FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ULTRA SPHERICAL AMALGAM ALLOY
K Number: K951865
·
Decision May 25, 1995
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
73
Applicant Total
4
Review Days
34
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
- ULTRA SPHERICAL AMALGAM ALLOY
- K Number
- K951865
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3070
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Goldsmith & Revere, Inc.
- Date Received
- April 21, 1995
- Decision Date
- May 25, 1995
- Product Code
- EJJ
- 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 |
|---|---|---|---|
| EJJ | Alloy, Amalgam | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EJJ), ordered by most recent decision date.
SILVERFIL
FDA 510(k)
FDA Class 2
·Dental
SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70
FDA 510(k)
FDA Class 2
·Dental
BESTALOY
FDA 510(k)
FDA Class 2
·Dental
BENCO ADMIX
FDA 510(k)
FDA Class 2
·Dental
BENCO SPHERICAL
FDA 510(k)
FDA Class 2
·Dental
HIGH SILVER CONVENTIONAL
FDA 510(k)
FDA Class 2
·Dental