(94 days)
No
The summary describes a chemical composition (liquid containing HEMA, Fluoride, and Benzakonium Fluoride) and its intended use in dental procedures. There is no mention of AI, ML, image processing, or any computational analysis of data.
No
The device is indicated for dental restorative, hypersensitivity, cervical, and hygiene procedures, which are not typically considered therapeutic in the medical sense unless specifically aimed at disease treatment or symptom alleviation beyond general care. Its function is primarily in the context of dental restoration and sensitivity management rather than healing or treating a medical condition systemically.
No
Explanation: The device is indicated for dental restorative, hypersensitivity, cervical, and hygiene procedures, and treats sensitive teeth and exposed dentin. It is not described as identifying or diagnosing conditions.
No
The device description clearly states it is a "Hydrophilic liquid containing Hydroxyethyl- methacrylate (HEMA), Fluoride and Benzakonium Fluoride," which are physical substances, not software.
Based on the provided information, the Acquaseal Benz is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes procedures performed on the patient (dental restorative, hypersensitivity, cervical, and hygiene procedures) and applied to anatomical sites within the mouth (sensitive teeth, exposed dentin/cementum).
- Device Description: The device is a liquid applied directly to the patient's teeth/dentin.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVDs are typically used in a laboratory setting or point-of-care setting to analyze biological samples. The Acquaseal Benz is a dental material applied directly to the patient's teeth for therapeutic and protective purposes.
N/A
Intended Use / Indications for Use
The Acquaseal Benz is indicated for dental restorative, hypersensitivity, cervical, and hygiene procedures.
Product codes (comma separated list FDA assigned to the subject device)
LBH, KLE
Device Description
Hydrophilic liquid containing Hydroxyethyl-methacrylate (HEMA), Fluoride and Benzakonium Fluoride.
Indicated as a bonding agent for dental restoration.
Desensitizing; Mechanically occludes the dentinal tubules due to polymerization to decrease hypersensitivity. Applied with a cotton swab tipped device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
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