FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
EXPLORER TIP
K Number: K823914
·
Decision Jan 21, 1983
Classifications
1
FEI Numbers
138
Registration Numbers
138
Same Product Code
2
Applicant Total
80
Review Days
24
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
- EXPLORER TIP
- K Number
- K823914
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Treace Medical, Inc.
- Date Received
- December 28, 1982
- Decision Date
- January 21, 1983
- Product Code
- EKB
- 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 |
|---|---|---|---|
| EKB | Explorer, Operative | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EKB), ordered by most recent decision date.
1410/1 TO 1435/13 VARIOUS PROBES & EXPLORERS
FDA 510(k)
FDA Class 1
·Dental
BEACH EXPLORER NO. 23T.G.
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by Treace Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K883727 | BUCKET PROSTHESIS PORP | Jan 13, 1989 | Substantially Equivalent |
| K882349 | MALLET, SURGICAL | Jun 23, 1988 | Substantially Equivalent |
| K874779 | BIPOLATOR 50 | Jan 29, 1988 | Substantially Equivalent |
| K873154 | TREACE MAGNUM OTO-TOOL SYSTEM | Sep 4, 1987 | Substantially Equivalent |
| K872000 | EYE GARD | Jul 21, 1987 | Substantially Equivalent |
| K870765 | CANNULATED INSTRUMENT CLEANERS | May 27, 1987 | Substantially Equivalent |
| K871706 | OPTHA PREP | May 18, 1987 | Substantially Equivalent |
| K870759 | CLEANING SOLUTION, CATALOG NO. 8203 | May 7, 1987 | Substantially Equivalent |
| K870766 | PROSTHESIS WIRE | Apr 15, 1987 | Substantially Equivalent |
| K870760 | BUR BRUSH | Mar 18, 1987 | Substantially Equivalent |