(23 days)
Not Found
Not Found
No
The description focuses on the chemical composition and physical properties of the dental cement, with no mention of AI or ML.
Yes
The device is used to bond dental materials or temporarily attach a fiber to treat periodontal disease, which are therapeutic interventions.
No
Explanation: The device is described as a dental cement for bonding materials or temporarily attaching fibers, not for diagnosing any condition. Its intended use is therapeutic/restorative, not diagnostic.
No
The device description clearly states it is a liquid chemical (n-butyl 2-cyanoacrylate) provided in physical dispensers, indicating it is a physical substance and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for bonding dental materials and temporarily attaching fibers to teeth. This is a direct application to the patient's body for a therapeutic or restorative purpose.
- Device Description: The description details a liquid adhesive that cures in the presence of anions, used for bonding. This is a material used in a clinical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) to provide information about a physiological state, health, disease, or congenital abnormality.
IVDs are used in vitro (outside the body) to examine specimens from the human body. This device is used in vivo (within the body) as a dental cement.
N/A
Intended Use / 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.
Product codes
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Device Description
Indermil™ Dental is liguid n-butvl 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.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Octyldent® (CRX Medical, Raleigh, NC), Iso-Dent® (Ellman International Mfg., Inc., Hewlett, NY)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)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.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. 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.(2)
Classification. Class II.
0
MAr: 28 1356
:
Appendix C
510(k) Summary of Safety and Effectiveness for Indermil™ Dental
1
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)
Indermil™ Dental Name of the device:
Identification of predicate devices:
Octyldent® (CRX Medical, Raleigh, NC)
Iso-Dent® (Ellman International Mfg., Inc., Hewlett, NY)
Description of the device . Indermil™ Dental is liguid n-butvl 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, Octyldent®, and Iso-Dent® are all indicated for use in dental applications, including 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 Octyldent® and to Iso-Dent®.