Consulting Wallah › Device Explorer › Dental › Dental/maxillofacial surgical procedure kit, medic
Device Explorer · FDA GUDID · GMDN 45146

Dental/maxillofacial surgical procedure kit, medicated, single-use

A collection of various sterile dental/surgical instruments, dressings, pharmaceuticals and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. This is a single-use device.

US‑registered devices112in commercial distribution
Companies4labelers on GUDID
Single‑use100%of device records
Sterile98%labelled sterile
Prescription98%Rx‑only share
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Share of device records

Cardinal Health 200, Llc10997%
Altitude Technologies Inc.11%
North American Rescue, Llc11%
Aligned Medical Solutions11%

Top labelers

CompanyDevicesShare
Cardinal Health 200, Llc10997%
Altitude Technologies Inc.11%
North American Rescue, Llc11%
Aligned Medical Solutions11%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

TMM-DE (Tactical Medical Module-Dental)NAR KitAligned Medical SolutionsCARDINAL HEALTH

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

FDA product codes

CodeNameDevices
OFXGeneral purpose dental tray101
PWLOral Surgery Tray7
OFXGeneral Purpose Dental Tray2
OFXGeneral purpose dental tray (kit)1

GMDN & GCC registration

  • GMDN code 45146 · non‑implantable
  • Single‑use 100% · sterile 98% · Rx‑only 98% · OTC 1%
  • 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 dental/maxillofacial surgical procedure kit, medicated, single-use products are registered in the US?

112 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental/maxillofacial surgical procedure kit, medicated, single-use", from 4 companies. The largest labeler is Cardinal Health 200, Llc with 97% of records.

Which FDA product codes apply?

OFX (General purpose dental tray), PWL (Oral Surgery Tray), OFX (General Purpose Dental Tray), OFX (General purpose dental tray (kit))

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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