FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MACH 7
K Number: K990060
·
Decision Jun 15, 2000
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
47
Applicant Total
5
Review Days
524
Basic Information
- Device Name
- MACH 7
- K Number
- K990060
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6080
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- KREATIV, INC.
- Date Received
- January 8, 1999
- Decision Date
- June 15, 2000
- 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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Other Clearances by KREATIV, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K983227 | POWER BLOCK | Dec 11, 1998 | Substantially Equivalent |
| K980216 | KREATIV MACH 5, MACH 5 PLUS, MACH M, MACH 6 | Jun 16, 1998 | Substantially Equivalent |
| K962376 | KREATIV KURING LIGHT SYSTEM | Mar 21, 1997 | Substantially Equivalent |
| K940776 | KREATIV MODEL KV-1 | Dec 21, 1994 | Substantially Equivalent |