FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
ENDOCATER
K Number: K863393
·
Decision Jun 11, 1987
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
45
Applicant Total
16
Review Days
281
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Basic Information
- Device Name
- ENDOCATER
- K Number
- K863393
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- The Hygenic Corp.
- Date Received
- September 3, 1986
- Decision Date
- June 11, 1987
- Product Code
- LQY
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LQY | Locator, Root Apex | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LQY), ordered by most recent decision date.
Apex Locator (FindPex)
FDA 510(k)
FDA Unclassified
·Unknown
Apex Locator
FDA 510(k)
FDA Unclassified
·Unknown
Electronic Apex Locator (Alpha Apex I)
FDA 510(k)
FDA Unclassified
·Unknown
Apex Locator
FDA 510(k)
FDA Unclassified
·Unknown
Apex Locator (AL-Pex), Apex Locator (AL-Pex+)
FDA 510(k)
FDA Unclassified
·Unknown
Root Apex Locator
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by The Hygenic Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K954990 | DENTAL DAM | Jan 26, 1996 | Substantially Equivalent |
| K930764 | ENDO-ICE-PULP TESTER-THERMAL | May 27, 1993 | Substantially Equivalent |
| K905418 | GATES GLIDDEN DRILLS | Jul 25, 1991 | Substantially Equivalent |
| K911225 | TRAY DOUGH | Apr 17, 1991 | Substantially Equivalent |
| K905640 | SOLID CORE GUTTA PERCHA CARRIER | Mar 5, 1991 | Substantially Equivalent |
| K900301 | NOVUS BONDING AGENT | May 15, 1990 | Substantially Equivalent |
| K900844 | WEDJETS | Apr 16, 1990 | Substantially Equivalent |
| K894092 | DENTAL ENDODONTIC CEMENT (MODIFICATION) | Jan 10, 1990 | Substantially Equivalent |
| K881826 | ENDO-ICE | Aug 23, 1988 | Substantially Equivalent for Some Indications |
| K873644 | PULP PEN | Oct 27, 1987 | Substantially Equivalent |