FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OBA-MCP, Orthodontic Bracket Adhesive with MCP
K Number: K173020
·
Decision Jan 17, 2018
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
192
Applicant Total
32
Review Days
111
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
- OBA-MCP, Orthodontic Bracket Adhesive with MCP
- K Number
- K173020
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3750
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pulpdent Corporation
- Date Received
- September 28, 2017
- Decision Date
- January 17, 2018
- 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 Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K210045 | ACTIVA PRESTO PACK | Sep 22, 2021 | Substantially Equivalent |
| K172169 | Pulpdent (Activa) Pit and Fissure Sealant with MCP | Jan 5, 2018 | Substantially Equivalent |
| K153249 | Pulpdent Solo Flowable Composite with MCP | Apr 1, 2016 | Substantially Equivalent |
| K130223 | RMGI FILL | Mar 29, 2013 | Substantially Equivalent |
| K123265 | RMGI LOW VISCOSITY | Dec 7, 2012 | Substantially Equivalent |
| K120784 | TUFF-TEMP 2.0 | Jun 8, 2012 | Substantially Equivalent |
| K120003 | NUCAL | Apr 5, 2012 | Substantially Equivalent |
| K120213 | ETCH-RITE SUPREME | Mar 30, 2012 | Substantially Equivalent |
| K113818 | EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL | Mar 21, 2012 | Substantially Equivalent |
| K113711 | LIME-LITE II | Mar 5, 2012 | Substantially Equivalent |