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PermaFlo 1273

by Ultradent Products, Inc.

PermaFlo 1273 is a Class II device made by Ultradent Products, Inc., cleared under FDA 510(k) K974413 on 2 Feb 1998 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00883205104113), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K974413

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00883205104113 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK974413 Date2 Feb 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K974413 decided 2 Feb 1998 Active
  • FDA GUDID UDI-DI 00883205104113 listed 22 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-0053-2021 FDA Class II initiated 31 Aug 2020

    Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.

Timeline

3 dated events

  1. Cleared FDA 510(k) K974413
  2. Listed FDA GUDID 00883205104113
  3. Recall initiated FDA recalls Z-0053-2021

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
PermaFlo
Generic name
Dental composite resin
Model / Ref / Catalog
1273
Primary DI / UDI-DI
00883205104113
510(k) Number
FDA product code
EBF
GMDN term
Dental composite resin
Device class
Class II
Regulation number
872.3690
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental composite resin

Similar devices in this category

Other devices filed under Dental composite resin.

Other devices from Ultradent Products, Inc.

See all devices from Ultradent Products, Inc. →

Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)