FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LC DENTAL HAND INSTRUMENT
K Number: K935217
·
Decision Jan 5, 1994
Classifications
1
FEI Numbers
99
Registration Numbers
99
Same Product Code
71
Applicant Total
2
Review Days
71
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Basic Information
- Device Name
- LC DENTAL HAND INSTRUMENT
- K Number
- K935217
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- L.C. Dental
- Date Received
- October 26, 1993
- Decision Date
- January 5, 1994
- Product Code
- EKJ
- 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 |
|---|---|---|---|
| EKJ | Burnisher, Operative | FDA class 1 | Dental |
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Other Clearances by L.C. Dental
| K Number | Device Name | ||
|---|---|---|---|
| K923384 | ANA 70 DISPERSED PHASE DENTAL ALLOY -- MODIFIED | Jan 11, 1993 | Substantially Equivalent |