← Product Code [ELW](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELW) · K970129 # TULIP (K970129) _Richard Ting · ELW · Aug 18, 1997 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELW/K970129 ## Device Facts - **Applicant:** Richard Ting - **Product Code:** [ELW](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELW.md) - **Decision Date:** Aug 18, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3660 - **Device Class:** Class 2 - **Review Panel:** Dental ## Indications for Use THE DENTAL ALGINATE IMPRESSION MATERIAL IS USED TO TAKE THE PATIENT'S IMPRESSIONS OF TEETH AND GUM WHEN THE PATIENT NEEDS DENTURE, PARTIAL, OR ANY KINDS OF DENTAL APPLIANCES AND ORTHODONTIC APPLIANCES. ## Device Story Dental alginate impression material; used by dental professionals to capture anatomical impressions of teeth and gums. Material mixed to create moldable paste; placed in impression tray; inserted into patient's mouth to set. Once set, removed to create negative replica of oral structures. Used for fabrication of dentures, partials, and orthodontic appliances. Provides physical model for dental laboratory or clinical use; facilitates custom fit of dental prosthetics. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Alginate-based dental impression material. Powder form requiring mixing with water to form a hydrocolloid gel. Standard dental impression material composition. ## 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} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Richard Ting 1510 South Broad Street Philadelphia, Pennsylvania 19146 Re: K970129 Trade Name: Tulip Regulatory Class: II Product Code: ELW Dated: June 27, 1997 Received: July 2, 1997 AUG 18 1997 Dear Mr. Ting: 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 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices. General regulation (21 CFR Part 820) 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 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 {1} Page 2 - Mr. Ting through 542 of 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2} 510(k) Number (if known): K970129 Device Name: DENTAL ALGINATE IMPRESSION MATERIAL Indications For Use: THE DENTAL ALGINATE IMPRESSION MATERIAL IS USED TO TAKE THE PATIENT'S IMPRESSIONS OF TEETH AND GUM WHEN THE PATIENT NEEDS DENTURE, PARTIAL, OR ANY KINDS OF DENTAL APPLIANCES AND ORTHODONTIC APPLIANCES. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number K970129 Prescription Use 20 (Per 21 CFR 801.109) OR Over-The-Counter Use No (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELW/K970129](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELW/K970129) **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