FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DEN-MAT SECURE ANTI-ROTATIONAL POST-CORE SYSTEM
K Number: K870130
·
Decision Feb 19, 1987
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
34
Applicant Total
29
Review Days
38
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
- DEN-MAT SECURE ANTI-ROTATIONAL POST-CORE SYSTEM
- K Number
- K870130
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3810
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Den-Mat Corp.
- Date Received
- January 12, 1987
- Decision Date
- February 19, 1987
- 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 Den-Mat Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K983106 | 1ST IMPRESSION | Feb 9, 1999 | Substantially Equivalent |
| K895731 | DEN-MAT CERINATE PORCELAIN | Aug 3, 1990 | Substantially Equivalent |
| K895269 | DEN-MAT LAMI-QUICK | Feb 22, 1990 | Substantially Equivalent |
| K881918 | LIGHT-CURED ZIONOMER CEMENT | Jul 15, 1988 | Substantially Equivalent |
| K875351 | DEN-MAT PORETCH (PORCELAIN ETCHANT) | Mar 18, 1988 | Substantially Equivalent |
| K872510 | DEN-MAT TENURE | Aug 24, 1987 | Substantially Equivalent |
| K864346 | REMBRANDT PORCELAIN TINTING KIT | Jan 7, 1987 | Substantially Equivalent |
| K862449 | DEN-MAT DENTIN LINK | Jul 22, 1986 | Substantially Equivalent |
| K860971 | DEN-MAT GOLD LINK (FORMERLY DEN-MAT METAL OPAQUER) | Mar 25, 1986 | Substantially Equivalent |
| K852630 | DEN-MAT PAINT-ON RUBBER DAM | Dec 18, 1985 | Substantially Equivalent |