← Product Code [EMA](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA) · K960910 # INDERMIL DENTAL (K960910) _Loctite Corp. · EMA · Mar 28, 1996 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K960910 ## Device Facts - **Applicant:** Loctite Corp. - **Product Code:** [EMA](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA.md) - **Decision Date:** Mar 28, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3275 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Indications for Use Indermil™ Dental is indicated for use as a dental cement for bonding dental materials, such as crowns, caps, and pins; or temporarily attaching a fiber to the surface of the tooth in a procedure to treat periodontal disease. ## Device Story Indermil™ Dental is a liquid n-butyl 2-cyanoacrylate adhesive; cures upon contact with anions. Used by dental professionals for bonding dental materials (crowns, caps, pins) or temporary fiber attachment for periodontal treatment. Supplied in high-density polyethylene dispensers; sterilized via gamma radiation. Provides mechanical fixation of dental components. ## Clinical Evidence Bench testing only; no clinical data provided. Equivalence established via comparative performance testing against predicate devices. ## Technological Characteristics Liquid n-butyl 2-cyanoacrylate adhesive. Sterilized by gamma radiation. Packaged in high-density polyethylene dispensers. Curing mechanism: anionic polymerization. ## 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 - OctyIdent® (CRX Medical) - Iso-Dent® (Ellman International Mfg., Inc.) ## 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} 510(k) Premarket Notification K 900910 MAR 28 1996 Appendix C 510(k) Summary of Safety and Effectiveness for Indermil™ Dental March 5, 1996 LOCTITE — Indermil® Dental {1} 510(k) Premarket Notification **Submitter:** Loctite Corporation 1001 Trout Brook Crossing Rocky Hill, Connecticut 06067 Telephone: 860-571-5284 **Date summary was prepared:** (Date of 510(k) clearance to be inserted) **Name of the device:** Indermil™ Dental **Identification of predicate devices:** OctyIdent® (CRX Medical, Raleigh, NC) Iso-Dent® (Ellman International Mfg., Inc., Hewlett, NY) **Description of the device:** Indermil™ Dental is liquid n-butyl 2-cyanoacrylate that cures in the presence of anions. Indermil™ Dental is sterilized by gamma radiation, and provided for use in high density polyethylene dispensers. **Intended Use:** Indermil™ Dental is indicated for use as a dental cement for bonding dental materials, such as crowns, caps, and pins; or temporarily attaching a fiber to the surface of the tooth in a procedure to treat periodontal disease. **Comparison of device characteristics to predicate devices:** Indermil™ Dental, OctyIdent®, and Iso-Dent® are all indicated for use in dental applications, including the bonding of dental materials, such as crowns, caps, and pins; or temporarily attaching a fiber to the surface of the tooth in a procedure to treat periodontal disease. The chemical compositions, n-butyl cyanoacrylate, octyl cyanoacrylate, and isobutyl cyanoacrylate, are equivalent, and test results further demonstrate that the two devices are equivalent in performance. **Conclusion:** It is therefore concluded that Indermil™ Dental is substantially equivalent to OctyIdent® and to Iso-Dent®. March 5, 1996 LOCTITE -- Indermil® Dental --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K960910](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EMA/K960910) **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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