FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KIS-III NON-SUBMERGED IMPLANT, SCREWS AND CYLINDERS
K Number: K961381
·
Decision Sep 9, 1997
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
7
Review Days
539
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
- KIS-III NON-SUBMERGED IMPLANT, SCREWS AND CYLINDERS
- K Number
- K961381
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- The Emerging Technologies Group
- Date Received
- March 19, 1996
- Decision Date
- September 9, 1997
- 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 The Emerging Technologies Group
| K Number | Device Name | ||
|---|---|---|---|
| K961387 | MT-X | Sep 25, 1996 | Substantially Equivalent |
| K961386 | MT-2A | Sep 25, 1996 | Substantially Equivalent |
| K961384 | MT-2 | Sep 25, 1996 | Substantially Equivalent |
| K961385 | MT-3A | Sep 25, 1996 | Substantially Equivalent |
| K961382 | MT1A | Sep 25, 1996 | Substantially Equivalent |
| K961383 | MT1 | Sep 25, 1996 | Substantially Equivalent |