| ISO 20795-2 Second edition 2013-03-01 Dentistry - Base polymers - Part 2: Orthodontic base polymers |
| Recognition Date | 2017-08-21 |
| Recognition List | 047 |
| Recognition Number | 4-233 |
| 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 part of ISO 20795 is applicable to orthodontic base polymers and copolymers used in the construction of both active and passive orthodontic appliances and specifies their requirements. It also specifies test methods to be used in determining compliance with these requirements. It further specifies requirements with respect to packaging and marking the products and to the instructions to be supplied for use of these materials.
| Regulation Number | Device Name | Device Class | Product Code |
| §872.5570 | Device, Anti-Snoring | Class 2 | LRK |
| §872.5570 | Device, Jaw Repositioning | Class 2 | LQZ |
| §872.5570 | Prelude Tongue Suspension System | Class 2 | ORY |
| §872.5525 | Maintainer, Space Preformed, Orthodontic | Class 1 | DYT |
| §872.5525 | Positioner, Tooth, Preformed | Class 1 | KMY |
| §872.5470 | Aligner, Sequential | Class 2 | NXC |
| §872.3760 | Resin, Denture, Relining, Repairing, Rebasing | Class 2 | EBI |
| Unclassified | Mouthguard, Migraine/Tension Headache | OCO | |
| Unclassified | Mouthguard, Over-The-Counter | OBR | |
| Unclassified | Mouthguard, Prescription | MQC | |
| Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA, issued November 12, 2002. |