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Device Explorer · FDA GUDID · GMDN 38621

Mouthguard, reusable

A prefabricated oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during endoscopic diagnostic procedures, contact sports, and/or to prevent teeth grinding/clenching (bruxism). It is made of s

US‑registered devices86in commercial distribution
Companies31labelers on GUDID
Single‑use19%of device records
Sterile0%labelled sterile
Prescription31%Rx‑only share
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Share of device records

Dental Choice Holdings Llc3035%
Great Lakes Dental Technologies, Ltd.910%
Spiggle & Theis Medizintechnik Gmbh45%
1987 Media Limited33%
Grind Guard Technologies, L.L.C.33%
Plasdent Corporation33%
Young Innovations, Inc.33%
Walgreen Co.33%

Top labelers

CompanyDevicesShare
Dental Choice Holdings Llc3035%
Great Lakes Dental Technologies, Ltd.910%
Spiggle & Theis Medizintechnik Gmbh45%
1987 Media Limited33%
Grind Guard Technologies, L.L.C.33%
Plasdent Corporation33%
Young Innovations, Inc.33%
Walgreen Co.33%
Truer Medical, Inc.22%
Somatics, Llc22%
Meijer, Inc.22%
Ranir, Llc22%

Company = labeler of record on GUDID. 31 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ClenchNoMoreEXMOORTeeth protector, metalAESCULAPGrindRelief PROSmartGuardSmileSet Night GuardNylon Nightguard/Occlusal ApplianceQuickSplint Kit PouchOrofacial TherapeuticsPlasdentMouthGuardNight GuardDreamEZThe Orthodontic StoreGLO MOUTHGUARD BLACK (DZ) *

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

FDA product codes

CodeNameDevices
OBRMouthguard, Over-The-Counter54
DYJRetainer, Screw Expansion, Orthodontic7
MQCMouthguard, Prescription6
BRWProtector, dental4
BRWProtector, Dental3
DZDTUBE, ORTHODONTIC3

GMDN & GCC registration

  • GMDN code 38621 · non‑implantable
  • Single‑use 19% · sterile 0% · Rx‑only 31% · OTC 55%
  • 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.

No closely related category with 50+ devices.

How many mouthguard, reusable products are registered in the US?

86 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Mouthguard, reusable", from 31 companies. The largest labeler is Dental Choice Holdings Llc with 35% of records.

Which FDA product codes apply?

OBR (Mouthguard, Over-The-Counter), DYJ (Retainer, Screw Expansion, Orthodontic), MQC (Mouthguard, Prescription), BRW (Protector, dental)

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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