FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DUCERATIN/DUCERAM LFC DENTAL PORCELAIN
K Number: K921479
·
Decision Jun 22, 1992
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
481
Applicant Total
33
Review Days
84
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Basic Information
- Device Name
- DUCERATIN/DUCERAM LFC DENTAL PORCELAIN
- K Number
- K921479
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Degussa AG
- Date Received
- March 30, 1992
- Decision Date
- June 22, 1992
- Product Code
- EIH
- 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 |
|---|---|---|---|
| EIH | Powder, Porcelain | FDA class 2 | Dental |
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|---|---|---|---|
| K953344 | DEGUBOND ULTRA | Aug 25, 1995 | Substantially Equivalent |
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| K926347 | DUCERANIUM U | May 27, 1993 | Substantially Equivalent |
| K922790 | DEGUCAST 40 | Dec 3, 1992 | Substantially Equivalent |
| K921772 | BIOLOR | Jul 13, 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 |