FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
R&R ABSORBENT POINTS
K Number: K781605
·
Decision Oct 10, 1978
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
6
Applicant Total
7
Review Days
22
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Basic Information
- Device Name
- R&R ABSORBENT POINTS
- K Number
- K781605
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3830
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Ransom and Randolph
- Date Received
- September 18, 1978
- Decision Date
- October 10, 1978
- 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
Other 510(k) clearances with the same product code (EKN), ordered by most recent decision date.
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ENDODONTIC PAPERPOINTS
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ENDODONTIC PAPER POINTS
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PREMIER ABSORBENT POINTS
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ABSORBENT POINTS
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ENDODONTIC INSTRUMENTS
FDA 510(k)
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Other Clearances by Ransom and Randolph
| K Number | Device Name | ||
|---|---|---|---|
| K780399 | INSTRUMENT CLEANING BRUSH | Mar 17, 1978 | Substantially Equivalent |
| K780199 | PROPHY ANGLES, R&R | Feb 16, 1978 | Substantially Equivalent |
| K780198 | PROPHY CUPS, R&R | Feb 16, 1978 | Substantially Equivalent |
| K771347 | R&R ALSTON CARBIDE BURS | Aug 3, 1977 | Substantially Equivalent |
| K770598 | ENDODONTIC INSTRUMENTS, R&R CUTWELL | Apr 5, 1977 | Substantially Equivalent |
| K761067 | DENTSPLY DIE STONE | Nov 30, 1976 | Substantially Equivalent |