FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PAPER POINTS
K Number: K830115
·
Decision Mar 1, 1983
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
22
Applicant Total
11
Review Days
49
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PAPER POINTS
- K Number
- K830115
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3850
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- North Pacific Dental, Inc.
- Date Received
- January 11, 1983
- Decision Date
- March 1, 1983
- Product Code
- EKM
- 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 |
|---|---|---|---|
| EKM | Gutta-Percha | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EKM), ordered by most recent decision date.
EI DOWNPAK BARRIER SLEEVES
FDA 510(k)
FDA Class 1
·Dental
DOWN PAK
FDA 510(k)
FDA Class 1
·Dental
TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE)
FDA 510(k)
FDA Class 1
·Dental
ENDO TWINN
FDA 510(k)
FDA Class 1
·Dental
FIBERFILL SGP
FDA 510(k)
FDA Class 1
·Dental
ANTIBACTERIAL GUTTA PERCHA
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by North Pacific Dental, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K830113 | SEPTOPACK | May 9, 1983 | Substantially Equivalent |
| K830111 | SEPTOCAL | Mar 24, 1983 | Substantially Equivalent |
| K830106 | UNICIDE | Mar 7, 1983 | Substantially Equivalent |
| K830109 | CIMPAT | Mar 1, 1983 | Substantially Equivalent |
| K830117 | ENDOMET | Mar 1, 1983 | Substantially Equivalent |
| K830105 | VITATHYL | Mar 1, 1983 | Substantially Equivalent |
| K830114 | GUTTA PERCHA POINTS | Mar 1, 1983 | Substantially Equivalent |
| K830107 | SELFAST | Feb 18, 1983 | Substantially Equivalent |
| K830116 | SULCARINGS | Feb 18, 1983 | Substantially Equivalent |
| K830112 | HYDROL | Feb 18, 1983 | Substantially Equivalent |