FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AIR TECHNIQUES' AIRDENT II
K Number: K981564
·
Decision Sep 24, 1998
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
47
Applicant Total
18
Review Days
146
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Basic Information
- Device Name
- AIR TECHNIQUES' AIRDENT II
- K Number
- K981564
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6080
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Air Techniques, Inc.
- Date Received
- May 1, 1998
- Decision Date
- September 24, 1998
- 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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