← Product Code [EMA](/productcode/EMA) · K962065 # 3M VITREBOND LIGHT CURE GLASS IONOMER/BASE (K962065) _3M Company · EMA · Jul 18, 1996 · Dental · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K962065 ## Device Facts - **Applicant:** 3M Company - **Product Code:** [EMA](/productcode/EMA.md) - **Decision Date:** Jul 18, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3275 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Indications for Use 3M™ Vitrebond™ Light Cure Glass Ionomer Liner/Base is indicated for lining and basing applications under composite, amalgam, ceramic, and metal restorations. ## Device Story Two-component dental material (powder: light-sensitive fluoro-aluminosilicate glass; liquid: light-sensitive polyalkenoic acid); mixed and applied by dental professionals as liner/base under various restorations (composite, amalgam, ceramic, metal). Principle of operation: glass ionomer chemistry; bonds to tooth structure; releases fluoride; biocompatible. Light-cured via dental visible light curing unit; provides prolonged working time and rapid set time; enhanced mechanical/physical properties compared to auto-set liners. Benefits: improved clinical efficiency; protection of tooth structure under restorations. ## Clinical Evidence No clinical data; reliance on historical global usage data and toxicology/histology data from predicate K882821. ## Technological Characteristics Two-component system: light-sensitive fluoro-aluminosilicate glass powder and polyalkenoic acid liquid. Glass ionomer chemistry; light-cured polymerization. Biocompatible; fluoride-releasing. ## 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 - Vitrabond Light Cure Glass Ionomer Liner ([K882821](/device/K882821.md)) - Bisco Cavity Cleanser ([K915668](/device/K915668.md)) - Uni-Etch™ (part of One-Step Universal Dentin Adhesive) ## 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} 3M Dental Products Laboratory 3M Center, Building 260-2B-09 St. Paul, MN 55144-1000 612 733 3149 K962065 # 510(K) SUMMARY This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92. JUL 18 1996 Name: Amy E. Fowler Senior Regulatory Affairs Associate Address: 3M Dental Products Laboratory 3M Center, Building 260-2B-09 St. Paul, MN 55144-1000 Phone: (612) 736-1590 Fax: (612) 736-0990 Date: May 24, 1996 Trade Name: 3M™ Vitrebond™ Light Cure Glass Ionomer Liner/Base Common Names: cavity liner, lining cement, bonded base Classification Name: dental cement other than zinc oxide-eugenol (21 CFR 872.3275(b)) Predicate devices: Vitrabond Light Cure Glass Ionomer Liner (K882821) Bisco Cavity Cleanser (K915668) Uni-Etch™ (part of One-Step Universal Dentin Adhesive) 3M™ Vitrebond™ Light Cure Glass Ionomer Liner/Base is comprised of a powder and a liquid component. The powder component is a light sensitive fluoro-aluminosilicate glass. The liquid component is a light sensitive polyalkenoic acid. The composition is a true glass ionomer exhibiting the major characteristics of glass ionomer products - it bonds to tooth structure, releases fluoride, and is a biocompatible material. Additionally, Vitrebond liner/base offers the unique combination of a prolonged working time with a very short set time achieved by exposure to light from a dental visible light curing unit. Polymerization by light exposure not only eliminates the set time waiting period common to auto set liners, it also provides enhanced mechanical and physical properties. 3M™ Vitrebond™ Light Cure Glass Ionomer Liner/Base is indicated for lining and basing applications under composite, amalgam, ceramic, and metal restorations. 3M™ Vitrebond™ Light Cure Glass Ionomer Liner/Base has been changed very little since it was introduced globally over seven years ago. It is going through the 510(k) process now to add some labeling claims. In all other respects it is substantially equivalent to Vitrabond (K882821). The toxicology and histology data discussed in K882821 still applies, since the chemical composition is virtually unchanged. The fact that this material has been used globally for years with excellent results confirms the fact that this material is safe and effective for its intended uses. 3M™ Vitrebond™ Light Cure Glass Ionomer Liner/Base is substantially equivalent to the Bisco Cavity Cleanser (K915668) and Uni-Etch™ on the basis that they contact dentin and make a similar claim. --- **Source:** [https://fda-staging.innolitics.com/device/K962065](https://fda-staging.innolitics.com/device/K962065) **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