A material primarily intended to be applied to a dental prosthesis (i.e., indirect restorative) and/or prosthesis component to promote bonding (e.g., to a composite resin cement, composite-based stain, or another prosthesis component). It may be referred to as
| Company | Devices | Share |
|---|---|---|
| Vista Dental | 11 | 19% |
| Bisco Inc. | 11 | 19% |
| Deltamed Gmbh | 5 | 9% |
| Darby Dental Supply, Llc | 5 | 9% |
| B.J.M. Laboratories Ltd | 4 | 7% |
| Kuraray Noritake Dental Inc. | 4 | 7% |
| Chameleon Dental Products, Inc | 4 | 7% |
| Bredent Gmbh & Co. Kg | 2 | 4% |
| Ivoclar Vivadent Aktiengesellschaft | 2 | 4% |
| Prismatik Dentalcraft, Inc | 2 | 4% |
| Premier Dental Products Company | 2 | 4% |
| Itena Clinical | 1 | 2% |
Company = labeler of record on GUDID. 16 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 |
|---|---|---|
| KLE | AGENT, TOOTH BONDING, RESIN | 21 |
| KLE | Agent, Tooth Bonding, Resin | 20 |
| EBC | SEALANT, PIT AND FISSURE, AND CONDITIONER | 12 |
| EBF | MATERIAL, TOOTH SHADE, RESIN | 7 |
| EBF | Material, Tooth Shade, Resin | 5 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 4 |
Use these as the dimensions to specify in a tender line.
57 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental prosthesis priming agent", from 16 companies. The largest labeler is Vista Dental with 19% of records.
KLE (AGENT, TOOTH BONDING, RESIN), KLE (Agent, Tooth Bonding, Resin), EBC (SEALANT, PIT AND FISSURE, AND CONDITIONER), EBF (MATERIAL, TOOTH SHADE, 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.