(30 days)
Hydro-Cast Dental 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.
The Hydro-Cast Etching Gel is a 35% phosphoric acid solution. It can be applied with a micro-brush, syringe, or pipette.
The provided document describes the Hydro-Cast Dental Etching Gel and its substantial equivalence to a predicate device. This submission is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through extensive clinical trials with acceptance criteria directly linked to clinical outcomes for the new device itself.
Therefore, the information you're requesting regarding acceptance criteria, specific studies proving the device meets those criteria, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies, is largely not present in this type of submission for this particular device.
Here's why and what information is provided:
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Nature of the Device and Submission: The Hydro-Cast Dental Etching Gel is a material used to prepare a tooth surface. Its function is to create a suitable surface for bonding, which is a chemical/physical process. The submission is a 510(k), which aims to show that the new device is "substantially equivalent" to a legally marketed predicate device (Orthosource Etch Systems, K861245). Substantial equivalence is often demonstrated through a comparison of technological characteristics and performance data that shows the new device is as safe and effective as the predicate.
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Focus on "Substantial Equivalence": For devices like this, the "acceptance criteria" are typically related to a demonstration that the new device performs similarly to or within acceptable parameters compared to the predicate, particularly in its intended use. There isn't a pre-defined set of clinical outcome metrics that the new device needs to meet independently, but rather a comparison to the established predicate.
Here's a breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Technological Characteristics: Identical composition and intended use to the predicate device (Orthosource Etch Systems). | "Preparation of phosphoric acid, reagent grade water, FD&C coloring agents, xanthan gum." (Identical to predicate's listed components). "Summary: The technological characteristics of the two devices are identical." |
| Functional Performance (Etching & Bonding): Must adequately prepare the enamel surface to allow for good adhesion and desired bond strength with a dental adhesive. | "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." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: "five random subgroups with three samples drawn from each" (total of 15 samples).
- Data Provenance: Not specified, but generally assumed to be from the manufacturer's internal testing facilities, likely in the US (Kansas City, MO, where the company is located). The testing is prospective for the purpose of this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/mentioned. The "ground truth" for this device's performance is inferred from the physical outcome of etching and bonding, rather than expert interpretation of images or clinical diagnoses. The assessment of whether "the adhesive cured well, and the bond strength desired was attained" would likely be through standardized laboratory testing methods, not expert consensus on qualitative observations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/mentioned. Adjudication methods are typically relevant for human interpretation tasks, not for the objective measurement of physical properties like bond strength.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a dental etching gel, not an AI-assisted diagnostic tool or an imaging device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" here is based on objective physical measurements or observations of material performance:
- Compositional analysis: Verifying the ingredients of the gel.
- Bond strength testing: Measuring the strength of the bond formed after etching, compared to established standards for dental adhesives.
- Curing observation: Verifying if the adhesive cured properly on the etched surface.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML model that requires a training set. The "samples" referred to in the performance testing are physical samples of the product.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this type of device submission.
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3/3/99
K990300
SUMMARY
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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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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.
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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.
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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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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)
§ 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.