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Device Explorer · FDA GUDID · GMDN 46536

Orthodontic anchoring screw

A small, metallic, implantable rod with a spiral thread and slotted/formed head that is inserted into the bone of the jaw to serve as a temporary anchor for an orthodontic device (e.g., a spring or plate). It is available in various sizes and lengths, and may

US‑registered devices2,227in commercial distribution
Companies33labelers on GUDID
Single‑use100%of device records
Sterile45%labelled sterile
Prescription75%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Microware Precision Co., Ltd.53024%
Dentos Inc.47221%
Jeil Medical Corporation38517%
Flower Orthopedics Corporation1878%
Ortholution Co.,Ltd.934%
Psm Medical Solutions733%
Ze Fang Technology Co., Ltd.542%
Biomaterials Korea, Inc.452%

Top labelers

CompanyDevicesShare
Microware Precision Co., Ltd.53024%
Dentos Inc.47221%
Jeil Medical Corporation38517%
Flower Orthopedics Corporation1878%
Ortholution Co.,Ltd.934%
Psm Medical Solutions733%
Ze Fang Technology Co., Ltd.542%
Biomaterials Korea, Inc.452%
Bomei Co., Ltd.422%
Kls-Martin L.P.342%
Ace Surgical Supply Co., Inc.321%
Gni Co.,Ltd301%

Company = labeler of record on GUDID. 33 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

MIS ORTHO ANCHOR SCREWInfinitas Orthodontic Mini ImplantBIO-RAY A-1 Anchor Screw SystemMico One Orthodontic ScrewOBS Anchorage ScrewBENEfitQuattroOrthoEasy®MediconVECTOR TASLEVEL ONE ORTHOANCHORRMO17mm Mini Screw Button Type15mm Mini Screw Button Type13mm Mini Screw Button Type11mm Mini Screw Button Type

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
OATImplant, Endosseous, Orthodontic1,580
DZEImplant, Endosseous, Root-Form288
HWCScrew, fixation, bone187
HRSPlate, fixation, bone187
OATImplant, endosseous, orthodontic121
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM54

GMDN & GCC registration

  • GMDN code 46536 · implantable
  • Single‑use 100% · sterile 45% · Rx‑only 75% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Outer Diameter (Millimeter) · 116Length (Millimeter) · 60Width (Millimeter) · 1

Use these as the dimensions to specify in a tender line.

How many orthodontic anchoring screw products are registered in the US?

2,227 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthodontic anchoring screw", from 33 companies. The largest labeler is Microware Precision Co., Ltd. with 24% of records.

Which FDA product codes apply?

OAT (Implant, Endosseous, Orthodontic), DZE (Implant, Endosseous, Root-Form), HWC (Screw, fixation, bone), HRS (Plate, fixation, bone)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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