← Product Code [EMA](/productcode/EMA) · K990155 # HYDRO-CAST VERSA-TEMP NON-EUGENOL PROVISIONAL CEMENT, MODEL 70010 (K990155) _Kay See Dental Mfg. Co. · EMA · Feb 25, 1999 · Dental · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K990155 ## Device Facts - **Applicant:** Kay See Dental Mfg. Co. - **Product Code:** [EMA](/productcode/EMA.md) - **Decision Date:** Feb 25, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3275 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Indications for Use The eugenol free temporary dental cement is used to apply a temporary crown or bridge. It allows for an accurate seating, quick set, removal of excess material from work area , and a rigid set than can still be easily removed when the permanent is ready for application. ## Device Story Hydro-Cast Versa-Temp is a eugenol-free temporary dental cement dispensed via a syringe system. Used by dental professionals in clinical settings to seat temporary crowns and bridges. The material features a two-stage cure: an initial rubbery set for easy removal of excess material from tissues and undercuts, followed by a rigid final set for secure temporary retention. The cement is designed for easy removal when the permanent restoration is ready. Performance is verified through bench testing of initial and final set times under controlled humidity and temperature conditions. ## Clinical Evidence Bench testing only. Testing evaluated initial and final set times using 10 subgroups of three samples each at 75% humidity and 85°F. Initial set results ranged from 80-91 seconds (spec: 90s +/- 30s); final set results ranged from 175-196 seconds (spec: 3 min +/- 30s). ## Technological Characteristics Syringe-dispensed, eugenol-free dental cement. Composition: bis-GMA, multifunctional methacrylates, polymerization initiator/activator. Two-stage cure mechanism. Class II device. ## Regulatory Identification Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. ## Predicate Devices - UNTIL eugenol free temporary polymeric composition cementing agent ([K884081](/device/K884081.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 2/05/99 Ka990155 ## SUMMARY {1}------------------------------------------------ Date Prepared 01/15/99 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 Contact Clark Smith D.M.D. Page 2S {2}------------------------------------------------ Trade name - Hydro-Cast Versa-Temp Non-Eugenol Provisional Cement Common name - Temporary Cement Classification Name - Dental Cement (872.3275) Substantial equivalence claimed to - UNTIL eugenol free temporary polymeric composition cementing agent, K884081. Manufactured by SciPharm. Description of the device. The device is a syringe dispensing system that dispenses a eugenol free temporary dental cement Intended use of device. The eugenol free temporary dental cement is used to apply a temporary crown or bridge. It allows for an accurate seating, quick set, removal of excess material from work area , and a rigid set than can still be easily removed when the permanent is ready for application. Page 3S {3}------------------------------------------------ ## TECHNOLOGICAL CHARACTERISIC COMPARISON SciPharm UNTIL - 1. Base: Preparation of bis-GMA Multifunctional methacrylates, polymerization initiator. - 2. Catalyst: Preparation of bis-GMA, multifunctional methacrylates, polymerization initiator. Hydro-Cast Versa Temp Base: Preparation of bis-GMA Multifunctional methacrylates polymerization activator. Catalyst: Preparation of bis-GMA, multifunctional methacrylates, polymerization initiator. Summary: The technological characteristics of the two devices are identical. Page 4S {4}------------------------------------------------ ## Discussion NON-CLINICAL PERFORMANCE TESTING AND DATA The critical performance characteristics of Hydro-Cast Versa-Temp Non-Eugenol Provisional Cement are Initial Set and Final set. Kay-See Dental performed test to assure the product performed to specification. Specifications: Initial Set - 90 sec +/- 30 sec Final Set - 3 min +/- 30 sec Test procedure: Conditions - 75% humidity, 85 degree F Sampling - 10 random subgroups of three samples each The catalyst and base components were dispensed and mixed to obtain a .5 gram sample. Using an electronic stop watch, the samples were monitored for initial set ( rubbery consistency) and then for final set (hardened material). | Test results: | Initial Set | Final Set | |---------------|-------------|-----------| | Min | 80 sec | 175 sec | | Max | 91 sec | 196 sec | Conclusion: The results of this testing provides additional assurance that Hydro-Cast Versa-Temp Non-Eugenol Provisional Cement does provide the important two stage cure and its performance is substantially equivalent to the predicate device. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. In the center of the seal is an abstract image of an eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB 2 5 1999 Clark Smith, D.M.D. Executive Vice President Kay-See Dental Manufacturing Company 124 East Missouri Avenue Kansas City, Missouri 64106-1294 Re : K990155 Trade Name: Hydro-Cast Versa-Temp Non-Eugenol Provisional Cement Requlatory Class: II Product Code: EMA Dated: January 15, 1999 Received: January 19, 1999 Dear Dr. Clark 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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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. ਜੋ 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. Clark the Act for devices under the Electronic Product Ratiation the Act for devices ander on other Federal laws or regulations. This letter will allow you to begin marketing your device as Inis recei will arrowk) premarket notification. The FDA described in your 510\x) promatics of your device to a legally I marketed predicate device results in a classification for your marketed predicate device to proceed to the market. If you desire specific advice for your device on our labeling If you debire bpg 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 Compriance at (50) overtising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the office or compiland, "Misbranding by reference to the regulation entification" (21 CFR 807.97). Other general premation on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance oblained from chonomiser (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fpa.gov/cdrh/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 {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows a stylized, handwritten word that appears to be "KMOISS". The letters are bold and black, contrasting with the white background. The style of the writing is somewhat abstract, making it appear like a logo or a piece of graphic art. ## STATEMENT OF INDICATIONS FOR USE Hydro-Cast Versa-Temp Eugenol-Free Provisional Cement is used for temporarily Hydro-Cast Versa-Temp Dagonor P.C. I Versa-Temp provides for easy seating of the temporary, very fast first stage cure with an excellent consistency that allows the removal le telliporaly, very hast inst suge out what and cultular tissues and undercuts, and a rigid set combined with easy removal of the temporary. set combined with any, THEN... Clark Smith D.M.D. Clark Smith D.M.D Susan Pennr (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices K990154 510(k) Number _ **Prescription Use** (Per 21 CFR 801.109) --- **Source:** [https://fda-staging.innolitics.com/device/K990155](https://fda-staging.innolitics.com/device/K990155) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com