← Product Code [ELW](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELW) · K970594 # KALGINATE IMPRESSION MATERIAL (K970594) _Teledyne Water Pik · ELW · Mar 31, 1997 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELW/K970594 ## Device Facts - **Applicant:** Teledyne Water Pik - **Product Code:** [ELW](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELW.md) - **Decision Date:** Mar 31, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3660 - **Device Class:** Class 2 - **Review Panel:** Dental ## Indications for Use The intended use of Kalginate ®, a Dental Alginate Impression Material, is to obtain impressions of the patient’s teeth and oral tissues. ## Device Story Powdered alginate-based material; mixed with water to form elastic gel; placed in oral cavity to capture impressions of teeth and oral tissues; used by dental professionals in clinical settings; provides physical mold for dental restorations or diagnostic models. ## Clinical Evidence Bench testing only. Accelerated shelf-life testing (3 months at 23°C and 40°C) demonstrated stability equivalent to the original formulation. Biocompatibility confirmed via hamster cheek pouch mucosal irritation histopathology study, showing the new pigment formulation is non-irritating. ## Technological Characteristics Powdered alginate impression material; contains alginate as primary gel-forming agent; modified with Red Pigment #38. Physical form: powder for aqueous mixing. Sterilization: not applicable (non-sterile). ## 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). ## Predicate Devices - Kalginate ® Impression Material (preamendment device) ## 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} K970594 # MAR 31 1997 ## Kalginate ® 510(K) SUMMARY ### 1. Name and Address of Applicant Teledyne Water Pik 1730 East Prospect Road Fort Collins, CO 80553-0001 **Contact Person** Michael J. Ryan **Telephone** _________________________ **FAX** (970) 221-8252      (970) 221-8662 Prepared on 7 Feb 1997 ### 2. Name of the Device **Classification Name** - Dental Impression Material. **Common Name** - Alginate Impression Material. **Trade Name** - Kalginate ® Impression Material. ### 3. Legally Marketed Device for Substantial Equivalence Determination The Company’s Kalginate ® Impression Material, a preamendment device. ### 4. Description of the Device Kalginate ® is a powdered material, that is mixed with water and placed in the patient’s oral cavity. It contains alginate, an essential gel forming material, that reacts with water to form an elastic material suitable for making impressions of the patient’s teeth and oral tissues. ### 5. Intended use of the device The intended use of Kalginate ®, a Dental Alginate Impression Material, is to obtain impressions of the patient’s teeth and oral tissues. {1} 8 ## 6. Material/Technological Characteristics The color pigment material for the Company’s Kalginate ® Impression Material, Valencia Orange, is changed to Red Pigment # 38. A specification sheet and a Material Safety Data Sheet are enclosed. ## 7. Performance data ### Performance Accelerated shelf life testing was conducted on a batch of the new Kalginate ® Impression Material. The batch was mixed and processed using Research and Development equipment. Test samples from the batch were aged for 3 months at 23° and 40° C. The elevated temperature represents a 2 year shelf life. A summary of the tests and the results is discussed in Appendix 4. The results show no stability difference between the new and old Kalginate ® Impression Material formulations. ### Biocompatibility Test results from a cheek Pouch Mucosal Irritation Histopathology Study indicates that the Kalginate ® formulation with the Red Pigment #38 is non-irritating to the cheek pouch mucosa of hamsters. --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELW/K970594](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELW/K970594) **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. 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