FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RIGHT-ON ADHESIVE BOUDING SYSTEM
K Number: K952643
·
Decision Jul 11, 1995
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
192
Applicant Total
5
Review Days
32
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
- RIGHT-ON ADHESIVE BOUDING SYSTEM
- K Number
- K952643
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3750
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Tp Orthodontics, Inc.
- Date Received
- June 9, 1995
- Decision Date
- July 11, 1995
- 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 Tp Orthodontics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K214054 | TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 | Oct 14, 2022 | Substantially Equivalent |
| K193385 | TP Orthodontics Clear Aligner System | Nov 12, 2020 | Substantially Equivalent |
| K111234 | CLICK-IT | May 13, 2011 | Substantially Equivalent |
| K950992 | CERAMAFLEX BRACKET SYSTEM | May 3, 1995 | Substantially Equivalent |