Premier Dental Products Co.
1710 Romano Dr, PLYMOUTH MEETING, PA, US
Registered product codes
101 product codes
Recent MDR events
7 on file
- NITROSPRAY PLUSMay 3, 2021Injury2511556-2020-00002
- NITROSPRAY PLUSDec 8, 2020Injury2511556-2020-00001
- UNI-PUNCHFeb 5, 2020Malfunction0002521453-2020-00001
- 3TJul 26, 2016Malfunction5821721
- PREMIERMay 14, 2010Other2511556-2010-00003
- ZPREMIERApr 7, 2010Other2511556-2010-00002
- PREMIER BIG EASY ULTRALITE GRACEY 11/12Dec 12, 2006Injury2511556-2006-00001
Recalls
17 on file
- Open, ClassifiedMar 21, 2025
The hardness not meeting the material specification and may cause the diamond bur to bend.
View FDA record ↗ - TerminatedNov 20, 2004
Cryogen can escape from canister through the seal ring
View FDA record ↗ - TerminatedNov 20, 2004
Cryogen can escape from canister through the seal ring
View FDA record ↗ - TerminatedSep 15, 2004
foreign objects (polishing stones) in the tubes
View FDA record ↗ - TerminatedSep 15, 2004
foreign objects (polishing stones) in the tubes
View FDA record ↗ - TerminatedSep 15, 2004
foreign objects (polishing stones) in the tubes
View FDA record ↗ - TerminatedSep 15, 2004
foreign objects (polishing stones) in the tubes
View FDA record ↗ - TerminatedSep 15, 2004
foreign objects (polishing stones) in the tubes
View FDA record ↗ - TerminatedSep 15, 2004
foreign objects (polishing stones) in the tubes
View FDA record ↗ - TerminatedSep 15, 2004
foreign objects (polishing stones) in the tubes
View FDA record ↗
Compliance history
Matched by FEI 2511556.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
2 on file
Top refusal reasons
Compare to industry ↗- Division of Northeast Imports (DNEI)Jul 10, 2026
76ELL \ TEETH, PORCELAIN
- Division of Northeast Imports (DNEI)Aug 19, 2024
76MVL \ CORD, RETRACTION