FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PULPDENT CERVICAL RESTORATIVE
K Number: K945113
·
Decision Dec 14, 1994
Classifications
1
FEI Numbers
205
Registration Numbers
205
Same Product Code
913
Applicant Total
78
Review Days
57
Basic Information
- Device Name
- PULPDENT CERVICAL RESTORATIVE
- K Number
- K945113
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PULPDENT CORP.
- Date Received
- October 18, 1994
- Decision Date
- December 14, 1994
- Product Code
- EBF
- 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | FDA class 2 | Dental |
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Other Clearances by PULPDENT CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K014138 | PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT | Mar 14, 2002 | Substantially Equivalent |
| K014133 | PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE | 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 |