FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PREPAIR
K Number: K033215
·
Decision Jan 9, 2004
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
47
Applicant Total
11
Review Days
98
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Basic Information
- Device Name
- PREPAIR
- K Number
- K033215
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6080
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Danville Materials, Inc.
- Date Received
- October 3, 2003
- Decision Date
- January 9, 2004
- Product Code
- KOJ
- 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 |
|---|---|---|---|
| KOJ | Airbrush | FDA class 2 | Dental |
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|---|---|---|---|
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| K111876 | Z BOND, PRELUDE ONE | Sep 21, 2011 | Substantially Equivalent |
| K110642 | SILJETR SYSTEM | May 27, 2011 | Substantially Equivalent |
| K102753 | TURBO TEMP 3 | Feb 4, 2011 | Substantially Equivalent |
| K092912 | STARFILL 2B HV (HIGH VISCOSITY) ROCKCORE, MODEL: 90838 AND STARFILL 2B LV (LOW VISCOSITY), MODEL: 90150 | Dec 16, 2009 | Substantially Equivalent |
| K092319 | STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387 | Sep 16, 2009 | Substantially Equivalent |
| K090106 | PRELUDE ONE | Mar 31, 2009 | Substantially Equivalent |
| K040952 | PRELUDE | Jun 29, 2004 | Substantially Equivalent |
| K020760 | STARFLOW HV | May 3, 2002 | Substantially Equivalent |
| K012354 | SNOWPOST, SNOWLIGHT | Oct 10, 2001 | Substantially Equivalent |