FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NCM - ALPHA ALLOY (DENTAL BAKE-ON ALLOY)
K Number: K860217
·
Decision Mar 17, 1986
Classifications
1
FEI Numbers
94
Registration Numbers
94
Same Product Code
152
Applicant Total
19
Review Days
54
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
- NCM - ALPHA ALLOY (DENTAL BAKE-ON ALLOY)
- K Number
- K860217
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3710
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Austenal Dental, Inc.
- Date Received
- January 22, 1986
- Decision Date
- March 17, 1986
- 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 Austenal Dental, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K890713 | OVERDENTURE - STUD ATTACHMENT | Jul 14, 1989 | Substantially Equivalent |
| K883799 | BASE, DENTURE, RELINING, REPAIRING, REBASING,RESIN | Oct 20, 1988 | Substantially Equivalent |
| K880875 | VITALLIUM EQUIPOISE ALLOY | Apr 7, 1988 | Substantially Equivalent |
| K871849 | LIGHT CURE DENTURE GLAZE | Aug 10, 1987 | Substantially Equivalent |
| K872746 | VITALLIUM WIRE | Jul 21, 1987 | Substantially Equivalent |
| K863630 | AUSTENAL ACUPAC 20 DENTURE BASE MATERIAL | Mar 11, 1987 | Substantially Equivalent |
| K862557 | AUSTENAL ACUSOFT SOFT LINER | Feb 19, 1987 | Substantially Equivalent |
| K865025 | AUSTENAL CONDENSING INSTRUMENT | Feb 19, 1987 | Substantially Equivalent |
| K864826 | A-SP ALLOY (SILVER-PALLADIUM CROWN & BRIDGE ALLOY) | Feb 10, 1987 | Substantially Equivalent |
| K862856 | PALLADIUM BASED DENT ALLOYS/PORCELAIN METAL RESTOR | Aug 26, 1986 | Substantially Equivalent |