FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ORTHO WAX
K Number: K924024
·
Decision Nov 17, 1992
Classifications
1
FEI Numbers
198
Registration Numbers
198
Same Product Code
24
Applicant Total
145
Review Days
98
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Basic Information
- Device Name
- ORTHO WAX
- K Number
- K924024
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6890
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Heraeus Kulzer, Inc.
- Date Received
- August 11, 1992
- Decision Date
- November 17, 1992
- Product Code
- EGD
- 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 |
|---|---|---|---|
| EGD | Wax, Dental, Intraoral | FDA class 1 | Dental |
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| K030052 | OSTIM | Dec 6, 2004 | Substantially Equivalent |
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