FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SALIBAG
K Number: K913168
·
Decision Sep 6, 1991
Classifications
1
FEI Numbers
124
Registration Numbers
124
Same Product Code
7
Applicant Total
2
Review Days
51
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Basic Information
- Device Name
- SALIBAG
- K Number
- K913168
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.1905
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Nix Co. , Ltd.
- Date Received
- July 17, 1991
- Decision Date
- September 6, 1991
- Product Code
- EGZ
- 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 |
|---|---|---|---|
| EGZ | Holder, Film, X-Ray | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EGZ), ordered by most recent decision date.
ID-TAB
FDA 510(k)
FDA Class 1
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DENTAL X-RAY BITE BLOCK
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FDA Class 1
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TROLL-BITE
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EZX YELLOW, BLUE OR ORANGE
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S.S. WHITE DENTAL X-RAY FILM HOLDER & ALIGNING ARM
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FDA Class 1
·Dental
UNI-BITE DENTAL X-RAY FILM HOLDER
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by Nix Co. , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K913160 | ID-TAB | Sep 6, 1991 | Substantially Equivalent |