Implant, Endosseous, Orthodontic
Dental · 21 CFR 872.3640
It is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.
Recent MDR events
425 adverse event reports on file
- Palatal Implant ?4.1, L 4.2mmJul 27, 2026InjuryInstitut Straumann Ag0009613348-2026-011436
- PALATAL IMPLANT Ø4.1, L 4.2MMJul 3, 2026InjuryInstitut Straumann Ag0009613348-2026-010193
- PALATAL IMPLANT Ø4.1, L 4.2MMJun 29, 2026InjuryInstitut Straumann Ag0009613348-2026-009969
- SELF-DRILLING ANCHORAGE IMPL LB TI1.6X11Jun 29, 2026InjuryJjgc S.a.3008261720-2026-003361
- PALATAL IMPLANT Ø4.1, L 4.2MMJun 15, 2026InjuryInstitut Straumann Ag0009613348-2026-009061
- PALATAL IMPLANT Ø4.8, L 4.2MMMay 11, 2026InjuryInstitut Straumann Ag0009613348-2026-007094
- SELF-DRILLING ANCHORAGE IMPL MB TI 1.3X9Apr 27, 2026InjuryJjgc S.a.3008261720-2026-002088
- SELF-DRILLING ANCHORAGE IMPL MB TI 1.3X9Apr 27, 2026InjuryJjgc S.a.3008261720-2026-002088
- PALATAL IMPLANT Ø4.1, L 4.2MMApr 21, 2026InjuryInstitut Straumann Ag0009613348-2026-005982
- PALATAL IMPLANT Ø4.1, L 4.2MMApr 21, 2026InjuryInstitut Straumann Ag0009613348-2026-005989
Event type breakdown
Recalls
3 recall events for this product code
- Ormco/SybronendoTerminatedSep 12, 2013
Brand Name: Vector TAS 8mm Screw.
Ormco Corporation is voluntarily recalling one lot of 8 MM Vector TAS Screws because some screws of this lot were machined undersized at the top of the threads may potentially cause a weakening of the screw. Use of the undersized product may result in breakage of the screw during insertion or removal when torqued, possibly requiring surgical removal of any remaining pieces.
Z-2194-2013 · View FDA record ↗ - Straumann USA LLCTerminatedDec 4, 2007
Straumann Palatal Implant , 04.1 L 4.2 mm,
Sticking Transfer Piece: The Transfer Piece which accompanies the Palatal Implant may get stuck during implant requiring removal by using mechanical force.
Z-0277-2008 · View FDA record ↗ - Straumann USA LLCTerminatedDec 4, 2007
Straumann Palatal Implant , 4.8 L 4.2 mm,
Sticking Transfer Piece: The Transfer Piece which accompanies the Palatal Implant may get stuck during implant requiring removal by using mechanical force.
Z-0278-2008 · View FDA record ↗
Registered firms
77 firms currently registered for this product code
Bgs Beta-gamma-service Gmbh & Co Kg
Wiehl North Rhine-Westphalia, DE
Blue Sky Bio, Llc
Libertyville, IL, US
D B Orthodontics Ltd
WEST YORKSHIRE England, GB
Palaxa Precision Llc
Newport, MN, US
Bomei Co., Ltd.
Taoyuan City, TW
Jabil Inc. (monument)
Monument, CO, US
Specialty Appliances, Llc
CUMMING, GA, US
Unidade De Esterilizacao Cotia Ltda.
Cotia Sao Paulo, BR
Eurofins Inpac Medizintechnik Gmbh
Birkenfeld Baden-Wurttemberg, DE
Gni Co., Ltd
Hwaseong-si Gyeonggi, KR
Straumann Villeret Sa
VILLERET Bern, CH
Curitiba Esterilizacao De Materiais Medicos Ltda
Pinhais Parana, BR
Biomaterials Korea Inc.
Hanam-si Gyeonggi, KR
First Dental Supplies Llc
Winter Garden, FL, US
Zentek Medical Llc
Manalapan, NJ, US
Isomedix Operations, Inc
ONTARIO, CA, US
Jjgc Industria E Comercio De Materiais Dentarios Sa
Curitiba Parana, BR
Dentaurum Gmbh & Co. Kg
ISPRINGEN Baden-Wurttemberg, DE
Csy International Llc
Rancho Cucamonga, CA, US
Mk Meditech
Seongnam-si Gyeonggi, KR
Osteonic Co., Ltd.
Seoul, KR
Dental Morelli Ltda.
SOROCABA Sao Paulo, BR
Alfa Gate - Mazen Ltd.
kfar qara Northern, IL
Synthes (usa) Products Llc
West Chester, PA, US
510(k) clearances
52 clearances for this product code
- Bernhard Förster GmbH (Bernhard Foerster Ltd.)May 19, 2026
K260268 · OrthoEasy Pal; OrthoEasy Pal Long Neck
- Leone S.P.A.Jun 19, 2025
K242944 · Leone Orthodontic Implant TAD (Temporary Anchorage Device)
- Proimtech Saglik Urunleri Anonim SirketiSep 4, 2024
K231502 · Mini Screws
- Techwin Co., Ltd.Feb 8, 2024
K231913 · T-FIT
- Biomaterials Korea, Inc.Aug 21, 2023
K222245 · ACR Screw System
- Ze Fang Technology Co., Ltd.Oct 7, 2022
K202163 · Mico One Orthodontic Screw
- Craniofacial Technologies, Inc.Apr 28, 2022
K202691 · Ortholock Anchorage Devices
- Mk Meditech, Inc.Dec 19, 2021
K210559 · ATOZ Mini-Screw