FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE
K Number: K014133
·
Decision Mar 14, 2002
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
192
Applicant Total
78
Review Days
87
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE
- K Number
- K014133
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3750
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pulpdent Corp.
- Date Received
- December 17, 2001
- Decision Date
- March 14, 2002
- Product Code
- DYH
- 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 |
|---|---|---|---|
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DYH), ordered by most recent decision date.
BracePaste Prime Plus
FDA 510(k)
FDA Class 2
·Dental
Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree Adhesive
FDA 510(k)
FDA Class 2
·Dental
BracePaste Fluoride Sealant
FDA 510(k)
FDA Class 2
·Dental
3M Transbond Orthodontic Adhesive
FDA 510(k)
FDA Class 2
·Dental
AlignerFlow LC
FDA 510(k)
FDA Class 2
·Dental
TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Pulpdent Corp.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K974398 | PULPDENT CAVITY VARNISH | Feb 18, 1998 | Substantially Equivalent |