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Device Explorer · FDA GUDID · GMDN 47996

Orthodontic anchor plate

A small metallic plate that is implanted intraorally to serve as a temporary anchor for an orthodontic device (e.g., a spring). It is available in various sizes and lengths and is anchored to the jawbone with dedicated bone screws. It is used in a variety of o

US‑registered devices150in commercial distribution
Companies7labelers on GUDID
Single‑use100%of device records
Sterile2%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Medline Industries, Inc.6946%
Kls-Martin L.P.3926%
Ace Surgical Supply Co., Inc.139%
Biomet Microfixation, Inc107%
Neoortho Produtos Ortopédicos S/A.96%
Jeil Medical Corporation85%
Synthes Gmbh21%

Top labelers

CompanyDevicesShare
Medline Industries, Inc.6946%
Kls-Martin L.P.3926%
Ace Surgical Supply Co., Inc.139%
Biomet Microfixation, Inc107%
Neoortho Produtos Ortopédicos S/A.96%
Jeil Medical Corporation85%
Synthes Gmbh21%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

LEVEL ONE ORTHOANCHORANCHORAGE SYSTEMTRUFIX Bone Fixation SystemMedlineMEDLINE UNITEPENDINGMATRIXWAVELeforte System Bone Plate / GBR System Bone PlatGBR System Bone PlateNEOFACE

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

FDA product codes

CodeNameDevices
HWCScrew, fixation, bone69
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM50
OATImplant, endosseous, orthodontic29
JEYPlate, Bone17
JEYPLATE, BONE2

GMDN & GCC registration

  • GMDN code 47996 · implantable
  • Single‑use 100% · sterile 2% · Rx‑only 100% · 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

Length (Millimeter) · 13

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

How many orthodontic anchor plate products are registered in the US?

150 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthodontic anchor plate", from 7 companies. The largest labeler is Medline Industries, Inc. with 46% of records.

Which FDA product codes apply?

HWC (Screw, fixation, bone), DZE (IMPLANT, ENDOSSEOUS, ROOT-FORM), OAT (Implant, endosseous, orthodontic), JEY (Plate, 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.

How do I get quotes?

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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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