FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
X-TIP INTRAOSSEOUS PERFORATOR
K Number: K990511
·
Decision Apr 27, 1999
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
15
Applicant Total
15
Review Days
68
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Basic Information
- Device Name
- X-TIP INTRAOSSEOUS PERFORATOR
- K Number
- K990511
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4730
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Schiff & Co.
- Date Received
- February 18, 1999
- Decision Date
- April 27, 1999
- Product Code
- DZM
- 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 |
|---|---|---|---|
| DZM | Needle, Dental | FDA class 1 | Dental |
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