FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYS
K Number: K862523
·
Decision Aug 1, 1986
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
6
Applicant Total
56
Review Days
30
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
- MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYS
- K Number
- K862523
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Walter Lorenz Surgical, Inc.
- Date Received
- July 2, 1986
- Decision Date
- August 1, 1986
- Product Code
- EKW
- 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 |
|---|---|---|---|
| EKW | Broach, Endodontic | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EKW), ordered by most recent decision date.
DENTI-TRAY(TM)
FDA 510(k)
FDA Class 1
·Dental
CANNULATED INSTRUMENT CLEANERS
FDA 510(k)
FDA Class 1
·Dental
ENDODONTIC BROACH(76EKN) BARBED BROACH
FDA 510(k)
FDA Class 1
·Dental
ENDODONTIC BROACH-BARBED BROACH
FDA 510(k)
FDA Class 1
·Dental
ENDEX BROACH, ENDODONTIC
FDA 510(k)
FDA Class 1
·Dental
HAND INSTRUMENTS
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by Walter Lorenz Surgical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K063386 | LORENZ ORTHODONTIC ANCHORAGE SYSTEM | Feb 9, 2007 | Substantially Equivalent |
| K063052 | LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES | Jan 12, 2007 | Substantially Equivalent |
| K063506 | LORENZ STERNAL CLOSURE SYSTEM | Dec 18, 2006 | Substantially Equivalent |
| K062842 | TWIST DRILL | Dec 4, 2006 | Substantially Equivalent |
| K061384 | LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR STABILIZER, TITANIUM | Jun 6, 2006 | Substantially Equivalent |
| K042516 | OTOMIMIX | Nov 8, 2004 | Substantially Equivalent |
| K030425 | LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER | May 14, 2004 | Substantially Equivalent |
| K040990 | MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS | May 13, 2004 | Substantially Equivalent |
| K040983 | LORENZ SELF-DRILLING IMF SCREW | May 5, 2004 | Substantially Equivalent |
| K033740 | LORENZ STERNAL CLOSURE SYSTEM | Dec 15, 2003 | Substantially Equivalent |