Permaflo
510(k) K974413
Permaflo is a Class II device made by Ultradent Products, Inc., cleared under FDA 510(k) K974413 on 2 Feb 1998, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK974413 | Date2 Feb 1998 | StatusActive |
Official records
- FDA 510(k) database K974413
Recalls
-
- Terminated Z-0053-2021
Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.
Timeline
- Cleared FDA 510(k) K974413
- Recall initiated FDA recalls Z-0053-2021
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EBF
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3690
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K974413
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| PermaFlo 1273 | 1273 / 1273 | 00883205104113 | — | On the market |
| PermaFlo 956 | 956 / 956 | 00883205103871 | — | On the market |
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