FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ABSORBENT POINTS
K Number: K761203
·
Decision Dec 13, 1976
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
6
Applicant Total
206
Review Days
6
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
- ABSORBENT POINTS
- K Number
- K761203
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3830
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Johnson & Johnson Professionals, Inc.
- Date Received
- December 7, 1976
- Decision Date
- December 13, 1976
- 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.
ABSORBENT ENDODONTIC POINT
FDA 510(k)
FDA Class 1
·Dental
ENDODONTIC PAPERPOINTS
FDA 510(k)
FDA Class 1
·Dental
ENDODONTIC PAPER POINTS
FDA 510(k)
FDA Class 1
·Dental
PREMIER ABSORBENT POINTS
FDA 510(k)
FDA Class 1
·Dental
R&R ABSORBENT POINTS
FDA 510(k)
FDA Class 1
·Dental
ENDODONTIC INSTRUMENTS
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by Johnson & Johnson Professionals, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K992173 | SIPHONGUARD CSF CONTROL DEVICE | Apr 7, 2000 | Substantially Equivalent |
| K991413 | CODMAN ETHISORB DURA PATCH | Mar 13, 2000 | Substantially Equivalent |
| K991222 | CODMAN MICROSENSOR VENTRICULAR CATHETER KIT | Jul 9, 1999 | Substantially Equivalent |
| K982379 | SUNDT SLIM-LINE ANEURYSM CLIP APPLIER | Dec 18, 1998 | Substantially Equivalent |
| K982812 | G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER) | Dec 4, 1998 | Substantially Equivalent |
| K983141 | CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS | Nov 6, 1998 | Substantially Equivalent |
| K983014 | SUMMIT ACETABULAR SYSTEM | Oct 27, 1998 | Substantially Equivalent |
| K980778 | HAKIM MICRO PROGRAMMABLE VALVE SYSTEM | Jul 17, 1998 | Substantially Equivalent |
| K974739 | HAKIM PROGRAMMABLE VALVE SYSTEM | Jul 1, 1998 | Substantially Equivalent |
| K980801 | J-FX BIPOLAR HEAD | May 29, 1998 | Substantially Equivalent |