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Assure APP

by Reliance Orthodontic Products, Inc.

Assure APP is a Class II device made by Reliance Orthodontic Products, Inc., cleared under FDA 510(k) K895522 on 7 Dec 1989 and listed in FDA GUDID since 25 Jul 2016 (UDI-DI D798APP0), active as of 22 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 22 Oct 2026

Documents

510(k) K895522

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD798APP0 UDI-DI Date25 Jul 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK895522 Date7 Dec 1989DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K895522 decided 7 Dec 1989 Active
  • FDA GUDID UDI-DI D798APP0 listed 25 Jul 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K895522
  2. Listed FDA GUDID D798APP0

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Assure
Generic name
Orthodontic bracket adhesive
Model / Ref / Catalog
APP
Primary DI / UDI-DI
D798APP0
510(k) Number
FDA product code
DYH
GMDN term
Orthodontic bracket adhesive
Device class
Class II
Regulation number
872.3750
GUDID distribution status
In Commercial Distribution

Related devices

Category: Orthodontic bracket adhesive

Cleared under the same submission (K895522)

and 8 more cleared under K895522

Other devices from Reliance Orthodontic Products, Inc.

See all devices from Reliance Orthodontic Products, Inc. →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)