← Product Code [ELW](/productcode/ELW) · K981091 # NEOCOLLOID, ORTHOPRINT (K981091) _Zhermack S.P.A. · ELW · May 21, 1998 · Dental · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K981091 ## Device Facts - **Applicant:** Zhermack S.P.A. - **Product Code:** [ELW](/productcode/ELW.md) - **Decision Date:** May 21, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3660 - **Device Class:** Class 2 - **Review Panel:** Dental ## Indications for Use Neocolloid and Orthoprint are alginate dental impression materials that are intended to be used to make dental impressions. The resulting impressions are used to make plaster models of the teeth. ## Device Story Neocolloid and Orthoprint are alginate-based dental impression materials. Used by dental professionals to capture anatomical details of teeth and oral structures. Material is mixed and placed in an impression tray; inserted into patient's mouth to set. Once set, the impression is removed and used to cast plaster models of the patient's dentition. Facilitates diagnostic and restorative dental procedures by providing accurate physical replicas of oral anatomy. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Alginate-based dental impression material. Formulated as a powder for mixing with water to form a gel. Physical properties consistent with standard dental alginate impression materials. ## Regulatory Identification Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures. ## Special Controls *Classification.* Class II (Special Controls). ## 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}------------------------------------------------ Image /page/0/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 three lines representing its wings and head. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ZHERMACK S.p.A. ·C/O Evan G. Dick, Ph.D E.G. Dick & Associates 7527 Westmoreland Avenue St. Louis, Missouri 63105 MAY 21 1998 Re : K981091 Neocolloid, Orthoprint Trade Name: Requlatory Class: II Product Code: ELW Dated: March 25, 1998 March 25, 1998 Received: Dear Dr. Dick: 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Page 320) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 {1}------------------------------------------------ Page 2 - Dr. Dick through 542 of the Act for devices under the Electronic Chrough 542 Or che not 10- 10- 10- 10- 10- other Federal laws or requlations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your six (i) privalence of your device to a legally marketed predicate device results in a classification for your marketed predice and thus, 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 regulation (== (============================================================================================================================================================= Additionally, for questions on Compliance at (301) 594-4692. compreation 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 Diredtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure ... . {2}------------------------------------------------ ## INDICATIONS FOR USE STATEMENT K981091 510(k) Number: Neocolloid and Orthoprint Device Names: Indications For Use: , - Neocolloid and Orthoprint are alginate dental impression materials that are intended to be used to make dental impressions. The resulting impressions are used to make plaster models of the teeth. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) ![Signature](signature) (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices | 510(k) Number | K981091 | |---------------|---------| |---------------|---------| | Prescription Use | Over-The-Counter Use | |----------------------|----------------------| | (per 21 CFR 801.109) | OR | (Optional Format 1-2-96) --- **Source:** [https://fda-staging.innolitics.com/device/K981091](https://fda-staging.innolitics.com/device/K981091) **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