FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNIVERSAL FIX-A-PLATE
K Number: K833057
·
Decision Feb 27, 1984
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
6
Applicant Total
2
Review Days
173
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Basic Information
- Device Name
- UNIVERSAL FIX-A-PLATE
- K Number
- K833057
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3570
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Laurentian Laboratories
- Date Received
- September 7, 1983
- Decision Date
- February 27, 1984
- Product Code
- EBO
- 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 |
|---|---|---|---|
| EBO | Denture Repair Kit | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EBO), ordered by most recent decision date.
COMPLETE DENTURE REPAIR KIT
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DENTAL ORAL CARE SYSTEMS & COMPONENTS
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UNIVERSAL LINE-A-PLATE
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SAFE TDENT
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DENTURE ADJUSTMENT KIT
FDA 510(k)
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·Dental
EMERGENCY FAST-FIX DENTURE REPAIR KIT
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Laurentian Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K833056 | UNIVERSAL LINE-A-PLATE | Feb 27, 1984 | Substantially Equivalent |