Recognized standard
Standard No. 206-2024
FDA recognition 4-332 · ADA · Dental/ENT
Key facts
| Recognition number | 4-332 |
|---|---|
| Designation | Standard No. 206-2024 |
| Title | Implantable Materials for Bone Filling and Augmentation in Oral and Maxillofacial Surgery - Contents of a Technical File |
| Standards developer | American Dental Association |
| Specialty area | Dental/ENT |
| Date of entry | Dec 23, 2024 |
| Device classes | Class 2 |
| Scope (excerpt) | This standard applies to implantable materials used as dental devices for filling and augmenting bones in oral and maxillofacial surgery. Products that are essentially pure (>90 %) hydroxyapatite are not covered by this standard. Evaluation includes the physico-chemical, mechanical, biological, and… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: