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Refilit 1

by Majestic Drug Co., Inc.

Refilit 1 is a Class II device made by Majestic Drug Co., Inc., cleared under FDA 510(k) K964773 on 21 Feb 1997 and listed in FDA GUDID since 27 Jul 2016 (UDI-DI 00010705400883), active as of 23 Oct 2026. 2 FDA recalls are 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

2 ongoing

This device is named in the recall

Documents

510(k) K964773

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 Number00010705400883 UDI-DI Date27 Jul 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK964773 Date21 Feb 1997DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K964773 decided 21 Feb 1997 Active
  • FDA GUDID UDI-DI 00010705400883 listed 27 Jul 2016 Listed

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-0265-2024 FDA Class II initiated 4 Oct 2023

    Products were stored outside of labeled temperature requirements.

    • Ongoing Z-1529-2022 FDA Class II initiated 23 Jun 2022

    Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.

Timeline

4 dated events

  1. Cleared FDA 510(k) K964773
  2. Listed FDA GUDID 00010705400883
  3. Recall initiated FDA recalls Z-1529-2022
  4. Recall initiated FDA recalls Z-0265-2024

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Refilit
Generic name
Home-use dental cement
Model / reference
1
Primary DI / UDI-DI
00010705400883
510(k) Number
FDA product code
EMA
GMDN term
Home-use dental cement
Device class
Class II
Regulation number
872.3275
GUDID distribution status
In Commercial Distribution

Related devices

Category: Home-use dental cement

Cleared under the same submission (K964773)

Other devices from Majestic Drug Co., Inc.

  • Repair-It 1

    Class II

  • Recapit 1 Open recall

    Class II

  • Dentemp 1 Open recall

    Class II

  • DenTemp Custom 1

    Class I

See all devices from Majestic Drug Co., Inc. →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
Other properties (12, all answered No)