesive.
Product codes (comma separated list FDA assigned to the subject device)
EBC
Device Description
The Hydro-Cast Etching Gel is a 35% phosphoric acid solution. It can be applied with a micro-brush, syringe, or pipette.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth surface
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 testing of Hydro-Cast Dental Etching Gel was conducted using five random subgroups with three samples drawn from each. Etching gel from each sample was placed on an enamel surface. After fifteen seconds, a single component adhesive was applied to each sample. The adhesive cured well, and the bond strength desired was attained.
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.
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
§ 872.3765 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.
0
3/3/99
K990300
SUMMARY
Page 1S
1
Date Prepared 01/28/99
Submitted by Clark Smith D.M.D.
Kay-See Dental 124 East Missouri Avenue Kansas City, MO 64106
Telephone 800-842-8844 Fax 816-842-3204
Prepared by Barry Hale C.Q.E. 7707 E 201 terr Belton, MO 64012 816-322-4641
Contact Clark Smith D.M.D.
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Trade name - Hydro-Cast Dental Etching Gel
Common name - Dental Etching Gel
Classification Name - Sealant, Pit, and Fissure, and Conditioner (872.3765)
Substantial equivalence claimed to - Orthosource Etch Systems, 872.3765, K861245
Description of the device.
The Hydro-Cast Etching Gel is a 35% phosphoric acid solution. It can be applied with a micro-brush, syringe, or pipette.
Intended use of device.
Hydro-Cast Etching Gel is used to prepare the surface of the tooth before a dental adhesive is used. It is applied directly on the tooth, and after fifteen seconds, the tooth is rinsed and dried.
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3
TECHNOLOGICAL CHARACTERISIC COMPARISON
Orthosource Etch Systems
Hydro-Cast Etching Gel
Mixture of phosphoric acid, water, coloring agents, xanthan gum.
Preparation of phosphoric acid, reagent grade water, FD&C coloring agents, xanthan gum.
Summary: The technological characteristics of the two devices are identical.
4
DISCUSSION NON-CLINICAL PERFORMANCE TESTING AND DATA
The testing of Hydro-Cast Dental Etching Gel was conducted using five random subgroups with three samples drawn from each. Etching gel from each sample was placed on an enamel surface. After fifteen seconds, a single component adhesive was applied to each sample. The adhesive cured well, and the bond strength desired was attained.
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling a caduceus, with three horizontal lines above a staff entwined with a snake.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 3 1999"
Clark Smith, D.M.D. Executive Vice President Kay-See Dental Manufacturing Company 124 East Missouri Avenue Kansas City, Missouri 64106-1294
Re : K990306 Hydro-Cast Dental Etching Gel. Model 60025 Trade Name: Requlatory Class: ı i Product Code: EBC Dated: January 29, 1999 Received: February 1, 1999
Dear Dr. Smith
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 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, Druq, 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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Page 2 - Dr. Smith
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 requlation (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" (21 CFR 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/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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Image /page/7/Picture/0 description: The image shows a black and white picture with a large black dot on the left side. There are also some scattered black spots and lines on the right side of the image. The overall impression is that the image is a low-quality scan or photocopy of a document or object with some imperfections.
STATEMENT OF INDICATIONS FOR USE
Hydro-Cast Dental Etching Gel is used to prepare the tooth surface before a dental adhesive is used. It is applied directly on the tooth surface, the area is rinsed and dried after fifteen seconds, and then tooth surface is ready for the adhesive.
Clark Smith D.M.D
Susan Ruane
(Division Sign-Off) (Division Sign-Oir)
Division of Dental, Infection Control, Divisioneral Hospital Devices 1999-906 510(k) Number
Prescription Use . (Per 21 CFR 801.109)