| ISO 17730 First edition 2014-11-01 Dentistry - Fluoride varnishes |
| Recognition Number | Dental/ENT |
| Recognition Date | 2019-01-14 |
| Recognition List | 051 |
| Recognition Number | 4-257 |
| Extent | Partial recognition. The following part(s) of the standard is (are) not recognized -Introduction, the sentence, "Fluoride varnishes are used in dentistry primarily for caries prevention" -Definition 3.2, fluoride varnish. |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Dental/ENT |
| FDA Tech | Michael Adjodha FDA/OMPT/CDRH/ODE/DAGID/DEDB 301-796-6276 michael.adjodha@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. This standard is recognized in part because it: Conflicts with an existing regulation. Intended use of caries prevention conflicts with intended use of the device in 21 CFR 872.3260; see Procode listing below. Therefore the excepted clauses do not satisfy a premarket requirement under the FD&C Act for caries prevention.
This International Standard specifies requirements and their test methods for total digestible fluoride content in dental varnishes containing fluoride, intended for use in the oral cavity directly on the outer surfaces of teeth and fillings. It also specifies the requirements for their packaging and labelling, including the instructions for use. This International Standard covers fluoride varnishes to be applied by dental health care workers.
| Regulation Number | Device Name | Device Class | Product Code |
| §872.3260 | Varnish, Cavity | Class 2 | LBH |
| There is no relevant guidance developed at this time. |