A hand-held manual dental instrument intended to be used for the application of a dental material (e.g., composite resin) to a dental prosthesis or to a patient’s tooth/teeth; the material is not included. It includes a handle with an application tip which hol
| Company | Devices | Share |
|---|---|---|
| Osung Mnd Co., Ltd. | 57 | 24% |
| Premier Dental Products Company | 34 | 14% |
| B& L Biotech, Inc. | 30 | 12% |
| Bmt Medizintechnik Gmbh | 19 | 8% |
| Hu-Friedy Mfg. Co., Llc | 17 | 7% |
| Clinician'S Choice Dental Products, Inc. | 14 | 6% |
| Micerium Spa | 13 | 5% |
| Den-Mat Holdings, Llc | 12 | 5% |
| American Medicals | 9 | 4% |
| Storz Am Mark Gmbh | 9 | 4% |
| Andre Gregate Braga Instrumentos Ltda | 6 | 2% |
| Goldendent | 5 | 2% |
Company = labeler of record on GUDID. 20 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 |
|---|---|---|
| EIY | Instrument, Filling, Plastic, Dental | 69 |
| DZN | INSTRUMENTS, DENTAL HAND | 48 |
| DZN | Instruments, Dental Hand | 35 |
| KXR | Applicator, Resin | 20 |
| EJB | Handle, Instrument, Dental | 15 |
| EIY | INSTRUMENT, FILLING, PLASTIC, DENTAL | 11 |
Use these as the dimensions to specify in a tender line.
242 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental material application tool, reusable", from 20 companies. The largest labeler is Osung Mnd Co., Ltd. with 24% of records.
EIY (Instrument, Filling, Plastic, Dental), DZN (INSTRUMENTS, DENTAL HAND), DZN (Instruments, Dental Hand), KXR (Applicator, Resin)
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.