FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROCERA ALLCERAM FUSING MATERIAL
K Number: K983453
·
Decision Nov 18, 1998
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
481
Applicant Total
31
Review Days
49
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Basic Information
- Device Name
- PROCERA ALLCERAM FUSING MATERIAL
- K Number
- K983453
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nobel Biocare Uas, Inc.
- Date Received
- September 30, 1998
- Decision Date
- November 18, 1998
- Product Code
- EIH
- 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 |
|---|---|---|---|
| EIH | Powder, Porcelain | FDA class 2 | Dental |
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|---|---|---|---|
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| K041275 | PROCERA ABUTMENT OCTAGON | May 27, 2004 | Substantially Equivalent |
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| K031345 | NOBEL DIRECT, MODELS 30937, 30938 | Jul 24, 2003 | Substantially Equivalent |
| K030257 | NOBEL PERFECT IMPLANT SYSTEM | Feb 10, 2003 | Substantially Equivalent |