FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEGUCAST 40
K Number: K922790
·
Decision Dec 3, 1992
Classifications
1
FEI Numbers
94
Registration Numbers
94
Same Product Code
152
Applicant Total
33
Review Days
177
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- DEGUCAST 40
- K Number
- K922790
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3710
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Degussa AG
- Date Received
- June 9, 1992
- Decision Date
- December 3, 1992
- Product Code
- EJH
- 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 |
|---|---|---|---|
| EJH | Alloy, Metal, Base | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EJH), ordered by most recent decision date.
BEGOPAL+
FDA 510(k)
FDA Class 2
·Dental
CONTINUM V
FDA 510(k)
FDA Class 2
·Dental
CONTINUM
FDA 510(k)
FDA Class 2
·Dental
VERASOFT ES
FDA 510(k)
FDA Class 2
·Dental
DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST
FDA 510(k)
FDA Class 2
·Dental
WIROBOND C
FDA 510(k)
FDA Class 2
·Dental
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 |
| 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 |