Skip to content

Orthodaptic* Bonding Adhesive

by Johnson & Johnson Professionals, Inc. 510(k)

Active United States

510(k) K823851

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK823851 Date9 Jan 1983ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DYH
Device Class
Class II
Regulation
21 CFR Part 872.3750
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Other devices from Johnson & Johnson Professionals, Inc.

See all devices from Johnson & Johnson Professionals, Inc. →