Advantage Dental Products, Inc.
4498 KLAIS DR., Clarkston, MI, US
Registered product codes
3 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 1833025.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Nov 16, 2023
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Nov 16, 2023
Postmarket Assurance: Devices · Citations posted
Inspection citations
7 on file
Top cited requirements
Compare to industry ↗21 CFR 820.25(b)Training - Lack of or inadequate procedures
121 CFR 820.30(g)Design validation - Risk analysis
121 CFR 820.30(j)Design history file
121 CFR 820.50Purchasing controls, Lack of or inadequate procedures
121 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
121 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
1
- 21 CFR 820.25(b)Nov 16, 2023
Training - Lack of or inadequate procedures
- 21 CFR 820.30(g)Nov 16, 2023
Design validation - Risk analysis
- 21 CFR 820.30(j)Nov 16, 2023
Design history file
- 21 CFR 820.50Nov 16, 2023
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.80(a)Nov 16, 2023
Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.90(a)Nov 16, 2023
Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.198(a)Nov 16, 2023
Lack of or inadequate complaint procedures
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.