FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OTOMIMIX
K Number: K042516
·
Decision Nov 8, 2004
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
5
Applicant Total
56
Review Days
53
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
- OTOMIMIX
- K Number
- K042516
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Walter Lorenz Surgical, Inc.
- Date Received
- September 16, 2004
- Decision Date
- November 8, 2004
- Product Code
- NEA
- Advisory Committee
- Dental
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| NEA | Cement, Ear, Nose And Throat | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NEA), ordered by most recent decision date.
PROCEM
FDA 510(k)
FDA Class 2
·Dental
ENVOYCEM, MODEL 1640
FDA 510(k)
FDA Class 2
·Dental
STRYKER INJECTABLE CEMENT
FDA 510(k)
FDA Class 2
·Dental
OTO-CEM
FDA 510(k)
FDA Class 2
·Dental
SERENOCEM, MODEL BC 010
FDA 510(k)
FDA Class 2
·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 |
| 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 |
| K032228 | LORENZ 2.4 SELF DRILLING SCREWS | Aug 11, 2003 | Substantially Equivalent |