FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DUCERAGOLD, DUCERATIN
K Number: K931808
·
Decision Nov 3, 1993
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
38
Applicant Total
33
Review Days
205
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Basic Information
- Device Name
- DUCERAGOLD, DUCERATIN
- K Number
- K931808
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3920
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Degussa AG
- Date Received
- April 12, 1993
- Decision Date
- November 3, 1993
- Product Code
- ELL
- 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 |
|---|---|---|---|
| ELL | Teeth, Porcelain | FDA class 2 | Dental |
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Other Clearances by Degussa AG
| K Number | Device Name | ||
|---|---|---|---|
| K953344 | DEGUBOND ULTRA | Aug 25, 1995 | Substantially Equivalent |
| K926347 | DUCERANIUM U | May 27, 1993 | Substantially Equivalent |
| K922790 | DEGUCAST 40 | Dec 3, 1992 | Substantially Equivalent |
| K921772 | BIOLOR | Jul 13, 1992 | Substantially Equivalent |
| K921479 | DUCERATIN/DUCERAM LFC DENTAL PORCELAIN | Jun 22, 1992 | Substantially Equivalent |
| K921419 | DEVA PLUS | May 26, 1992 | Substantially Equivalent |
| K921445 | DEGUBOND PLUS | May 26, 1992 | Substantially Equivalent |
| K914340 | DUOMAT 3 AMALGAMATOR | Nov 13, 1991 | Substantially Equivalent |
| K914341 | MIXOMAT AMALGAMATOR | Nov 13, 1991 | Substantially Equivalent |
| K914368 | PART 872 DEGUFILL H & DEGUFILL M DA | Nov 13, 1991 | Substantially Equivalent |