# H & H Co. (repackager or relabeler, Hayden, ID): 3 new FDA device listings, incl. handpiece, direct drive, ac-powered

**Score:** 65/100

| Field | Value |
|---|---|
| Establishment | H & H Co. |
| Owner / operator | W.H. Holden Inc. DBA H & H Company |
| Role | Repackager or relabeler |
| Establishment types | Repack or Relabel Medical Device |
| Location | Hayden, ID, US |
| New listings | 3 |
| Devices | Handpiece, Direct Drive, Ac-Powered; Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece; Drill, Bone, Powered |
| Product codes | EKX, ERL, DZI |
| Device classes | Class I, Class II |
| Medical specialties | Dental, Ear, Nose, Throat |
| First new listing | 2026-08-11 |
| Latest new listing | 2026-08-11 |
| FDA registration number | 2085199 |
| Registration expires | 2026-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.