FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LORENZ SELF-DRILLING IMF SCREW
K Number: K040983
·
Decision May 5, 2004
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
56
Review Days
20
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
- LORENZ SELF-DRILLING IMF SCREW
- K Number
- K040983
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Walter Lorenz Surgical, Inc.
- Date Received
- April 15, 2004
- Decision Date
- May 5, 2004
- Product Code
- DZE
- 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 |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DZE), ordered by most recent decision date.
MegaGen Zygoma Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
INOSS System
FDA 510(k)
FDA Class 2
·Dental
Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant
FDA 510(k)
FDA Class 2
·Dental
Adin Long Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
ZENEX Implant System_Short (R-System)
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 |
| 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 |
| K033740 | LORENZ STERNAL CLOSURE SYSTEM | Dec 15, 2003 | Substantially Equivalent |
| K032228 | LORENZ 2.4 SELF DRILLING SCREWS | Aug 11, 2003 | Substantially Equivalent |