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Device Explorer · FDA GUDID · GMDN 31754

Orthodontic space maintainer

A dental prosthetic replacement for prematurely lost deciduous teeth intended to prevent closure of the space before eruption of the permanent successors. It is often an urgent necessity in the buccal segment to prevent impaction of the permanent teeth and oth

US‑registered devices299in commercial distribution
Companies9labelers on GUDID
Single‑use99%of device records
Sterile0%labelled sterile
Prescription34%Rx‑only share
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Share of device records

Denovo Dental, Inc.15251%
Kids-E-Dental Llp5017%
Nusmile, Ltd.4415%
Digital Dental Laboratories, Inc4013%
Rmo, Inc.62%
Five Star Orthodontic Laboratory & Supply Inc31%
Luxcreo Inc21%
Modern Dental Laboratory (Dg) Co., Ltd.10%

Top labelers

CompanyDevicesShare
Denovo Dental, Inc.15251%
Kids-E-Dental Llp5017%
Nusmile, Ltd.4415%
Digital Dental Laboratories, Inc4013%
Rmo, Inc.62%
Five Star Orthodontic Laboratory & Supply Inc31%
Luxcreo Inc21%
Modern Dental Laboratory (Dg) Co., Ltd.10%
Align Technology, Inc.10%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Orthodontic ApplianceRMO3DLuxCreo Clear Aligner SystemDistal Shoe Space MaintainerCrown & Loop Space MaintainerSingle Loop Space MaintainerInvisalign IPR Sub-AssemblySplint - Witzig/DenarSplint - SVED/Rick-a-natorSplint - RemedeezeSplint - Pivot ApplianceSplint - NTISplint - no claspsSplint - Night Appliance with Nasal DialatorSplint - Night Appliance

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

FDA product codes

CodeNameDevices
DYTMaintainer, Space Preformed, Orthodontic294
DYJRetainer, Screw Expansion, Orthodontic4
NXCAligner, Sequential2
DZCWire, Orthodontic1
DZPInstrument, Diamond, Dental1

GMDN & GCC registration

  • GMDN code 31754 · non‑implantable
  • Single‑use 99% · sterile 0% · Rx‑only 34% · 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 space maintainer products are registered in the US?

299 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthodontic space maintainer", from 9 companies. The largest labeler is Denovo Dental, Inc. with 51% of records.

Which FDA product codes apply?

DYT (Maintainer, Space Preformed, Orthodontic), DYJ (Retainer, Screw Expansion, Orthodontic), NXC (Aligner, Sequential), DZC (Wire, 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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