FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TYTIN R
K Number: K951663
·
Decision Jun 6, 1995
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
73
Applicant Total
32
Review Days
57
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
- TYTIN R
- K Number
- K951663
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3070
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kerr Corporation (Danbury)
- Date Received
- April 10, 1995
- Decision Date
- June 6, 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
Other Clearances by Kerr Corporation (Danbury)
| K Number | Device Name | ||
|---|---|---|---|
| K051545 | L.E. DEMETRON II | Jul 18, 2005 | Substantially Equivalent |
| K020091 | OPTILUX 501 | Mar 21, 2002 | Substantially Equivalent |
| K951511 | TYTIN ADMIX | May 2, 1995 | Substantially Equivalent |
| K942480 | M4 CONTRA-ANGLE HANDPIECE | Jan 27, 1995 | Substantially Equivalent |
| K940513 | OPTIBOND | Apr 15, 1994 | Substantially Equivalent |
| K935535 | TYTIN | Mar 11, 1994 | Substantially Equivalent |
| K934690 | KERR OPTIBOND, MODIFICATION | Dec 30, 1993 | Substantially Equivalent |
| K923546 | OPTIBOND | Sep 29, 1992 | Substantially Equivalent |
| K915847 | AUTOMIX DENTAL AMALGAMATOR | Mar 2, 1992 | Substantially Equivalent |
| K904756 | MATRICS | Mar 15, 1991 | Substantially Equivalent |