FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NICKEL-BASED DENTAL CASTING ALLOY
K Number: K820328
·
Decision Mar 2, 1982
Classifications
1
FEI Numbers
94
Registration Numbers
94
Same Product Code
152
Applicant Total
279
Review Days
22
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
- NICKEL-BASED DENTAL CASTING ALLOY
- K Number
- K820328
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3710
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Dentsply Intl.
- Date Received
- February 8, 1982
- Decision Date
- March 2, 1982
- 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 Dentsply Intl.
| K Number | Device Name | ||
|---|---|---|---|
| K123615 | IRIS - HIGH STRENGTH GLASS CERAMIC | Feb 22, 2013 | Substantially Equivalent |
| K072730 | FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS | Mar 27, 2008 | Substantially Equivalent |
| K070538 | XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE | Mar 14, 2007 | Substantially Equivalent |
| K070019 | CARRARA VOLUMIA | Jan 26, 2007 | Substantially Equivalent |
| K061427 | PRE-IMPRESSION CONDITIONING SOLUTION | Jun 26, 2006 | Substantially Equivalent |
| K052334 | CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131 | Sep 2, 2005 | Substantially Equivalent |
| K051707 | ECLIPSE BONDING AGENT | Jul 15, 2005 | Substantially Equivalent |
| K051463 | XENO ADHESIVE WITH ACTIVATOR | Jul 12, 2005 | Substantially Equivalent |
| K051462 | MODIFICATION TO: CERCON BASE | Jun 24, 2005 | Substantially Equivalent |
| K050880 | DYRACT EXTRA RESTORATIVE | Apr 22, 2005 | Substantially Equivalent |