FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OSSEOTITE 2 DENTAL IMPLANTS
K Number: K111216
·
Decision Nov 18, 2011
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
13
Review Days
200
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Basic Information
- Device Name
- OSSEOTITE 2 DENTAL IMPLANTS
- K Number
- K111216
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomet 3i, Inc.
- Date Received
- May 2, 2011
- Decision Date
- November 18, 2011
- 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 |
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Other Clearances by Biomet 3i, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K110565 | ABUTMENTS FOR COMPETITIVE IMPLANT SYSTEMS-NOBEL REPLACE | Sep 1, 2011 | Substantially Equivalent |
| K100724 | OSSEOTITE II MODEL XIFOSSXXX | Apr 1, 2011 | Substantially Equivalent |
| K101607 | BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS - ENCODE ABUTMENTS | Mar 11, 2011 | Substantially Equivalent |
| K101608 | BIOMET 3I PATIENT SPECIFIC DENTAL ABUTMENTS-ENCODE ABUTMENTS | Mar 11, 2011 | Substantially Equivalent |
| K102209 | ENCODE PATIENT SPECIFIC ABUTMENT | Dec 3, 2010 | Substantially Equivalent |
| K101582 | CAM STRUCTSURE BARS | Nov 8, 2010 | Substantially Equivalent |
| K092341 | LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION | Nov 30, 2009 | Substantially Equivalent |
| K080864 | CAM STRUCTSURE PRECISION MILLED BARS | Jul 21, 2008 | Substantially Equivalent |
| K073345 | CERTAIN CONTOURED MARGIN CERAMIC ABUTMENT | Mar 7, 2008 | Substantially Equivalent |
| K072363 | NANOTITE PREVAIL,CERTAIN,PARELLEL WALLED,TAPERED,EXTERNAL HEX | Jan 31, 2008 | Substantially Equivalent |