← Product Code [ELW](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELW) · K952614 # JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL (K952614) _Dentsply Intl. · ELW · Aug 13, 1996 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELW/K952614 ## Device Facts - **Applicant:** Dentsply Intl. - **Product Code:** [ELW](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELW.md) - **Decision Date:** Aug 13, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3660 - **Device Class:** Class 2 - **Review Panel:** Dental ## Indications for Use JELTRATE PLUS is used for all routine dental impressions. ## Device Story Jeltrate PLUS is a dustless, fast-setting alginate impression material used by dental professionals to capture dental anatomy. The device functions as a physical impression medium. The subject of this submission is an antimicrobial claim: the material eliminates up to 99% of viable surface microorganisms following a 15-second water rinse of the impression. This feature aims to reduce cross-contamination risks for dental staff handling impressions prior to disinfection or laboratory processing. ## Clinical Evidence Bench testing only. Study results support the claim that the material eliminates up to 99% of viable surface microorganisms after a 15-second water rinse of the impression. ## Technological Characteristics Alginate-based dental impression material. Dustless, fast-setting formulation. No changes in composition, design, or manufacturing compared to predicate K883842. ## 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 - Jeltrate PLUS Impression Material ([K883842](/device/K883842.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} K952614 DENTSPLY International 570 West College Avenue P.O. Box 872 York, PA 17405-0872 (717) 845-7511 Fax (717) 854-2343 AUG 13 1996 COMPLIANCE DEPT. TELEFAX (717) 849-4343 August 8, 1996 301-480-3002 TELEFAXED AND EXPRESS MAIL Mr. Greg Singleton (HFZ-480) Food and Drug Administration Center for Devices and Radiological Health 9200 Corporate Boulevard Rockville, MD 20850 AMENDMENT #3 K952614, Jeltrate® PLUS™ Antimicrobial Dustless Alginate Impression Material This letter is in response to your telephone call to me this afternoon. As you requested, attached is a revised 510(k) SUMMARY for K952614, changing the claim to read: Jeltrate® PLUS™ eliminates up to 99% of viable surface microorganisms after water rinsing the impression for just 15 seconds. If you have any additional questions, please don't hesitate to contact me. Thank you. Sincerely, ![img-0.jpeg](img-0.jpeg) P. Jeffery Lehn Associate Director Corporate Compliance Attachment {1} DENTSPLY International 570 West College Avenue P.O. Box 872 York, PA 17405-0872 (717) 845-7511 Fax (717) 854-2943 510(k) SUMMARY NAME & ADDRESS: DENTSPLY International, 570 West College Avenue, York, PA 17404 CONTACT: P. Jeffery Lehn PHONE: (717) 845-7511 FAX: (717) 849-4343 DATE PREPARED: August 8, 1996 TRADE OR PROPRIETARY NAME: JELTRATE® PLUS™ IMPRESSION MATERIAL COMMON OR USUAL NAME: Impression Material CLASSIFICATION NAME: Impression Material, 21 CFR, 872.3660 LEGALLY MARKETED DEVICE: Jeltrate PLUS Impression Material K883842 DESCRIPTION OF DEVICE: JELTRATE PLUS is dust free, fast setting, and helps protect staff from infection due to cross-contamination prior to soaking the impression. INTENDED USE: JELTRATE PLUS is used for all routine dental impressions. TECHNOLOGICAL CHARACTERISTICS: There has been no change in composition, design, material, packaging, function or manufacture of Jeltrate® PLUS™ Antimicrobial Dustless Alginate Impression Material (K883842). This submission represents only an additional claim. We believe the conclusions of the study conducted support the additional claim that JELTRATE PLUS eliminates up to 99% of viable surface microorganisms after water rinsing the impression for just 15 seconds. --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELW/K952614](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/ELW/K952614) **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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