FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEW OUTLINE
K Number: K023079
·
Decision Oct 30, 2002
Classifications
1
FEI Numbers
180
Registration Numbers
180
Same Product Code
188
Applicant Total
2
Review Days
44
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Basic Information
- Device Name
- NEW OUTLINE
- K Number
- K023079
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3770
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Anaxdent GmbH
- Date Received
- September 16, 2002
- Decision Date
- October 30, 2002
- Product Code
- EBG
- 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 |
|---|---|---|---|
| EBG | Crown And Bridge, Temporary, Resin | FDA class 2 | Dental |
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Other Clearances by Anaxdent GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K112044 | ANAXBLEND MODEL 20XXX (SEVERAL), ANAXGUM MODEL 25XXX (U), MOCK-UP DIRECT MODEL 240XXX (U), MOCK-UP DIRECT FLOW MODEL 24A | Jan 26, 2012 | Substantially Equivalent |