FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TEMPOFIT, MODEL 02693
K Number: K994012
·
Decision Feb 16, 2000
Classifications
1
FEI Numbers
180
Registration Numbers
180
Same Product Code
188
Applicant Total
5
Review Days
82
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Basic Information
- Device Name
- TEMPOFIT, MODEL 02693
- K Number
- K994012
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3770
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Detax GmbH & Co. KG
- Date Received
- November 26, 1999
- Decision Date
- February 16, 2000
- 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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