Who is the manufacturer of HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025?

Kay See Dental Mfg. Co. filed the 510(k) submission for HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025 (K990306).

What is the FDA product code for HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025?

EBC. It is classified under 21 CFR 872.3765 as a Class 2 device in the Dental panel.

What is the regulatory pathway for HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025?

510(k) clearance (submission type: Traditional).

What are the predicate devices for HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025?

Orthosource Etch Systems (K861245).

Who can help prepare an FDA 510(k) submission like HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025

K990306 · Kay See Dental Mfg. Co. · EBC · Mar 3, 1999 · Dental

Device Facts

Record ID	K990306
Device Name	HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025
Applicant	Kay See Dental Mfg. Co.
Product Code	EBC · Dental
Decision Date	Mar 3, 1999
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3765
Device Class	Class 2

Intended 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.

Device Story

Hydro-Cast Dental Etching Gel is a 35% phosphoric acid solution used in dental clinics by dentists. The gel is applied directly to the tooth surface via micro-brush, syringe, or pipette to etch the enamel. After a 15-second application, the surface is rinsed and dried, preparing it for dental adhesive application. The device facilitates proper bonding of dental adhesives to the tooth structure.

Clinical Evidence

Bench testing only. Five random subgroups with three samples each were tested by applying the gel to enamel surfaces for 15 seconds, followed by the application of a single-component adhesive. Results demonstrated that the adhesive cured effectively and achieved the desired bond strength.

Technological Characteristics

35% phosphoric acid solution. Ingredients: phosphoric acid, reagent grade water, FD&C coloring agents, xanthan gum. Form factor: gel for application via micro-brush, syringe, or pipette.

Indications for Use

Indicated for preparation of tooth surfaces prior to the application of dental adhesives in patients requiring dental restorative procedures.

Regulatory Classification

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.

Predicate Devices

Orthosource Etch Systems (K861245)

Related Devices

K200462 — EtchPro Etching Gel · Belport Company, Inc., Gingi-Pak · Sep 2, 2020
K152110 — e-1 etchants · E Dental Products · Nov 20, 2015
K131248 — ETCH GEL · Dmg America, LLC · Jul 11, 2013
K150696 — Jade 37% Phosphoric Acid Etchant Gel · Dharma Research, Inc. · Jun 23, 2015
K112597 — SEITY 37% PHOSPHORIC ACID ETCHANT GEL · Mycone Dental Supply Co., Inc. · Dec 7, 2011

Submission Summary (Full Text)

{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. {2}------------------------------------------------ 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. Page 3S {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 {6}------------------------------------------------ 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 {7}------------------------------------------------ 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)