FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KERR SEALAPEX ROOT CANAL SEALER
K Number: K841910
·
Decision Jul 13, 1984
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
76
Applicant Total
37
Review Days
65
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Basic Information
- Device Name
- KERR SEALAPEX ROOT CANAL SEALER
- K Number
- K841910
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3250
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Sybron Corp.
- Date Received
- May 9, 1984
- Decision Date
- July 13, 1984
- Product Code
- EJK
- 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 |
|---|---|---|---|
| EJK | Liner, Cavity, Calcium Hydroxide | FDA class 2 | Dental |
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Other Clearances by Sybron Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K862284 | SEALITE | Jun 23, 1986 | Substantially Equivalent |
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| K844092 | DIAGNOSTIC MICROSOPCE SLIDES | Oct 25, 1984 | Substantially Equivalent |
| K842132 | TYCOS SELF-CHECK/DIGITAL FEVER THERMO | Jul 18, 1984 | Substantially Equivalent |
| K841732 | LIEBEL-FLARSHEIM AFC 1000 X-RAY FILM | Jun 5, 1984 | Substantially Equivalent |
| K840469 | TYCOS SELF CHECK BPM3 BLOOD PRESS MONI | May 21, 1984 | Substantially Equivalent |
| K840407 | KERR RESIN BONDED BRIDGE CEMENT | May 21, 1984 | Substantially Equivalent |
| K840607 | LF MOTORIZED RADIOGRAPHIC FILM VIEWER | Mar 5, 1984 | Substantially Equivalent |
| K833138 | DIGITAL INJECTOR SYS | Nov 14, 1983 | Substantially Equivalent |
| K823795 | EVERBOND GLASS IONOMER CEMENT | Jan 26, 1983 | Substantially Equivalent |