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ReminGel RGEL3000

by Vista Dental

ReminGel RGEL3000 is a Class II device made by Vista Dental, cleared under FDA 510(k) K241489 on 8 Jan 2025 and listed in FDA GUDID since 9 Oct 2025 (UDI-DI 10818207025064), active as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K241489

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 Number10818207025064 UDI-DI Date9 Oct 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK241489 Date8 Jan 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K241489 decided 8 Jan 2025 Active
  • FDA GUDID UDI-DI 10818207025064 listed 9 Oct 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K241489
  2. Listed FDA GUDID 10818207025064

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ReminGel
Generic name
Dental coating, tooth-desensitizing, home-use
Model / reference
RGEL3000
Primary DI / UDI-DI
10818207025064
510(k) Number
FDA product code
LBH
GMDN term
Dental coating, tooth-desensitizing, home-use
Device class
Class II
Regulation number
872.3260
GUDID distribution status
In Commercial Distribution

Other devices from Vista Dental

See all devices from Vista Dental →

Properties

  • Prescription use
  • Over-the-counter
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)