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K Number
K172953
Device Name
Acid Etchant
Manufacturer
American Orthodontics
Date Cleared
2018-02-06

(133 days)

Product Code
KLE
Regulation Number
872.3200
Type
Traditional
Panel
DE
Reference & Predicate Devices
K152110
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Acid Etchant is a phosphoric acid etchant used for etching enamel and dentin to promote adhesion of primer/bonding agent adhesives to tooth structure and restorative materials.

Device Description

Acid Etchant is a phosphoric acid etchant used for etching enamel and dentin to promote adhesion of primer/bonding agent adhesives to tooth structure and restorative material. The Acid Etchant will be available in gel and liquid form. The gel form will be contained in syringes and the liquid form will be contained in dropper bottles. Applicator tips will be provided with the gel form. The Acid Etchant contains water, 37% phosphoric acid (CAS# 7664-38-2), silica and green dye. The silica is used as a thickener. The amount of silica will determine the flow behavior and viscosity of the Acid Etchant. The green dye is to provide contrast to the tooth's color. The combination of the flow behavior, delivery system and green dye provides and facilitates accurate and controlled application of the Acid Etchant during orthodontic treatment.

AI/ML Overview

The provided document describes a premarket notification (510(k)) for a dental device called "Acid Etchant." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for proving clinical performance through extensive comparative studies as would be seen for new, high-risk devices or AI-driven diagnostics.

Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving the device meets those criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone algorithm performance, or detailed ground truth establishment.

Instead, the submission focuses on non-clinical performance testing and comparison to a predicate device to demonstrate substantial equivalence.

Here's what can be extracted and why the other information is not present:

Key Findings from the Document:

  • Device Name: Acid Etchant

  • Predicate Device: E Dental Products e-1 Etchants (K152110)

  • Regulatory Class: Class II (Product Code KLE)

  • Indications for Use: "Acid Etchant is a phosphoric acid etchant used for etching enamel and dentin to promote adhesion of primer/bonding agent adhesives to tooth structure and restorative materials."

  • Clinical Performance Testing: "No clinical performance testing has been conducted." (Page 5-3, Section "Clinical Performance Testing")

  • Non-Clinical Performance Testing: The following tests were conducted:

    1. Performance Test in Accordance with ISO 29022:2013
    2. Viscosity Testing
    3. pH and Acid Content Testing
    4. Compatibility Testing

  • Basis for Substantial Equivalence:

    • Same intended use.
    • Same technological characteristics (delivery system, flow behavior, consistency, % Phosphoric Acid, pH, and similar materials).

  • Performance Data Reported (Non-Clinical Bench Testing):

    Device NameAverage Bond Strength [N/mm²]Viscosity (Pas):Calculated pH:% Phosphoric Acid:
    Acid Etchant (Gel)27.2010.81.637.5
    Acid Etchant (Liquid)26.910.541.637.6
    E Dental Products e-1 Etchants (Predicate)26.717-4.71.637*
    *Stated value from manufacturer

Explanation of Missing Information:

  1. Acceptance Criteria & Device Performance Table (as requested for clinical validation): The document does not provide clinical acceptance criteria because no clinical performance testing was conducted. The "performance data" table above reflects non-clinical bench testing comparing physical and chemical properties, not clinical outcomes or AI performance metrics.
  2. Sample Size for Test Set & Data Provenance: Not applicable, as no clinical test set was used for validating clinical performance or AI. The non-clinical tests would have their own sample sizes (e.g., number of bond strength tests), but these are not explicitly detailed in the summary beyond the reported averages.
  3. Number of Experts & Qualifications / Adjudication Method: Not applicable, as no human expert-based ground truth was established for a clinical or AI performance study.
  4. MRMC Comparative Effectiveness Study: No MRMC study was done, as explicitly stated "No clinical performance testing has been conducted." This device is a chemical etchant, not an AI or imaging diagnostic requiring human-in-the-loop evaluation.
  5. Standalone (Algorithm Only) Performance: Not applicable. This is a dental material, not an AI algorithm.
  6. Type of Ground Truth Used: For the non-clinical tests, the "ground truth" is laboratory measurement against specified standards (e.g., ISO 29022:2013 for bond strength, direct chemical measurements for pH and acid content). There is no "expert consensus" or "pathology" ground truth as would be used for diagnostic devices.
  7. Sample Size for Training Set & How Ground Truth for Training Set Was Established: Not applicable. This device is not an AI/ML product requiring training data.

In summary, this document is a 510(k) for a dental material (Acid Etchant), demonstrating substantial equivalence through non-clinical bench testing and material comparisons, not through clinical trials or AI performance evaluations that would involve the detailed criteria requested in the prompt.

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.