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K Number
K973185
Device Name
AMERICAN DENTAL PRODUCTS HB-35 DESENSITIZER WITH FLUORIDE
Manufacturer
AMERICAN DENTAL PRODUCTS, INC.
Date Cleared
1997-11-14

(81 days)

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

HB-35 DESENSITIZER USE WITH FLUORIDE FOR SENSITIVE TEETH

Device Description

Not Found

AI/ML Overview

The provided text is for a 510(k) summary for a dental desensitizer product and does not contain the information requested about acceptance criteria or a study proving device performance in the context of an AI/human-in-the-loop system.

The document discusses:

  • A 510(k) summary for a dental desensitizer with fluoride (HB-35 Desensitizer with Fluoride).
  • Claims of comparable efficacy to other market brands based on "third-party testing" (without providing details of the testing).
  • Safety information related to its ingredients (Fluoride, Quals) and handling instructions.
  • The FDA's decision of substantial equivalence to pre-amendment devices, allowing it to be marketed.

Therefore, I cannot populate the table or provide the requested details because the information is not present in the given text. This submission is for a traditional medical device, not an AI-powered diagnostic or assistive technology.

§ 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.