FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STRAUMANN EXTRAORAL IMPLANT SYSTEM
K Number: K990458
·
Decision Apr 16, 1999
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
12
Applicant Total
41
Review Days
63
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Basic Information
- Device Name
- STRAUMANN EXTRAORAL IMPLANT SYSTEM
- K Number
- K990458
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.3800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Straumann USA
- Date Received
- February 12, 1999
- Decision Date
- April 16, 1999
- Product Code
- KCZ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| KCZ | Prosthesis, Breast, External, Used With Adhesive | FDA class 1 | General, Plastic Surgery |
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|---|---|---|---|
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| K130808 | STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWS | Jun 28, 2013 | Substantially Equivalent |
| K130724 | CODIAGNOSTIX IMPLANT PLANNING SOFTWARE | Jun 28, 2013 | Substantially Equivalent |
| K122855 | TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS | Dec 12, 2012 | Substantially Equivalent |
| K121131 | BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM | Jun 6, 2012 | Substantially Equivalent |
| K113606 | NNC GOLD ABUTMENT FOR BRIDGES | Jan 27, 2012 | Substantially Equivalent |
| K113410 | NNC SOLID ABUTMENT NNC TEMPORARY COPING FOR COLID ABUTMENT NNC TEMPORARY CAP FOR COLID ABUTMENT | Jan 13, 2012 | Substantially Equivalent |
| K113283 | NNC CEMENTABLE ABUTMENT STRAIGHT,15 DEGREE ANGLE, TYPE A ,15 DEGREE ANGLE, TYPE B,NNC BASAL SCREW CEMENTABLE ABUTMENTS | Dec 28, 2011 | Substantially Equivalent |
| K112280 | STRAUMANN CARES SCREW-RETAINED BRIDGE TITANIUM, STRAUMANN CARES DOLDER BAR TITANIUM | Nov 16, 2011 | Substantially Equivalent |
| K111357 | STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT SYSTEM | Oct 3, 2011 | Substantially Equivalent |