FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ENDODONTIC PAPER POINTS
K Number: K812886
·
Decision Nov 16, 1981
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
6
Applicant Total
5
Review Days
33
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Basic Information
- Device Name
- ENDODONTIC PAPER POINTS
- K Number
- K812886
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3830
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- United Dental Mfg., Inc.
- Date Received
- October 14, 1981
- Decision Date
- November 16, 1981
- Product Code
- EKN
- 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 |
|---|---|---|---|
| EKN | Point, Paper, Endodontic | FDA class 1 | Dental |
Similar 510(k) Clearances
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ENDODONTIC INSTRUMENTS
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Other Clearances by United Dental Mfg., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K843017 | ABSORBENT ENDODONTIC POINT | Jan 9, 1985 | Substantially Equivalent |
| K823686 | REAMER TYPE K ENDODONTIC | Dec 28, 1982 | Substantially Equivalent |
| K823685 | FILE TYPE H (HEDSTROEM) ENDODONTIC | Dec 28, 1982 | Substantially Equivalent |
| K823684 | FILE TYPE K ENDODONTIC | Dec 28, 1982 | Substantially Equivalent |