A hand-held manual dental instrument intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient’s tooth/teeth; the restorative material is not included. It includes a handle with an application tip/brush which
| Company | Devices | Share |
|---|---|---|
| Premium Plus International Limited | 82 | 13% |
| Premium Plus (Dongguan) Limited | 68 | 11% |
| Young Microbrush, Llc | 63 | 10% |
| Vista Dental | 37 | 6% |
| Safco Dental Supply Co. | 35 | 5% |
| Plasdent Corporation | 33 | 5% |
| Reliance Orthodontic Products Inc | 33 | 5% |
| Centrix, Inc. | 31 | 5% |
| Hager Worldwide, Inc. | 16 | 2% |
| Unipack Medical Corporation | 13 | 2% |
| Den-Mat Holdings, Llc | 13 | 2% |
| Gc America Inc. | 11 | 2% |
Company = labeler of record on GUDID. 57 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| KXR | Applicator, Resin | 179 |
| KXR | APPLICATOR, RESIN | 163 |
| EJB | Handle, Instrument, Dental | 118 |
| KXF | Applicator, Absorbent Tipped, Non-Sterile | 29 |
| EJB | HANDLE, INSTRUMENT, DENTAL | 26 |
| DZN | Instruments, Dental Hand | 25 |
Use these as the dimensions to specify in a tender line.
644 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental material application tool, single-use", from 57 companies. The largest labeler is Premium Plus International Limited with 13% of records.
KXR (Applicator, Resin), KXR (APPLICATOR, RESIN), EJB (Handle, Instrument, Dental), KXF (Applicator, Absorbent Tipped, Non-Sterile)
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.