FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL
K Number: K022675
·
Decision Nov 7, 2002
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
9
Review Days
87
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Basic Information
- Device Name
- PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL
- K Number
- K022675
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Prime Dental Manufacturing, Inc.
- Date Received
- August 12, 2002
- Decision Date
- November 7, 2002
- Product Code
- EBF
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | FDA class 2 | Dental |
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Other Clearances by Prime Dental Manufacturing, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K112574 | PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT | Jan 23, 2012 | Substantially Equivalent |
| K021524 | LIGHT CURE DENTAL DAM | Jul 19, 2002 | Substantially Equivalent |
| K013970 | PRIME-DENT HEMA DESENSITIZER | Feb 19, 2002 | Substantially Equivalent |
| K012794 | PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT | Nov 5, 2001 | Substantially Equivalent |
| K012761 | PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT | Nov 1, 2001 | Substantially Equivalent |
| K012673 | PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM | Oct 24, 2001 | Substantially Equivalent |
| K001108 | PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL | May 30, 2000 | Substantially Equivalent |
| K994224 | PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIAL | Jan 31, 2000 | Substantially Equivalent |