FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ROOT CANAL POST
K Number: K802515
·
Decision Nov 12, 1980
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
34
Applicant Total
23
Review Days
28
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Basic Information
- Device Name
- ROOT CANAL POST
- K Number
- K802515
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3810
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Unitek Corp.
- Date Received
- October 15, 1980
- Decision Date
- November 12, 1980
- 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 |
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Other Clearances by Unitek Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K944286 | METAL-LINED TRANSCEND CERAMIC BRACKET | Nov 29, 1994 | Substantially Equivalent |
| K933501 | ALASTIK | Apr 28, 1994 | Substantially Equivalent |
| K940165 | ALASTIK | Mar 7, 1994 | Substantially Equivalent |
| K923999 | ALASTIK NS | Jun 24, 1993 | Substantially Equivalent |
| K924645 | TRANSCEND SERIES 6000 DEBONDING INSTRUMENTS | Nov 25, 1992 | Substantially Equivalent |
| K924295 | DEBRACKETING INSTRUMENT | Nov 23, 1992 | Substantially Equivalent |
| K923432 | GERMAN MINI DYNALOCK | Oct 30, 1992 | Substantially Equivalent |
| K911271 | ADHESIVE PRECOATED BRACKETS | May 29, 1991 | Substantially Equivalent |
| K910288 | NONSTAINING ALASTIKS | Mar 29, 1991 | Substantially Equivalent |
| K890529 | ALASTIGARD | Mar 9, 1989 | Substantially Equivalent |