| ISO 6874 Third edition 2015-09-01 Dentistry - Polymer-based pit and fissure sealants |
| Recognition Date | 2016-04-04 |
| Recognition List | 041 |
| Recognition Number | 4-222 |
| Extent | Complete standard |
| 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 International Standard specifies requirements and test methods for polymer-based materials intended for sealing pits and fissures in teeth.
This International Standard covers both self-curing and external-energy-activated materials.
| Regulation Number | Device Name | Device Class | Product Code |
| §872.3765 | Sealant, Pit And Fissure, And Conditioner | Class 2 | EBC |
| Guidance for Industry and FDA Staff Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions Document issued on: October 26, 2005 http://www.fda.gov/RegulatoryInformation/Guidances/ucm071576.htm |