FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEGUPRINT
K Number: K955465
·
Decision Dec 28, 1995
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
401
Applicant Total
24
Review Days
28
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Basic Information
- Device Name
- DEGUPRINT
- K Number
- K955465
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Degussa Corp.
- Date Received
- November 30, 1995
- Decision Date
- December 28, 1995
- Product Code
- ELW
- 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 |
|---|---|---|---|
| ELW | Material, Impression | FDA class 2 | Dental |
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Other Clearances by Degussa Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K973288 | STABILOR HN | Nov 19, 1997 | Substantially Equivalent |
| 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 |
| 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 |