FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STABILOR HN
K Number: K973288
·
Decision Nov 19, 1997
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
193
Applicant Total
24
Review Days
78
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Basic Information
- Device Name
- STABILOR HN
- K Number
- K973288
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3060
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Degussa Corp.
- Date Received
- September 2, 1997
- Decision Date
- November 19, 1997
- 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 Degussa Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K972910 | PORS ON LITE | Oct 14, 1997 | Substantially Equivalent |
| K960256 | DEGUDENT LS | Feb 21, 1996 | Substantially Equivalent |
| K960226 | DG 88 | Feb 14, 1996 | Substantially Equivalent |
| K960104 | BIOCCLUS 4 | Feb 6, 1996 | Substantially Equivalent |
| K955465 | DEGUPRINT | Dec 28, 1995 | Substantially Equivalent |
| K955118 | DEGUBOND X-LITE PLUS | Dec 11, 1995 | Substantially Equivalent |
| K955027 | DEGUBOND X-LITE | Dec 1, 1995 | Substantially Equivalent |
| K951789 | PALLIAG NF IV | Jun 14, 1995 | Substantially Equivalent |
| K951791 | DEPALOR | Jun 12, 1995 | Substantially Equivalent |
| K951788 | DEGULOR S | Jun 12, 1995 | Substantially Equivalent |