Who is the manufacturer of INDERMIL DENTAL?

Loctite Corp. submitted the Traditional clearance for INDERMIL DENTAL (K960910).

What is the FDA product code for INDERMIL DENTAL?

EMA. It is classified under 21 CFR 872.3275 as a Class 2 device in the Dental panel.

What is the regulatory pathway for INDERMIL DENTAL?

510(k) clearance (submission type: Traditional).

What are the predicate devices for INDERMIL DENTAL?

OctyIdent® (CRX Medical); Iso-Dent® (Ellman International Mfg., Inc.).

INDERMIL DENTAL

K960910 · Loctite Corp. · EMA · Mar 28, 1996 · Dental

Device Facts

Record ID	K960910
Device Name	INDERMIL DENTAL
Applicant	Loctite Corp.
Product Code	EMA · Dental
Decision Date	Mar 28, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3275
Device Class	Class 2
Attributes	Therapeutic

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.

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.

Indications for Use

Indicated for dental patients requiring bonding of dental materials (crowns, caps, pins) or temporary attachment of fibers to tooth surfaces for periodontal disease treatment.

Regulatory Classification

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.)

Related Devices

K974097 — PERIACRYL · Blacklock Medical Products, Inc. · Apr 9, 1998
K993556 — LIQUIBAND DENTAL · Medlogic Global Corp. · Jan 3, 2000
K071484 — PERIACRYL 90,80,70,60, MODEL9010, 8020, 7030, 6040 · Glustitch, Inc. · Oct 10, 2007
K013446 — GLUSITE, MODEL GLU002 · Glustitch, Inc. · Dec 20, 2001
K142130 — ORAL BOND · Steiner Laboratories · Jun 6, 2016

Submission Summary (Full Text)

{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