FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MAXIBOND
K Number: K884575
·
Decision Jan 3, 1989
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
192
Applicant Total
9
Review Days
63
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
- MAXIBOND
- K Number
- K884575
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3750
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Ortho Source
- Date Received
- November 1, 1988
- Decision Date
- January 3, 1989
- 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 Ortho Source
| K Number | Device Name | ||
|---|---|---|---|
| K913853 | FISSURE SEALER | Aug 27, 1992 | Substantially Equivalent |
| K913854 | ORTHO LIGHT CURE | Jan 14, 1992 | Substantially Equivalent |
| K913519 | SUMO GLASS IONOMER CEMENT | Nov 19, 1991 | Substantially Equivalent |
| K884949 | VISIBLE LIGHT CURE CALCIUM HYDROXIDE LINER | Feb 23, 1989 | Substantially Equivalent |
| K861118 | ORTHOJOIN, ORTHODONTIC ADHESIVE | May 2, 1986 | Substantially Equivalent |
| K861258 | PERMABAND (ORTHODONTIC ADHESIVE) | Apr 17, 1986 | Substantially Equivalent |
| K861245 | ORTHOSOURCE ETCH SYSTEMS | Apr 11, 1986 | Substantially Equivalent |
| K860959 | DEPENDABOND | Mar 25, 1986 | Substantially Equivalent |