FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STERNGOLD 1, MODEL 1127781
K Number: K022252
·
Decision Sep 19, 2002
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
193
Applicant Total
12
Review Days
69
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Basic Information
- Device Name
- STERNGOLD 1, MODEL 1127781
- K Number
- K022252
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 872.3060
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sterngold
- Date Received
- July 12, 2002
- Decision Date
- September 19, 2002
- Product Code
- EJS
- 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 |
|---|---|---|---|
| EJS | Alloy, Other Noble Metal | FDA class 2 | Dental |
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Other Clearances by Sterngold
| K Number | Device Name | ||
|---|---|---|---|
| K092434 | STERNGOLD 2.2MM ANGLES MICRO ERA DENTAL IMPLANT SYSTEM | Nov 10, 2009 | Substantially Equivalent |
| K041271 | STERNGOLD 3.25 ERA DENTAL IMPLANT SYSTEM | Oct 28, 2004 | Substantially Equivalent |
| K023580 | STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEM | Jan 17, 2003 | Substantially Equivalent |
| K021045 | ERA IMPLANT | Jun 26, 2002 | Substantially Equivalent |
| K021741 | CRITERTION, MODEL #1067511 | Jun 26, 2002 | Substantially Equivalent |
| K021367 | STERNGOLD 66, MODEL #1180230 | May 16, 2002 | Substantially Equivalent |
| K020949 | APOLLO, MODEL 1124525 | Apr 4, 2002 | Substantially Equivalent |
| K020391 | STERN MICRO ERA ATTACHMENT SYSTEM | Mar 8, 2002 | Substantially Equivalent |
| K003007 | GALAXY | Nov 17, 2000 | Substantially Equivalent |
| K991436 | STERNGOLD IMPLAMED NARROW PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTRUMENTATION | May 7, 1999 | Substantially Equivalent |