Dentonics, Inc.
2833 TOPHILL RD., MONROE, NC, US
Registered product codes
12 product codes
Recent MDR events
0 on file
No MDR events on file for this firm name.
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 1721647.
FDA inspections
2 on file
- Official Action Indicated (OAI)Sep 19, 2024
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Sep 19, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
6 on file
Top cited requirements
Compare to industry ↗21 CFR 820.181DMR - not or inadequately maintained
121 CFR 820.184DHR - not or inadequately maintained
121 CFR 820.30(j)Design history file
121 CFR 820.40Procedures not adequately established or maintained
121 CFR 820.50Purchasing controls, Lack of or inadequate procedures
121 CFR 820.75(a)Lack of or inadequate process validation
1
- 21 CFR 820.181Sep 19, 2024
DMR - not or inadequately maintained
- 21 CFR 820.184Sep 19, 2024
DHR - not or inadequately maintained
- 21 CFR 820.30(j)Sep 19, 2024
Design history file
- 21 CFR 820.40Sep 19, 2024
Procedures not adequately established or maintained
- 21 CFR 820.50Sep 19, 2024
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(a)Sep 19, 2024
Lack of or inadequate process validation
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.