FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST
K Number: K080418
·
Decision Apr 30, 2008
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
14
Applicant Total
11
Review Days
75
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Basic Information
- Device Name
- REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST
- K Number
- K080418
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Regeneration Technologies, Inc.
- Date Received
- February 15, 2008
- Decision Date
- April 30, 2008
- 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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FDA Class 2
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PROGENIX PLUS
FDA 510(k)
FDA Class 2
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Other Clearances by Regeneration Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K072238 | BIOSET XCH | Jan 25, 2008 | Substantially Equivalent |
| K072327 | CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON | Oct 24, 2007 | Substantially Equivalent |
| K063584 | STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937 | May 9, 2007 | Substantially Equivalent |
| K060180 | BIOSET XC | Sep 6, 2006 | Substantially Equivalent |
| K060253 | STERLING INTERFERENCE SCREW HT, STERLING INTERFERENCE SCREW ST. | Feb 23, 2006 | Substantially Equivalent |
| K052405 | STERLING INTERFERENC SCREW HT | Nov 16, 2005 | Substantially Equivalent |
| K051615 | STERLING CANCELLOUS CHIPS; STERLING CANCELLOUS CUBES | Aug 15, 2005 | Substantially Equivalent |
| K050767 | STERLING INTERFERENCE SCREW ST | Jun 9, 2005 | Substantially Equivalent |
| K043421 | OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC | Feb 16, 2005 | Substantially Equivalent |
| K043420 | OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE | Feb 10, 2005 | Substantially Equivalent |