# Zapalign Inc. (foreign exporter, Anyang-si Gyeonggi, KR): 20 new FDA device listings, incl. agent, tooth bonding, resin

**Score:** 55/100

| Field | Value |
|---|---|
| Establishment | Zapalign Inc. |
| Role | Foreign exporter |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device |
| Location | Anyang-si Gyeonggi, KR |
| New listings | 20 |
| Devices | Agent, Tooth Bonding, Resin; Material, Impression; Cement, Dental; Material, Tooth Shade, Resin; Crown And Bridge, Temporary, Resin; Bur, Surgical, General & Plastic Surgery; System, Skin Closure; Sealant, Pit And Fissure, And Conditioner; Zinc Oxide Eugenol; Set, Administration, Intravascular |
| Product codes | KLE, ELW, EMA, EBF, EBG, GFF, MKY, EBC, EMB, FPA, ELZ |
| Device classes | Class I, Class II |
| Medical specialties | Dental, General, Plastic Surgery, General Hospital |
| Brand names | AGENT, TOOTH BONDING, RESIN; MATERIAL, IMPRESSION; CEMENT, DENTAL; Material, tooth shade, resin; CROWN AND BRIDGE, TEMPORARY, RESIN; BUR, SURGICAL, GENERAL & PLASTIC SURGERY; SYSTEM, SKIN CLOSURE; ZINC OXIDE EUGENOL |
| First new listing | 2026-05-04 |
| Latest new listing | 2026-09-16 |
| FDA registration number | 3011944170 |
| Registration expires | 2026-12-31 |

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

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.