FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GRAFTON DBM
K Number: K051188
·
Decision Jan 3, 2006
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
14
Applicant Total
24
Review Days
238
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
- GRAFTON DBM
- K Number
- K051188
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Osteotech, Inc.
- Date Received
- May 10, 2005
- Decision Date
- January 3, 2006
- Product Code
- NUN
- 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 |
|---|---|---|---|
| NUN | Bone Grafting Material, Human Source | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NUN), ordered by most recent decision date.
SURFUSE II GEL, SURFUSE II PUTTY, EXFUSE II GEL, EXFUSE II PUTTY
FDA 510(k)
FDA Class 2
·Dental
REGENEROSS ALLOGRAFT PLUS MINERLIZED
FDA 510(k)
FDA Class 2
·Dental
EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC
FDA 510(k)
FDA Class 2
·Dental
DBX DEMINERALIZED BONE MATRIX PUTTY
FDA 510(k)
FDA Class 2
·Dental
PROGENIX
FDA 510(k)
FDA Class 2
·Dental
PROGENIX PLUS
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Osteotech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K082615 | GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICES | Oct 16, 2008 | Substantially Equivalent |
| K081227 | PLEXUR M | Jul 22, 2008 | Substantially Equivalent |
| K080511 | PLEXUR-P | Apr 21, 2008 | Substantially Equivalent |
| K073405 | PLEXUR M | Mar 3, 2008 | Substantially Equivalent |
| K061982 | PLEXUR P | Feb 7, 2007 | Substantially Equivalent |
| K051781 | GRAFTCAGE TLX | Dec 16, 2005 | Substantially Equivalent |
| K051195 | GRAFTON DBM | Dec 16, 2005 | Substantially Equivalent |
| K043209 | VIAGRAF DBM PASTE | Dec 5, 2005 | Substantially Equivalent |
| K053080 | GRAFTCAGE ACX | Dec 1, 2005 | Substantially Equivalent |
| K042707 | GRAFTON PLUS DBM PASTE | Nov 30, 2005 | Substantially Equivalent |