Prime Dental Manufacturing, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 9
- Inspections
- 4
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K112574 | PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT | January 23, 2012 |
| K022675 | PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL | November 7, 2002 |
| K021524 | LIGHT CURE DENTAL DAM | July 19, 2002 |
| K013970 | PRIME-DENT HEMA DESENSITIZER | February 19, 2002 |
| K012794 | PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT | November 5, 2001 |
| K012761 | PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT | November 1, 2001 |
| K012673 | PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM | October 24, 2001 |
| K001108 | PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL | May 30, 2000 |
| K994224 | PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIAL | January 31, 2000 |