PMA P800035S010
- Device
- PERI-OSS
- Applicant
- Curasan AG
- PMA number
- P800035
- Supplement
- S010
- Product code
- DZE
- Decision date
- 2001-10-04
- Generic name
- Implant, endosseous, root-form
- Approval order statement
- APPROVAL FOR A NEW TRADE NAME. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME, PERI-OSS AND IS INDICATED FOR REPAIR OF PERIODONTAL AND PERIAPICAL BONY DEFECTS.
Current openFDA PMA Record#
- Device
- PERI-OSS
- Applicant
- Curasan AG
- PMA number
- P800035
- Supplement
- S010
- Product code
- DZE
- Generic name
- Implant, endosseous, root-form
- Decision date
- 2001-10-04
- Decision code
- APPR
- Date received
- 2001-06-25
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A NEW TRADE NAME. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME, PERI-OSS AND IS INDICATED FOR REPAIR OF PERIODONTAL AND PERIAPICAL BONY DEFECTS.