FDA.reportPublic FDA data

Orthodontic palate expander screw, bonded

Definition
An orthodontic device intended to be used as part of a bonded palate expander to gradually spread the maxillary arch to create space for teeth alignment. It is in the form of a threaded rod with expandable pins of various lengths; it is intended to remain in the oral cavity for the duration of treatment (fixed), and may be periodically adjusted by an orthodontist to affect skeletal and/or dental changes. This is a single-patient device intended to be used for the duration of treatment (single-use) before being discarded.
GUDID devices
115
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00840326409244The Orthodontic StoreYoung Innovations, Inc.620-0052022-11-02
00840326409251The Orthodontic StoreYoung Innovations, Inc.620-0062022-11-02
00840326409268The Orthodontic StoreYoung Innovations, Inc.620-0072022-11-02
00840326409275The Orthodontic StoreYoung Innovations, Inc.620-0122022-11-02
00840326409282The Orthodontic StoreYoung Innovations, Inc.620-2002022-11-02
00840326409299The Orthodontic StoreYoung Innovations, Inc.620-2112022-11-02
D775BMARPEL0MARPEGreat Lakes Dental Technologies, Ltd.BMARPEL2026-05-10
D775BMARPEP0MARPEGreat Lakes Dental Technologies, Ltd.BMARPEP2026-05-10
J011602806320N.A.DENTAURUM GmbH & Co.KG602-806-322021-12-04
J011602806330N.A.DENTAURUM GmbH & Co.KG602-806-332021-12-04
J011602809320N.A.DENTAURUM GmbH & Co.KG602-809-322021-12-04
J011602809330N.A.DENTAURUM GmbH & Co.KG602-809-332021-12-04
J011602815320N.A.DENTAURUM GmbH & Co.KG602-815-322021-12-04
J011602815330N.A.DENTAURUM GmbH & Co.KG602-815-332021-12-04
J011602819320N.A.DENTAURUM GmbH & Co.KG602-819-322021-12-04
J011602819330N.A.DENTAURUM GmbH & Co.KG602-819-332021-12-04
J011602836320N.A.DENTAURUM GmbH & Co.KG602-836-322021-12-04
J011602836330N.A.DENTAURUM GmbH & Co.KG602-836-332021-12-04
J011602837320N.A.DENTAURUM GmbH & Co.KG602-837-322021-12-04
J011602837330N.A.DENTAURUM GmbH & Co.KG602-837-332021-12-04
J011602838320N.A.DENTAURUM GmbH & Co.KG602-838-322021-12-04
J011602838330N.A.DENTAURUM GmbH & Co.KG602-838-332021-12-04
J011602839320N.A.DENTAURUM GmbH & Co.KG602-839-322021-12-04
J011602839330N.A.DENTAURUM GmbH & Co.KG602-839-332021-12-04
J011602845310N.A.DENTAURUM GmbH & Co.KG602-845-312021-11-30
J011602845330N.A.DENTAURUM GmbH & Co.KG602-845-332021-11-30
J011602845550N.A.DENTAURUM GmbH & Co.KG602-845-552021-11-30
J011602846310N.A.DENTAURUM GmbH & Co.KG602-846-312021-11-30
J011602846330N.A.DENTAURUM GmbH & Co.KG602-846-332021-11-30
J011602846550N.A.DENTAURUM GmbH & Co.KG602-846-552021-11-30
J011602847310N.A.DENTAURUM GmbH & Co.KG602-847-312021-11-30
J011602847330N.A.DENTAURUM GmbH & Co.KG602-847-332021-11-30
J011602847550N.A.DENTAURUM GmbH & Co.KG602-847-552021-11-30
J011902815500N.A.DENTAURUM GmbH & Co.KG602-815-502018-03-10
J01825242VECTOR® ScrewScheu-Dental GmbH2524.22024-11-18
J01825262VECTOR® ScrewScheu-Dental GmbH2526.22024-11-18
09120074342118PowerScrew 12Tiger Dental GmbH109652026-02-06
09120074342125PowerScrew 16Tiger Dental GmbH109672026-02-06
09120074342323PowerScrew 08Tiger Dental GmbH110112026-02-06
09120074343443PowerScrew 14Tiger Dental GmbH182152026-02-06
09120074343467PowerScrew 10Tiger Dental GmbH182222026-02-06
J01825240VECTOR® ScrewScheu-Dental GmbH2524.22024-11-18
J01825241VECTOR® ScrewScheu-Dental GmbH2524.12024-11-18
J01825260VECTOR® ScrewScheu-Dental GmbH2526.22024-11-18
J01825261VECTOR® ScrewScheu-Dental GmbH2526.12024-11-18
00889989088038Wilson 3D ApplianceALLESEE AOA-PRO3000-00552023-04-05
00889989088045Bi-HelixALLESEE AOA-PRO3000-00542023-04-05
00889989088052W Arch ExpanderALLESEE AOA-PRO3000-00532023-04-05
00889989088069Arnold ExpanderALLESEE AOA-PRO3000-00522023-04-05
00889989088076FrozatALLESEE AOA-PRO3000-00492023-04-05
00889989088083Fan ExpanderALLESEE AOA-PRO3000-00482023-04-05
00889989038644Rapid Palatal ExpanderALLESEE AOA-PRO3000-00402023-03-13
00889989038651Quad HelixALLESEE AOA-PRO3000-00412023-03-13
00889989038668Lower ExpanderALLESEE AOA-PRO3000-00422023-03-13
00889989038699DeLuke Bonded Frameless ExpanderALLESEE AOA-PRO3000-00452023-03-13
00889989038705Haas ExpanderALLESEE AOA-PRO3000-00462023-03-13
D8199001950Mini-Palex Screw 12mmSPECIALTY APPLIANCES, LLC9001952022-11-18
10840326409241The Orthodontic StoreYoung Innovations, Inc.620-0052022-11-02
10840326409258The Orthodontic StoreYoung Innovations, Inc.620-0062022-11-02
10840326409265The Orthodontic StoreYoung Innovations, Inc.620-0072022-11-02
10840326409272The Orthodontic StoreYoung Innovations, Inc.620-0122022-11-02
10840326409289The Orthodontic StoreYoung Innovations, Inc.620-2002022-11-02
10840326409296The Orthodontic StoreYoung Innovations, Inc.620-2112022-11-02
J011607126300N.A.DENTAURUM GmbH & Co.KG607-126-302018-05-05
J011607126320N.A.DENTAURUM GmbH & Co.KG607-126-322018-05-05
J011607126400N.A.DENTAURUM GmbH & Co.KG607-126-402018-05-05
J011607126420N.A.DENTAURUM GmbH & Co.KG607-126-422018-05-05
J011602834120HyraxDENTAURUM GmbH & Co.KG602-834-122022-06-21
J011602806120N.A.DENTAURUM GmbH & Co.KG602-806-122021-12-04
J011602806130N.A.DENTAURUM GmbH & Co.KG602-806-132021-12-04
J011602806321N.A.DENTAURUM GmbH & Co.KG602-806-322021-12-04
J011602806331N.A.DENTAURUM GmbH & Co.KG602-806-332021-12-04
J011602809120N.A.DENTAURUM GmbH & Co.KG602-809-122021-12-04
J011602809130N.A.DENTAURUM GmbH & Co.KG602-809-132021-12-04
J011602809321N.A.DENTAURUM GmbH & Co.KG602-809-322021-12-04
J011602809331N.A.DENTAURUM GmbH & Co.KG602-809-332021-12-04
J011602815120N.A.DENTAURUM GmbH & Co.KG602-815-122021-12-04
J011602815130N.A.DENTAURUM GmbH & Co.KG602-815-132021-12-04
J011602815321N.A.DENTAURUM GmbH & Co.KG602-815-322021-12-04
J011602815331N.A.DENTAURUM GmbH & Co.KG602-815-332021-12-04