FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNITE BONDING ADHESIVE
K Number: K014142
·
Decision Feb 28, 2002
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
192
Applicant Total
6
Review Days
73
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
- UNITE BONDING ADHESIVE
- K Number
- K014142
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3750
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- 3M Unitek
- Date Received
- December 17, 2001
- Decision Date
- February 28, 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 3M Unitek
| K Number | Device Name | ||
|---|---|---|---|
| K100536 | TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE | Jul 27, 2010 | Substantially Equivalent |
| K073697 | TRANSBOND SUPREME ADHESIVE | Feb 15, 2008 | Substantially Equivalent |
| K062305 | CLARITY MODIFIED CERAMIC BRACKETS | Oct 18, 2006 | Substantially Equivalent |
| K020394 | APC PLUS ADHESIVE | Apr 12, 2002 | Substantially Equivalent |
| K950514 | TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT | Mar 7, 1995 | Substantially Equivalent |