FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROCERA ALL-CERAMIC PORCELAIN
K Number: K944702
·
Decision Dec 2, 1994
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
481
Applicant Total
64
Review Days
71
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Basic Information
- Device Name
- PROCERA ALL-CERAMIC PORCELAIN
- K Number
- K944702
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nobelpharma USA, Inc.
- Date Received
- September 22, 1994
- Decision Date
- December 2, 1994
- 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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| K961737 | CERA ONE ABUTMENT SYSTEM | Jul 10, 1996 | Substantially Equivalent |
| K961728 | MIRUSCONE ABUTMENT SYSTEM | Jul 10, 1996 | Substantially Equivalent |
| K960639 | ABUTMENT SELECTION KIT | May 14, 1996 | Substantially Equivalent |
| K955697 | ABUTMENT RETRIEVAL KIT | Jan 30, 1996 | Substantially Equivalent |
| K955372 | BALL ATTACHMENT SYSTEM | Jan 23, 1996 | Substantially Equivalent |