FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RESCUE IMPLANT SYSTEM
K Number: K053353
·
Decision Apr 19, 2006
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
9
Review Days
138
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Basic Information
- Device Name
- RESCUE IMPLANT SYSTEM
- K Number
- K053353
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Megagen Co., Ltd.
- Date Received
- December 2, 2005
- Decision Date
- April 19, 2006
- 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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Other Clearances by Megagen Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K110955 | ANYRIDGE INTERNAL IMPLANT SYSTEM | Nov 22, 2011 | Substantially Equivalent |
| K101890 | BALL ABUTMENT SYSTEM | Feb 3, 2011 | Substantially Equivalent |
| K073058 | RESCUE INTERNAL IMPLANT SYSTEM | Apr 11, 2008 | Substantially Equivalent |
| K070562 | EZ PLUS IMPLANT SYSTEM | May 18, 2007 | Substantially Equivalent |
| K063216 | RESCUE INTERNAL IMPLANT SYSTEM | Apr 2, 2007 | Substantially Equivalent |
| K053354 | INTERMEZZO PLUS FIXTURE | Apr 13, 2006 | Substantially Equivalent |
| K052369 | EXFEEL IMPLANT SYSTEM | Jan 10, 2006 | Substantially Equivalent |
| K051018 | INTERMEZZO IMPLANT SYSTEMS | Sep 2, 2005 | Substantially Equivalent |