FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
PULPDENT CANAL FINDER
K Number: K945811
·
Decision Jan 20, 1995
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
45
Applicant Total
78
Review Days
53
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Basic Information
- Device Name
- PULPDENT CANAL FINDER
- K Number
- K945811
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pulpdent Corp.
- Date Received
- November 28, 1994
- Decision Date
- January 20, 1995
- 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 Pulpdent Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K014133 | PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE | Mar 14, 2002 | Substantially Equivalent |
| K014138 | PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT | Mar 14, 2002 | Substantially Equivalent |
| K020115 | PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM | Feb 28, 2002 | Substantially Equivalent |
| K014059 | PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE | Feb 27, 2002 | Substantially Equivalent |
| K013411 | PULPDENT CAVITY PREPARATION IV | Dec 12, 2001 | Substantially Equivalent |
| K994180 | PULPDENT CAVITY PREPARATION III | Mar 2, 2000 | Substantially Equivalent |
| K994181 | PULPDENT CAVITY PREPARATION II, PULPDENT CAVITY PREPARATION II WUTH FLUORIDE | Feb 29, 2000 | Substantially Equivalent |
| K994182 | PULPDENT CAVITY PREPARATION 1, PULPDENT CAVITY PREPARATION 1 WITH FLUORIDE | Feb 23, 2000 | Substantially Equivalent |
| K993683 | PULPDENT UNO-DUO | Dec 13, 1999 | Substantially Equivalent |
| K974202 | PULPDENT CAVITY CLEANSER, PULPDENT CAVITY CLEANSER PLUS | Mar 19, 1998 | Substantially Equivalent |