FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THE STERN ROOT ANCHOR SYSTEM
K Number: K950213
·
Decision Mar 23, 1995
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
34
Applicant Total
16
Review Days
63
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
- THE STERN ROOT ANCHOR SYSTEM
- K Number
- K950213
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3810
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sterngold/Implamed
- Date Received
- January 19, 1995
- Decision Date
- March 23, 1995
- Product Code
- ELR
- 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 |
|---|---|---|---|
| ELR | Post, Root Canal | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ELR), ordered by most recent decision date.
FIBER-METAL POST
FDA 510(k)
FDA Class 1
·Dental
FRC POSTEC PLUS
FDA 510(k)
FDA Class 1
·Dental
EVERSTICK POST
FDA 510(k)
FDA Class 1
·Dental
FIBIOCORE
FDA 510(k)
FDA Class 1
·Dental
CARBON POST
FDA 510(k)
FDA Class 1
·Dental
FRC POSTEC
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by Sterngold/Implamed
| K Number | Device Name | ||
|---|---|---|---|
| K984341 | STERNVANTAGE VARNISH LC, MODEL 221001 | Jan 8, 1999 | Substantially Equivalent |
| K984340 | STERNOMEGA TEMPORARY CEMENT AUTOMIX NE, MODEL 220282/220281 | Jan 8, 1999 | Substantially Equivalent |
| K983786 | STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTTUMENTATION | Nov 13, 1998 | Substantially Equivalent |
| K982692 | STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC | Oct 22, 1998 | Substantially Equivalent |
| K982895 | STERNOMEGA COMPOMER CEMENT | Oct 9, 1998 | Substantially Equivalent |
| K981516 | STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFER TO TABLE 1 IN SUB | May 11, 1998 | Substantially Equivalent |
| K962326 | STERNGOLD BIO-5 (1127210) | Jul 24, 1996 | Substantially Equivalent |
| K962324 | STERNGOLD U-CPF METAL ALLOY (1067800) | Jul 24, 1996 | Substantially Equivalent |
| K962325 | QUASAR YELLOW CROWN AND BRIDGE ALLOY (1122015) | Jul 24, 1996 | Substantially Equivalent |
| K962304 | STERNGOLD BIO-4 | Jul 23, 1996 | Substantially Equivalent |