FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇷 Greece
DMP SINGLE BONDING
K Number: K102254
·
Decision Nov 23, 2010
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
418
Applicant Total
6
Review Days
105
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
- DMP SINGLE BONDING
- K Number
- K102254
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Dmp, Ltd.
- Date Received
- August 10, 2010
- Decision Date
- November 23, 2010
- Product Code
- KLE
- 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 |
|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KLE), ordered by most recent decision date.
Any-Etch
FDA 510(k)
FDA Class 2
·Dental
Porcelain Etch Gel
FDA 510(k)
FDA Class 2
·Dental
Adhese 2
FDA 510(k)
FDA Class 2
·Dental
Bond-PR Universal Adhesive
FDA 510(k)
FDA Class 2
·Dental
VITA VMLC Primer
FDA 510(k)
FDA Class 2
·Dental
els unibond
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Dmp, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K121915 | BRIGHT RESTORATIVE MATERIALS | Sep 28, 2012 | Substantially Equivalent |
| K102836 | BONASIL A+ IMPRESSION MATERIALS | Jan 13, 2011 | Substantially Equivalent |
| K102252 | DMP PIT & FISSURE SEALANT | Dec 3, 2010 | Substantially Equivalent |
| K102255 | DMP ETCHING GEL | Nov 23, 2010 | Substantially Equivalent |
| K102257 | NANOCERAM- BRIGHT | Nov 19, 2010 | Substantially Equivalent |