FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FIXAFLOSS
K Number: K071615
·
Decision Sep 21, 2007
Classifications
1
FEI Numbers
93
Registration Numbers
93
Same Product Code
2
Applicant Total
106
Review Days
100
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Basic Information
- Device Name
- FIXAFLOSS
- K Number
- K071615
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6300
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sybron Dental Specialties, Inc.
- Date Received
- June 13, 2007
- Decision Date
- September 21, 2007
- Product Code
- EEF
- 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 |
|---|---|---|---|
| EEF | Clamp, Rubber Dam | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EEF), ordered by most recent decision date.
DISPOSABLE RADIOLUCENT RUBBER DAM CLAMP
FDA 510(k)
FDA Class 1
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BRINKER TISSUE RETRACTORS
FDA 510(k)
FDA Class 1
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