FDA.reportPublic FDA data

Fixed dental occlusal splint, custom-made

Definition
A rigid or flexible custom-made device intended to overlay the occlusal surfaces of the teeth to maintain the position of displaced or moveable teeth, typically in the perioperative period after trauma or orthognathic surgery (surgical orthodontics). It is fixed to the teeth with ligature wires by a clinician and is intended to remain in place short-term (
GUDID devices
12
Last updated
2026-11-01 02:54:53

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00888118142375IPSKLS-Martin L.P.60-500-28-09-LP2023-05-22
00888118142382IPSKLS-Martin L.P.60-500-29-09-LP2023-05-22
00888118142405IPSKLS-Martin L.P.60-500-31-09-LP2023-05-22
05420060351228TruMatch CMF Titanium 3D Printed SplintsMaterialise NVSD980.0302026-10-20
00888118155498IPSKLS-Martin L.P.60-500-15-092026-09-28
00888118155504IPSKLS-Martin L.P.60-500-15-09-LP2026-09-28
00888118155511IPSKLS-Martin L.P.60-500-15-09-PP2026-09-28
00888118155528IPSKLS-Martin L.P.60-500-17-092026-09-28
00888118155535IPSKLS-Martin L.P.60-500-17-09-LP2026-09-28
00888118155542IPSKLS-Martin L.P.60-500-18-092026-09-28
00888118155559IPSKLS-Martin L.P.60-500-18-09-LP2026-09-28
00888118155566IPSKLS-Martin L.P.60-500-30-09-LP2026-09-28