Consulting Wallah › Device Explorer › Other devices › Orthodontic clasp, metal, preformed
Device Explorer · FDA GUDID · GMDN 35439

Orthodontic clasp, metal, preformed

A prefabricated dental device made of wrought metal alloy intended to retain and stabilize a removable orthodontic appliance to stationary teeth. It is manufactured to meet a standard specification for adaptation or direct insertion into the patient's mouth. T

US‑registered devices158in commercial distribution
Companies8labelers on GUDID
Single‑use94%of device records
Sterile0%labelled sterile
Prescription94%Rx‑only share
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Share of device records

Digital Dental Laboratories, Inc6742%
3M Unitek Corporation5736%
Hangzhou Dtc Medical Apparatus Co., Ltd.106%
Ortho Organizers, Inc.85%
Specialty Appliances, Llc74%
Dental Morelli Ltda64%
Orthometric - Industria E Comercio De Produtos Medicos E Odontologicos Ltda21%
G & H Wire Company, Inc.11%

Top labelers

CompanyDevicesShare
Digital Dental Laboratories, Inc6742%
3M Unitek Corporation5736%
Hangzhou Dtc Medical Apparatus Co., Ltd.106%
Ortho Organizers, Inc.85%
Specialty Appliances, Llc74%
Dental Morelli Ltda64%
Orthometric - Industria E Comercio De Produtos Medicos E Odontologicos Ltda21%
G & H Wire Company, Inc.11%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

DTCFLR Mesh L39mmFLR Mesh L38mmFLR Mesh L37mmFLR Mesh L36mmFLR Mesh L35mmFLR Mesh L34mmFLR Mesh L33mm3-way saggitalTransforce transverseTransforce sagittalTpa with acrylic padsTPA - Vert remTPA - hor remTPA - fixedTB Sag 2000

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

FDA product codes

CodeNameDevices
ECOSpring, Orthodontic67
ECNCLAMP, WIRE, ORTHODONTIC43
DZCWIRE, ORTHODONTIC20
DYJRetainer, Screw Expansion, Orthodontic9
EHPCLASP, PREFORMED8
DZDTube, Orthodontic6

GMDN & GCC registration

  • GMDN code 35439 · non‑implantable
  • Single‑use 94% · sterile 0% · Rx‑only 94% · 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

No structured size data on the register.

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

How many orthodontic clasp, metal, preformed products are registered in the US?

158 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthodontic clasp, metal, preformed", from 8 companies. The largest labeler is Digital Dental Laboratories, Inc with 42% of records.

Which FDA product codes apply?

ECO (Spring, Orthodontic), ECN (CLAMP, WIRE, ORTHODONTIC), DZC (WIRE, ORTHODONTIC), DYJ (Retainer, Screw Expansion, Orthodontic)

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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