FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NOBEL BIOCARE PERMANENT CENTRIC POST, MODELS 31234, 31235, 31236
K Number: K040573
·
Decision Apr 28, 2004
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
31
Review Days
55
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Basic Information
- Device Name
- NOBEL BIOCARE PERMANENT CENTRIC POST, MODELS 31234, 31235, 31236
- K Number
- K040573
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nobel Biocare Uas, Inc.
- Date Received
- March 4, 2004
- Decision Date
- April 28, 2004
- Product Code
- NHA
- 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 |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | FDA class 2 | Dental |
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Other Clearances by Nobel Biocare Uas, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K050444 | NOBELREPLACE ADAPTER, MODEL 32412 | Jul 7, 2005 | Substantially Equivalent |
| K042658 | PROCERA ABUTMENT BRANEMARK, MODELS 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004 | Oct 20, 2004 | Substantially Equivalent |
| K041661 | NOBEL BIOCARE ENDOSSEOUS IMPLANTS | Aug 26, 2004 | Substantially Equivalent |
| K041876 | NOBELDIRECT OD IMPLANT | Aug 20, 2004 | Substantially Equivalent |
| K041312 | NOBELRONDO DENTAL CERAMIC-ALUMINA | Jul 23, 2004 | Substantially Equivalent |
| K041275 | PROCERA ABUTMENT OCTAGON | May 27, 2004 | Substantially Equivalent |
| K033724 | NOBEL BIOCARE CENTRIC POST, MODELS 31234, 31235 AND 31236 | Feb 23, 2004 | Substantially Equivalent |
| K031345 | NOBEL DIRECT, MODELS 30937, 30938 | Jul 24, 2003 | Substantially Equivalent |
| K030257 | NOBEL PERFECT IMPLANT SYSTEM | Feb 10, 2003 | Substantially Equivalent |
| K023952 | REPLACE ONE PIECE IMPLANT, HA, REPLACE ONE PIECE IMPLANT, TIUNITE | Jan 16, 2003 | Substantially Equivalent |