# Titanlinks Logistics LLC (repackager or relabeler, Newark, DE): 336 new FDA device listings, incl. scaler, ultrasonic

**Score:** 75/100

| Field | Value |
|---|---|
| Establishment | Titanlinks Logistics LLC |
| Owner / operator | TitanLinks Logistics LLC |
| Role | Repackager or relabeler |
| Establishment types | Repack or Relabel Medical Device |
| Location | Newark, DE, US |
| New listings | 336 |
| Devices | Scaler, Ultrasonic; Material, Tooth Shade, Resin; Varnish, Cavity; Sealant, Pit And Fissure, And Conditioner; Medical Glove, Specialty; Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs; Polymer Patient Examination Glove; Fentanyl And Other Opioid Protection Glove; Cement, Dental; Coating, Filling Material, Resin |
| Product codes | ELC, EBF, LBH, EBC, LZC, OPJ, LZA, QDO, EMA, EBD, KLE, ELW, HTD, EJB, EHJ |
| Device classes | Class I, Class II, Unclassified |
| Medical specialties | Dental, General Hospital, General, Plastic Surgery, Orthopedic, Ear, Nose, Throat, Radiology |
| Brand names | Air polish; dental spray; varnish; Pit & FIssure; Dental Filling; tooth resin; Glove; dental cement |
| First new listing | 2026-05-18 |
| Latest new listing | 2026-10-06 |
| FDA registration number | 3044819802 |
| Registration expires | 2027-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
- Listed in the last 45 days.

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.