Consulting Wallah › Device Explorer › Dental › Denture repair kit, professional
Device Explorer · FDA GUDID · GMDN 11171

Denture repair kit, professional

A collection of devices used in dentistry by a dentist or dental laboratory technician to repair cracks or breaks in a denture. It will contain the necessary materials and components, e.g., resins, adhesives/glues, mixing utensils, and an applicator. This is a

US‑registered devices53in commercial distribution
Companies4labelers on GUDID
Single‑use34%of device records
Sterile21%labelled sterile
Prescription64%Rx‑only share
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Share of device records

Harry J Bosworth Company2955%
Hygitech1121%
Ascend Eagle Incorporated815%
Keystone Industries59%

Top labelers

CompanyDevicesShare
Harry J Bosworth Company2955%
Hygitech1121%
Ascend Eagle Incorporated815%
Keystone Industries59%

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

Brand names on the register (sample)

HYGITECHBeesureMizzy MillenniumBosworth Duz-AllBosworth Duz-AllBosworth TruRepairBosworth Tru Repair

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

FDA product codes

CodeNameDevices
EBIRESIN, DENTURE, RELINING, REPAIRING, REBASING44
KDDKit, Surgical Instrument, Disposable9
EJBHandle, Instrument, Dental8
EIYInstrument, Filling, Plastic, Dental1
FXPCover, Shoe, Operating-Room1

GMDN & GCC registration

  • GMDN code 11171 · non‑implantable
  • Single‑use 34% · sterile 21% · Rx‑only 64% · 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

Weight (Gram) · 13Weight (Pound) · 12Weight (Kilogram) · 6Total Volume (Milliliter) · 5Total Volume (Fluid Ounce) · 5Total Volume (Liter) · 1

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

How many denture repair kit, professional products are registered in the US?

53 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Denture repair kit, professional", from 4 companies. The largest labeler is Harry J Bosworth Company with 55% of records.

Which FDA product codes apply?

EBI (RESIN, DENTURE, RELINING, REPAIRING, REBASING), KDD (Kit, Surgical Instrument, Disposable), EJB (Handle, Instrument, Dental), EIY (Instrument, Filling, Plastic, 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.

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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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