FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYDROXI-FLEX IMPLANT
K Number: K812321
·
Decision Oct 29, 1981
Classifications
1
FEI Numbers
333
Registration Numbers
333
Same Product Code
1516
Applicant Total
5
Review Days
73
Basic Information
- Device Name
- HYDROXI-FLEX IMPLANT
- K Number
- K812321
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- IMPLADENT
- Date Received
- August 17, 1981
- Decision Date
- October 29, 1981
- 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
Other Clearances by IMPLADENT
| K Number | Device Name | ||
|---|---|---|---|
| K923310 | OSTEOGEN (HA RESORB) | May 31, 1995 | Substantially Equivalent |
| K881662 | EXPANDED CLAIMES TO OSTEOGEN(R) | Sep 1, 1988 | Substantially Equivalent for Some Indications |
| K843398 | OSTEOGEN | Dec 27, 1984 | Substantially Equivalent |
| K792663 | FLEXI-CUP IMPLANT | Jan 9, 1980 | Substantially Equivalent |