FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BRANEMARK SYSTEM MIRUSCONE ABUTMENT SYSTEM
K Number: K944964
·
Decision Feb 28, 1995
Classifications
1
FEI Numbers
333
Registration Numbers
333
Same Product Code
1516
Applicant Total
64
Review Days
144
Basic Information
- Device Name
- BRANEMARK SYSTEM MIRUSCONE ABUTMENT SYSTEM
- K Number
- K944964
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- NOBELPHARMA USA, INC.
- Date Received
- October 7, 1994
- Decision Date
- February 28, 1995
- 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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| K Number | Device Name | ||
|---|---|---|---|
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| K962130 | BRANEMARK SYSTEMS MKII SELK-TAPPING FIXTURE | Jul 22, 1996 | Substantially Equivalent |
| K961736 | 17 ANGULATED ABUTMENT | Jul 18, 1996 | Substantially Equivalent |
| K961728 | MIRUSCONE ABUTMENT SYSTEM | Jul 10, 1996 | Substantially Equivalent |
| K961737 | CERA ONE 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 |