FEI 3000719964Initial importer
Pac-dent Inc.
670 Endeavor Cir, Brea, CA, US
MDR events3All time
Recalls0All time
Registered products83
Establishment typeRepackRepack or Relabel Medical Device
Registered product codes
83 product codes
Recent MDR events
3 on file
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3000719964.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Mar 12, 2026
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Mar 12, 2026
Postmarket Assurance: Devices · Citations posted
Inspection citations
2 on file
Top cited requirements
Compare to industry ↗- 21 CFR 830.310(b)Mar 12, 2026
GUDID Information required for unique device identification.
- ISO 13485:2016 Clause 7.4.1Mar 12, 2026
Records of supplier (re)evaluation, selection, and monitoring not maintained
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.