FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STARTANIUS DENTAL IMPLANT SYSTEM
K Number: K854749
·
Decision Mar 6, 1986
Classifications
1
FEI Numbers
333
Registration Numbers
333
Same Product Code
1516
Applicant Total
3
Review Days
100
Basic Information
- Device Name
- STARTANIUS DENTAL IMPLANT SYSTEM
- K Number
- K854749
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- PARK DENTAL RESEARCH CORP.
- Date Received
- November 26, 1985
- Decision Date
- March 6, 1986
- 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.
HEXIM Implant; Samwon General Abutments
FDA 510(k)
FDA Class 2
·Dental
URIS Long Implant & Abutments
FDA 510(k)
FDA Class 2
·Dental
T3 Pro Implants ZimVie Packaging System
FDA 510(k)
FDA Class 2
·Dental
Bioline Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
MBA Biotech Implant System
FDA 510(k)
FDA Class 2
·Dental
CeraRoot TL Implant System (TL)
FDA 510(k)
FDA Class 2
·Dental