FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DYNAGRAFT II DENTAL
K Number: K043573
·
Decision Jul 29, 2005
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
14
Applicant Total
10
Review Days
214
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Basic Information
- Device Name
- DYNAGRAFT II DENTAL
- K Number
- K043573
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Isotis Orthobiologics, Inc.
- Date Received
- December 27, 2004
- Decision Date
- July 29, 2005
- 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
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EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC
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DBX DEMINERALIZED BONE MATRIX PUTTY
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PROGENIX
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PROGENIX PLUS
FDA 510(k)
FDA Class 2
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Other Clearances by Isotis Orthobiologics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K091193 | ACCELL EVO3C | Aug 10, 2009 | Substantially Equivalent |
| K081817 | ACCELL TBM-R | Sep 24, 2008 | Substantially Equivalent |
| K070751 | ORTHOBLAST II DBM DEMINERALIZED BONE MATRIX PASTE AND PUTTY | Oct 15, 2007 | Substantially Equivalent |
| K050642 | ORTHOBLAST II PUTTY AND PASTE | Dec 5, 2005 | Substantially Equivalent |
| K052098 | CONNEXUS, .5CC, MODEL 023000-005 | Sep 7, 2005 | Substantially Equivalent |
| K050690 | CONNEXUS | Jul 7, 2005 | Substantially Equivalent |
| K040419 | DYNAGRAFT II | Mar 25, 2005 | Substantially Equivalent |
| K042706 | OSSATURA DENTAL | Oct 20, 2004 | Substantially Equivalent |
| K041991 | ASPIREX - BONE MARROW ASPIRATE KIT | Sep 16, 2004 | Substantially Equivalent |