A substance intended exclusively for professional use in a healthcare facility and designed to be applied to exposed dentine (resulting from enamel erosion, breakage, tooth restoration procedure or gingival recession) to treat dental hypersensitivity caused by
| Company | Devices | Share |
|---|---|---|
| Ultradent Products, Inc. | 35 | 11% |
| Young Dental Manufacturing I, Llc | 35 | 11% |
| Kettenbach Gmbh & Co. Kg | 29 | 9% |
| Roses And Rubies, Llc | 22 | 7% |
| Gc America Inc. | 22 | 7% |
| Amd Medicom Inc | 21 | 7% |
| Elevate Oral Care, Llc | 16 | 5% |
| Ivoclar Vivadent Aktiengesellschaft | 14 | 4% |
| Voco Gmbh | 14 | 4% |
| Nusmile, Ltd. | 14 | 4% |
| Solventum Us Llc | 14 | 4% |
| Surgimac Llc | 8 | 2% |
Company = labeler of record on GUDID. 31 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 |
|---|---|---|
| LBH | Varnish, Cavity | 214 |
| LBH | VARNISH, CAVITY | 124 |
| KLE | AGENT, TOOTH BONDING, RESIN | 16 |
| EMA | CEMENT, DENTAL | 16 |
| PHR | Diammine Silver Fluoride Dental Hypersensitivity Varnish | 15 |
| KLE | Agent, Tooth Bonding, Resin | 10 |
Use these as the dimensions to specify in a tender line.
320 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental coating, tooth-desensitizing, professional", from 31 companies. The largest labeler is Ultradent Products, Inc. with 11% of records.
LBH (Varnish, Cavity), LBH (VARNISH, CAVITY), KLE (AGENT, TOOTH BONDING, RESIN), EMA (CEMENT, DENTAL)
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.