FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEVA PLUS
K Number: K921419
·
Decision May 26, 1992
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
193
Applicant Total
33
Review Days
63
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Basic Information
- Device Name
- DEVA PLUS
- K Number
- K921419
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3060
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Degussa AG
- Date Received
- March 24, 1992
- Decision Date
- May 26, 1992
- 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 AG
| K Number | Device Name | ||
|---|---|---|---|
| K953344 | DEGUBOND ULTRA | Aug 25, 1995 | Substantially Equivalent |
| K931808 | DUCERAGOLD, DUCERATIN | Nov 3, 1993 | 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 |
| 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 |